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Short-term, Long-term and Cost-effectiveness of Treating Depression and Anxiety Disorders in Children and Adolescents

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ClinicalTrials.gov Identifier: NCT03333239
Recruitment Status : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
University of Bremen
Information provided by (Responsible Party):
Silke Wiegand-Grefe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE September 4, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date December 21, 2017
Estimated Study Start Date  ICMJE December 22, 2017
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
  • Change from baseline children´s psychiatric symptomatology at 12 months [ Time Frame: baseline and 12 months ]
    Children´s psychiatric symptomatology will be assessed in all groups (intervention groups and control group) by an external independent interview (Kiddie-SADS; Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project.
  • Change from baseline children´s psychiatric symptomatology at 24 months [ Time Frame: baseline and 24 months ]
    Children´s psychiatric symptomatology will be assessed in all groups (intervention groups and control group) by an external independent interview (Kiddie-SADS; Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project.
  • Change from baseline children´s psychiatric symptomatology at 36 months [ Time Frame: baseline and 36 months ]
    Children´s psychiatric symptomatology will be assessed in all groups (intervention groups and control group) by an external independent interview (Kiddie-SADS; Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project.
  • Change from baseline children´s psychiatric symptomatology at 48 months [ Time Frame: baseline and 48 months ]
    Children´s psychiatric symptomatology will be assessed in all groups (intervention groups and control group) by an external independent interview (Kiddie-SADS; Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project.
  • Change from baseline children´s psychiatric symptomatology at 60 months [ Time Frame: baseline and 60 months ]
    Children´s psychiatric symptomatology will be assessed in all groups (intervention groups and control group) by an external independent interview (Kiddie-SADS; Kaufman et al., 1996). The Kiddie-SADS interview will be conducted by a trained rater external to the project.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03333239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
  • Change from baseline children´s depressive symptomatology at 12 months [ Time Frame: baseline and 12 months ]
    Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, & Duda, 2000). The German version of the "Children´s depression inventory" consists of 26 Items. Each item has 3 response options, which range from 0 = "symptom not present" to 2 = "symptom is very much present". The items are summed up to a total score (0-52), with higher values representing a higher number and more severe depressive symptoms.
  • Change from baseline children´s depressive symptomatology at 24 months [ Time Frame: baseline and 24 months ]
    Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, & Duda, 2000). The German version of the "Children´s depression inventory" consists of 26 Items. Each item has 3 response options, which range from 0 = "symptom not present" to 2 = "symptom is very much present". The items are summed up to a total score (0-52), with higher values representing a higher number and more severe depressive symptoms.
  • Change from baseline children´s depressive symptomatology at 36 months [ Time Frame: baseline and 36 months ]
    Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, & Duda, 2000). The German version of the "Children´s depression inventory" consists of 26 Items. Each item has 3 response options, which range from 0 = "symptom not present" to 2 = "symptom is very much present". The items are summed up to a total score (0-52), with higher values representing a higher number and more severe depressive symptoms.
  • Change from baseline children´s depressive symptomatology at 48 months [ Time Frame: baseline and 48 months ]
    Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, & Duda, 2000). The German version of the "Children´s depression inventory" consists of 26 Items. Each item has 3 response options, which range from 0 = "symptom not present" to 2 = "symptom is very much present". The items are summed up to a total score (0-52), with higher values representing a higher number and more severe depressive symptoms.
  • Change from baseline children´s depressive symptomatology at 60 months [ Time Frame: baseline and 60 months ]
    Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, & Duda, 2000). The German version of the "Children´s depression inventory" consists of 26 Items. Each item has 3 response options, which range from 0 = "symptom not present" to 2 = "symptom is very much present". The items are summed up to a total score (0-52), with higher values representing a higher number and more severe depressive symptoms.
  • Change from baseline children´s anxiety at 12 months [ Time Frame: baseline and 12 months ]
    Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, & McCanzie, 1995). The German version of the Scared consists of 41 items. Each item has 3 response options, which range from 0 = "not true or hardly ever true" to 2 = "true or often true". The subscales to be calculated are "panic/somatic" with a summed score ranging from 0 to 26, "generalized anxiety" with a summed score ranging from 0 to 18, "separation anxiety" with a summed score ranging from 0 to 16, "social phobia" with a summed score ranging from 0 to 14 and "school phobia" with a summed score ranging from 0 to 8. A total score can be obtained ranging from 0 to 82 by summing all scores. For all subscales and the total score higher values indicate a higher degree of anxiety.
  • Change from baseline children´s anxiety at 24 months [ Time Frame: baseline and 24 months ]
    Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, & McCanzie, 1995). The German version of the Scared consists of 41 items. Each item has 3 response options, which range from 0 = "not true or hardly ever true" to 2 = "true or often true". The subscales to be calculated are "panic/somatic" with a summed score ranging from 0 to 26, "generalized anxiety" with a summed score ranging from 0 to 18, "separation anxiety" with a summed score ranging from 0 to 16, "social phobia" with a summed score ranging from 0 to 14 and "school phobia" with a summed score ranging from 0 to 8. A total score can be obtained ranging from 0 to 82 by summing all scores. For all subscales and the total score higher values indicate a higher degree of anxiety.
  • Change from baseline children´s anxiety at 36 months [ Time Frame: baseline and 36 months ]
    Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, & McCanzie, 1995). The German version of the Scared consists of 41 items. Each item has 3 response options, which range from 0 = "not true or hardly ever true" to 2 = "true or often true". The subscales to be calculated are "panic/somatic" with a summed score ranging from 0 to 26, "generalized anxiety" with a summed score ranging from 0 to 18, "separation anxiety" with a summed score ranging from 0 to 16, "social phobia" with a summed score ranging from 0 to 14 and "school phobia" with a summed score ranging from 0 to 8. A total score can be obtained ranging from 0 to 82 by summing all scores. For all subscales and the total score higher values indicate a higher degree of anxiety.
  • Change from baseline children´s anxiety at 48 months [ Time Frame: baseline and 48 months ]
    Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, & McCanzie, 1995). The German version of the Scared consists of 41 items. Each item has 3 response options, which range from 0 = "not true or hardly ever true" to 2 = "true or often true". The subscales to be calculated are "panic/somatic" with a summed score ranging from 0 to 26, "generalized anxiety" with a summed score ranging from 0 to 18, "separation anxiety" with a summed score ranging from 0 to 16, "social phobia" with a summed score ranging from 0 to 14 and "school phobia" with a summed score ranging from 0 to 8. A total score can be obtained ranging from 0 to 82 by summing all scores. For all subscales and the total score higher values indicate a higher degree of anxiety.
  • Change from baseline children´s anxiety at 60 months [ Time Frame: baseline and 60 months ]
    Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, & McCanzie, 1995). The German version of the Scared consists of 41 items. Each item has 3 response options, which range from 0 = "not true or hardly ever true" to 2 = "true or often true". The subscales to be calculated are "panic/somatic" with a summed score ranging from 0 to 26, "generalized anxiety" with a summed score ranging from 0 to 18, "separation anxiety" with a summed score ranging from 0 to 16, "social phobia" with a summed score ranging from 0 to 14 and "school phobia" with a summed score ranging from 0 to 8. A total score can be obtained ranging from 0 to 82 by summing all scores. For all subscales and the total score higher values indicate a higher degree of anxiety.
  • Change from baseline parent reported children´s psychiatric symptoms at 12 months [ Time Frame: baseline and 12 months ]
    Children´s psychiatric disorders will be assessed by parents´ rating of the German version of the "Child behavior checklist" (CBCL; Achenbach, 1991). The German version of the CBCL consists of 118 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 18, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 28, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 22, "dissocial behavior" with scores ranging from 0 - 26, "aggressive behavior" with scores ranging from 0 - 40 and "other difficulties" with scores ranging from 0 - 66. A total score can be calculated by summing with scores ranging from 0 - 236. For all scales higher values indicate a higher problem level.
  • Change from baseline parent reported children´s psychiatric symptoms at 24 months [ Time Frame: baseline and 24 months ]
    Children´s psychiatric disorders will be assessed by parents´ rating of the German version of the "Child behavior checklist" (CBCL; Achenbach, 1991). The German version of the CBCL consists of 118 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 18, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 28, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 22, "dissocial behavior" with scores ranging from 0 - 26, "aggressive behavior" with scores ranging from 0 - 40 and "other difficulties" with scores ranging from 0 - 66. A total score can be calculated by summing with scores ranging from 0 - 236. For all scales higher values indicate a higher problem level.
  • Change from baseline parent reported children´s psychiatric symptoms at 36 months [ Time Frame: baseline and 36 months ]
    Children´s psychiatric disorders will be assessed by parents´ rating of the German version of the "Child behavior checklist" (CBCL; Achenbach, 1991). The German version of the CBCL consists of 118 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 18, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 28, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 22, "dissocial behavior" with scores ranging from 0 - 26, "aggressive behavior" with scores ranging from 0 - 40 and "other difficulties" with scores ranging from 0 - 66. A total score can be calculated by summing with scores ranging from 0 - 236. For all scales higher values indicate a higher problem level.
  • Change from baseline parent reported children´s psychiatric symptoms at 48 months [ Time Frame: baseline and 48 months ]
    Children´s psychiatric disorders will be assessed by parents´ rating of the German version of the "Child behavior checklist" (CBCL; Achenbach, 1991). The German version of the CBCL consists of 118 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 18, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 28, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 22, "dissocial behavior" with scores ranging from 0 - 26, "aggressive behavior" with scores ranging from 0 - 40 and "other difficulties" with scores ranging from 0 - 66. A total score can be calculated by summing with scores ranging from 0 - 236. For all scales higher values indicate a higher problem level.
  • Change from baseline parent reported children´s psychiatric symptoms at 60 months [ Time Frame: baseline and 60 months ]
    Children´s psychiatric disorders will be assessed by parents´ rating of the German version of the "Child behavior checklist" (CBCL; Achenbach, 1991). The German version of the CBCL consists of 118 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 18, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 28, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 22, "dissocial behavior" with scores ranging from 0 - 26, "aggressive behavior" with scores ranging from 0 - 40 and "other difficulties" with scores ranging from 0 - 66. A total score can be calculated by summing with scores ranging from 0 - 236. For all scales higher values indicate a higher problem level.
  • Change from baseline children´s self reported psychiatric symptoms at 12 months [ Time Frame: baseline and 12 months ]
    Children´s psychiatric disorders will further be assessed by children´s rating of the German version of the "Youth self report" (YSR; Achenbach, 1991). The German version of the YSR consists of 119 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 14, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 32, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 18, "dissocial behavior" with scores ranging from 0 - 22, "aggressive behavior" with scores ranging from 0 - 38 and "other difficulties" with scores ranging from 0 - 40. A total score can be calculated by summing with scores ranging from 0 - 238. For all scales higher values indicate a higher problem level.
  • Change from baseline children´s self reported psychiatric symptoms at 24 months [ Time Frame: baseline and 24 months ]
    Children´s psychiatric disorders will further be assessed by children´s rating of the German version of the "Youth self report" (YSR; Achenbach, 1991). The German version of the YSR consists of 119 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 14, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 32, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 18, "dissocial behavior" with scores ranging from 0 - 22, "aggressive behavior" with scores ranging from 0 - 38 and "other difficulties" with scores ranging from 0 - 40. A total score can be calculated by summing with scores ranging from 0 - 238. For all scales higher values indicate a higher problem level.
  • Change from baseline children´s self reported psychiatric symptoms at 36 months [ Time Frame: baseline and 36 months ]
    Children´s psychiatric disorders will further be assessed by children´s rating of the German version of the "Youth self report" (YSR; Achenbach, 1991). The German version of the YSR consists of 119 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 14, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 32, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 18, "dissocial behavior" with scores ranging from 0 - 22, "aggressive behavior" with scores ranging from 0 - 38 and "other difficulties" with scores ranging from 0 - 40. A total score can be calculated by summing with scores ranging from 0 - 238. For all scales higher values indicate a higher problem level.
  • Change from baseline children´s self reported psychiatric symptoms at 48 months [ Time Frame: baseline and 48 months ]
    Children´s psychiatric disorders will further be assessed by children´s rating of the German version of the "Youth self report" (YSR; Achenbach, 1991). The German version of the YSR consists of 119 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 14, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 32, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 18, "dissocial behavior" with scores ranging from 0 - 22, "aggressive behavior" with scores ranging from 0 - 38 and "other difficulties" with scores ranging from 0 - 40. A total score can be calculated by summing with scores ranging from 0 - 238. For all scales higher values indicate a higher problem level.
  • Change from baseline children´s self reported psychiatric symptoms at 60 months [ Time Frame: baseline and 60 months ]
    Children´s psychiatric disorders will further be assessed by children´s rating of the German version of the "Youth self report" (YSR; Achenbach, 1991). The German version of the YSR consists of 119 items. Each item has 3 response options, which range from 0 = "not true or seldom true" to 2 = "true or often true". The 8 syndrome scales to be calculated by summing are "social withdrawal" with scores ranging from 0 - 14, "physical discomfort" with scores ranging from 0 - 18, "anxiety/depression" with scores ranging from 0 - 32, "social difficulties" with scores ranging from 0 - 16, "schizoid/compulsive" scores ranging from 0 - 14, "attention deficits" with scores ranging from 0 - 18, "dissocial behavior" with scores ranging from 0 - 22, "aggressive behavior" with scores ranging from 0 - 38 and "other difficulties" with scores ranging from 0 - 40. A total score can be calculated by summing with scores ranging from 0 - 238. For all scales higher values indicate a higher problem level.
  • Change from baseline children´s structural functioning at 12 months [ Time Frame: baseline and 12 months ]
    Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the German structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Goth & Schmeck, 2016). The OPD-KJ2-SF consists of 81 items. Each item has 5 response options, which range from 0 = "no" to 4 = "yes". The 4 higher order scales to be calculated by summing are "self regulation" with scores ranging from 0 - 64, "identity" with scores ranging from 0 - 96, "interpersonality" with scores ranging from 0 - 100 and "attachment" with scores ranging from 0 - 64. A total score can be calculated ba summing with scores ranging from 0 - 342. For all scales higher values indicate a higher structural impairment.
  • Change from baseline children´s structural functioning at 24 months [ Time Frame: baseline and 24 months ]
    Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the German structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Goth & Schmeck, 2017). The OPD-KJ2-SF consists of 81 items. Each item has 5 response options, which range from 0 = "no" to 4 = "yes". The 4 higher order scales to be calculated by summing are "self regulation" with scores ranging from 0 - 64, "identity" with scores ranging from 0 - 96, "interpersonality" with scores ranging from 0 - 100 and "attachment" with scores ranging from 0 - 64. A total score can be calculated ba summing with scores ranging from 0 - 342. For all scales higher values indicate a higher structural impairment.
  • Change from baseline children´s structural functioning at 36 months [ Time Frame: baseline and 36 months ]
    Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the German structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Goth & Schmeck, 2017). The OPD-KJ2-SF consists of 81 items. Each item has 5 response options, which range from 0 = "no" to 4 = "yes". The 4 higher order scales to be calculated by summing are "self regulation" with scores ranging from 0 - 64, "identity" with scores ranging from 0 - 96, "interpersonality" with scores ranging from 0 - 100 and "attachment" with scores ranging from 0 - 64. A total score can be calculated ba summing with scores ranging from 0 - 342. For all scales higher values indicate a higher structural impairment.
  • Change from baseline children´s structural functioning at 48 months [ Time Frame: baseline and 48 months ]
    Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the German structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Goth & Schmeck, 2017). The OPD-KJ2-SF consists of 81 items. Each item has 5 response options, which range from 0 = "no" to 4 = "yes". The 4 higher order scales to be calculated by summing are "self regulation" with scores ranging from 0 - 64, "identity" with scores ranging from 0 - 96, "interpersonality" with scores ranging from 0 - 100 and "attachment" with scores ranging from 0 - 64. A total score can be calculated ba summing with scores ranging from 0 - 342. For all scales higher values indicate a higher structural impairment.
  • Change from baseline children´s structural functioning at 60 months [ Time Frame: baseline and 60 months ]
    Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the German structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Goth & Schmeck, 2017). The OPD-KJ2-SF consists of 81 items. Each item has 5 response options, which range from 0 = "no" to 4 = "yes". The 4 higher order scales to be calculated by summing are "self regulation" with scores ranging from 0 - 64, "identity" with scores ranging from 0 - 96, "interpersonality" with scores ranging from 0 - 100 and "attachment" with scores ranging from 0 - 64. A total score can be calculated ba summing with scores ranging from 0 - 342. For all scales higher values indicate a higher structural impairment.
  • Change from baseline children´s health related quality of life at 12 months [ Time Frame: baseline and 12 months ]
    Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the Kidscreen-27 (Ravens-Sieberer & the European KIDSCREEN group, 2006). The Kidscreen-27 consists of 27 items. Each item is scored on a 5-point Likert scale ranging from 1 = "not at all true/never" to 5 = "extremely/always". The items are summed up for the 5 specific subscales "physical well-being" with scores ranging from 1 - 20, "psychological well-being" with scores ranging from 1 - 35, "autonomy and parent relation" with scores ranging from 1 - 35, "Social support and peers" with scores ranging from 1 - 40 and "school environment" with scores ranging from 1 - 20. High values represent a high quality of life.
  • Change from baseline children´s health related quality of life at 24 months [ Time Frame: baseline and 24 months ]
    Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the Kidscreen-27 (Ravens-Sieberer & the European KIDSCREEN group, 2006). The Kidscreen-27 consists of 27 items. Each item is scored on a 5-point Likert scale ranging from 1 = "not at all true/never" to 5 = "extremely/always". The items are summed up for the 5 specific subscales "physical well-being" with scores ranging from 1 - 20, "psychological well-being" with scores ranging from 1 - 35, "autonomy and parent relation" with scores ranging from 1 - 35, "Social support and peers" with scores ranging from 1 - 40 and "school environment" with scores ranging from 1 - 20. High values represent a high quality of life.
  • Change from baseline children´s health related quality of life at 36 months [ Time Frame: baseline and 36 months ]
    Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the Kidscreen-27 (Ravens-Sieberer & the European KIDSCREEN group, 2006). The Kidscreen-27 consists of 27 items. Each item is scored on a 5-point Likert scale ranging from 1 = "not at all true/never" to 5 = "extremely/always". The items are summed up for the 5 specific subscales "physical well-being" with scores ranging from 1 - 20, "psychological well-being" with scores ranging from 1 - 35, "autonomy and parent relation" with scores ranging from 1 - 35, "Social support and peers" with scores ranging from 1 - 40 and "school environment" with scores ranging from 1 - 20. High values represent a high quality of life.
  • Change from baseline children´s health related quality of life at 48 months [ Time Frame: baseline and 48 months ]
    Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the Kidscreen-27 (Ravens-Sieberer & the European KIDSCREEN group, 2006). The Kidscreen-27 consists of 27 items. Each item is scored on a 5-point Likert scale ranging from 1 = "not at all true/never" to 5 = "extremely/always". The items are summed up for the 5 specific subscales "physical well-being" with scores ranging from 1 - 20, "psychological well-being" with scores ranging from 1 - 35, "autonomy and parent relation" with scores ranging from 1 - 35, "Social support and peers" with scores ranging from 1 - 40 and "school environment" with scores ranging from 1 - 20. High values represent a high quality of life.
  • Change from baseline children´s health related quality of life at 60 months [ Time Frame: baseline and 60 months ]
    Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the German version of the Kidscreen-27 (Ravens-Sieberer & the European KIDSCREEN group, 2006). The Kidscreen-27 consists of 27 items. Each item is scored on a 5-point Likert scale ranging from 1 = "not at all true/never" to 5 = "extremely/always". The items are summed up for the 5 specific subscales "physical well-being" with scores ranging from 1 - 20, "psychological well-being" with scores ranging from 1 - 35, "autonomy and parent relation" with scores ranging from 1 - 35, "Social support and peers" with scores ranging from 1 - 40 and "school environment" with scores ranging from 1 - 20. High values represent a high quality of life.
  • Change from baseline children´s global impairment at 12 months [ Time Frame: baseline and 12 months ]
    Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985). The SGKJ is a 10 point scale which describes a hypothetic continuum from 10 = mental health ("Outstanding functioning in all areas - e.g. at home, in school, with peers") to 1 = mental disorder ("Needs steady supervision because of severe aggressive or self-destructive behavior, impaired reality testing, communication, cognition, affect or hygiene").
  • Change from baseline children´s global impairment at 24 months [ Time Frame: baseline and 24 months ]
    Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985). The SGKJ is a 10 point scale which describes a hypothetic continuum from 10 = mental health ("Outstanding functioning in all areas - e.g. at home, in school, with peers") to 1 = mental disorder ("Needs steady supervision because of severe aggressive or self-destructive behavior, impaired reality testing, communication, cognition, affect or hygiene").
  • Change from baseline children´s global impairment at 36 months [ Time Frame: baseline and 36 months ]
    Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985). The SGKJ is a 10 point scale which describes a hypothetic continuum from 10 = mental health ("Outstanding functioning in all areas - e.g. at home, in school, with peers") to 1 = mental disorder ("Needs steady supervision because of severe aggressive or self-destructive behavior, impaired reality testing, communication, cognition, affect or hygiene").
  • Change from baseline children´s global impairment at 48 months [ Time Frame: baseline and 48 months ]
    Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985). The SGKJ is a 10 point scale which describes a hypothetic continuum from 10 = mental health ("Outstanding functioning in all areas - e.g. at home, in school, with peers") to 1 = mental disorder ("Needs steady supervision because of severe aggressive or self-destructive behavior, impaired reality testing, communication, cognition, affect or hygiene").
  • Change from baseline children´s global impairment at 60 months [ Time Frame: baseline and 60 months ]
    Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985). The SGKJ is a 10 point scale which describes a hypothetic continuum from 10 = mental health ("Outstanding functioning in all areas - e.g. at home, in school, with peers") to 1 = mental disorder ("Needs steady supervision because of severe aggressive or self-destructive behavior, impaired reality testing, communication, cognition, affect or hygiene").
  • Change from baseline relational functioning at 12 months [ Time Frame: baseline and 12 months ]
    Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, & Zaudig, 1996). The GARF is a 100 point continuous scale with anchor items for every 20 points. It assesses the family functioning from 1 -20 = "the system of relationships within the family is extremely disturbed, continuity of contact and attachment can not be kept up any longer" to 80 - 100 = "the system of relationships in the family ist high functioning".
  • Change from baseline relational functioning at 24 months [ Time Frame: baseline and 24 months ]
    Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, & Zaudig, 1996). The GARF is a 100 point continuous scale with anchor items for every 20 points. It assesses the family functioning from 1 -20 = "the system of relationships within the family is extremely disturbed, continuity of contact and attachment can not be kept up any longer" to 80 - 100 = "the system of relationships in the family ist high functioning".
  • Change from baseline relational functioning at 36 months [ Time Frame: baseline and 36 months ]
    Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, & Zaudig, 1996). The GARF is a 100 point continuous scale with anchor items for every 20 points. It assesses the family functioning from 1 -20 = "the system of relationships within the family is extremely disturbed, continuity of contact and attachment can not be kept up any longer" to 80 - 100 = "the system of relationships in the family ist high functioning".
  • Change from baseline relational functioning at 48 months [ Time Frame: baseline and 48 months ]
    Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, & Zaudig, 1996). The GARF is a 100 point continuous scale with anchor items for every 20 points. It assesses the family functioning from 1 -20 = "the system of relationships within the family is extremely disturbed, continuity of contact and attachment can not be kept up any longer" to 80 - 100 = "the system of relationships in the family ist high functioning".
  • Change from baseline relational functioning at 60 months [ Time Frame: baseline and 60 months ]
    Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, & Zaudig, 1996). The GARF is a 100 point continuous scale with anchor items for every 20 points. It assesses the family functioning from 1 -20 = "the system of relationships within the family is extremely disturbed, continuity of contact and attachment can not be kept up any longer" to 80 - 100 = "the system of relationships in the family ist high functioning".
  • Change from baseline children´s global functioning at 12 months [ Time Frame: baseline and 12 months ]
    Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000). The GAF is a 100 point continuous scale with anchor items for every 10 points. Scores between 91 - 100 are given for "Outstanding performance in many activities and coping, no loss of control, being appreciated for many positive qualities, no symptoms". Scores between 1 - 10 are given for "permanent danger of hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal attempt with clear expectation of death".
  • Change from baseline children´s global functioning at 24 months [ Time Frame: baseline and 24 months ]
    Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000). The GAF is a 100 point continuous scale with anchor items for every 10 points. Scores between 91 - 100 are given for "Outstanding performance in many activities and coping, no loss of control, being appreciated for many positive qualities, no symptoms". Scores between 1 - 10 are given for "permanent danger of hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal attempt with clear expectation of death".
  • Change from baseline children´s global functioning at 36 months [ Time Frame: baseline and 36 months ]
    Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000). The GAF is a 100 point continuous scale with anchor items for every 10 points. Scores between 91 - 100 are given for "Outstanding performance in many activities and coping, no loss of control, being appreciated for many positive qualities, no symptoms". Scores between 1 - 10 are given for "permanent danger of hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal attempt with clear expectation of death".
  • Change from baseline children´s global functioning at 48 months [ Time Frame: baseline and 48 months ]
    Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000). The GAF is a 100 point continuous scale with anchor items for every 10 points. Scores between 91 - 100 are given for "Outstanding performance in many activities and coping, no loss of control, being appreciated for many positive qualities, no symptoms". Scores between 1 - 10 are given for "permanent danger of hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal attempt with clear expectation of death".
  • Change from baseline children´s global functioning at 60 months [ Time Frame: baseline and 60 months ]
    Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000). The GAF is a 100 point continuous scale with anchor items for every 10 points. Scores between 91 - 100 are given for "Outstanding performance in many activities and coping, no loss of control, being appreciated for many positive qualities, no symptoms". Scores between 1 - 10 are given for "permanent danger of hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal attempt with clear expectation of death".
  • Change from baseline health economic data at 12 months [ Time Frame: baseline and 12 months ]
    Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian et al., 2009). The CAMHSRI-DE assesses demand (number and duration) of inpatient and outpatient medical services as well as use of medication and demand of special educational establishment or offers in school in the past 12 months.
  • Change from baseline health economic data at 24 months [ Time Frame: baseline and 24 months ]
    Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian et al., 2009). The CAMHSRI-DE assesses demand (number and duration) of inpatient and outpatient medical services as well as use of medication and demand of special educational establishment or offers in school in the past 12 months.
  • Change from baseline health economic data at 36 months [ Time Frame: baseline and 36 months ]
    Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian et al., 2009). The CAMHSRI-DE assesses demand (number and duration) of inpatient and outpatient medical services as well as use of medication and demand of special educational establishment or offers in school in the past 12 months.
  • Change from baseline health economic data at 48 months [ Time Frame: baseline and 48 months ]
    Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian et al., 2009). The CAMHSRI-DE assesses demand (number and duration) of inpatient and outpatient medical services as well as use of medication and demand of special educational establishment or offers in school in the past 12 months.
  • Change from baseline health economic data at 60 months [ Time Frame: baseline and 60 months ]
    Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-DE; Kilian et al., 2009). The CAMHSRI-DE assesses demand (number and duration) of inpatient and outpatient medical services as well as use of medication and demand of special educational establishment or offers in school in the past 12 months.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
  • Change from baseline children´s depressive symptomatology at 12 months [ Time Frame: baseline and 12 months ]
    Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, & Duda, 2000).
  • Change from baseline children´s depressive symptomatology at 24 months [ Time Frame: baseline and 24 months ]
    Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, & Duda, 2000).
  • Change from baseline children´s depressive symptomatology at 36 months [ Time Frame: baseline and 36 months ]
    Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, & Duda, 2000).
  • Change from baseline children´s depressive symptomatology at 48 months [ Time Frame: baseline and 48 months ]
    Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, & Duda, 2000).
  • Change from baseline children´s depressive symptomatology at 60 months [ Time Frame: baseline and 60 months ]
    Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ); Stiensmeier-Pelster, Schürmann, & Duda, 2000).
  • Change from baseline children´s anxiety at 12 months [ Time Frame: baseline and 12 months ]
    Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, & McCanzie, 1995).
  • Change from baseline children´s anxiety at 24 months [ Time Frame: baseline and 24 months ]
    Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, & McCanzie, 1995).
  • Change from baseline children´s anxiety at 36 months [ Time Frame: baseline and 36 months ]
    Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, & McCanzie, 1995).
  • Change from baseline children´s anxiety at 48 months [ Time Frame: baseline and 48 months ]
    Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, & McCanzie, 1995).
  • Change from baseline children´s anxiety at 60 months [ Time Frame: baseline and 60 months ]
    Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully, Brent, & McCanzie, 1995).
  • Change from baseline parent reported children´s psychiatric symptoms at 12 months [ Time Frame: baseline and 12 months ]
    Cildren´s psychiatric disorders will further be assessed by parents´ rating of the german version of the "Child behavior checklist" (CBCL; Achenbach, 1991)
  • Change from baseline parent reported children´s psychiatric symptoms at 24 months [ Time Frame: baseline and 24 months ]
    Cildren´s psychiatric disorders will further be assessed by parents´ rating of the german version of the "Child behavior checklist" (CBCL; Achenbach, 1991)
  • Change from baseline parent reported children´s psychiatric symptoms at 36 months [ Time Frame: baseline and 36 months ]
    Cildren´s psychiatric disorders will further be assessed by parents´ rating of the german version of the "Child behavior checklist" (CBCL; Achenbach, 1991)
  • Change from baseline parent reported children´s psychiatric symptoms at 48 months [ Time Frame: baseline and 48 months ]
    Cildren´s psychiatric disorders will further be assessed by parents´ rating of the german version of the "Child behavior checklist" (CBCL; Achenbach, 1991)
  • Change from baseline parent reported children´s psychiatric symptoms at 60 months [ Time Frame: baseline and 60 months ]
    Cildren´s psychiatric disorders will further be assessed by parents´ rating of the german version of the "Child behavior checklist" (CBCL; Achenbach, 1991)
  • Change from baseline children´s self reported psychiatric symptoms at 12 months [ Time Frame: baseline and 12 months ]
    Cildren´s psychiatric disorders will further be assessed by children´s (aged 10 years and older) rating of the german version of the "Youth self report" (YSR; Achenbach, 1991)
  • Change from baseline children´s self reported psychiatric symptoms at 24 months [ Time Frame: baseline and 24 months ]
    Cildren´s psychiatric disorders will further be assessed by children´s (aged 10 years and older) rating of the german version of the "Youth self report" (YSR; Achenbach, 1991)
  • Change from baseline children´s self reported psychiatric symptoms at 36 months [ Time Frame: baseline and 36 months ]
    Cildren´s psychiatric disorders will further be assessed by children´s (aged 10 years and older) rating of the german version of the "Youth self report" (YSR; Achenbach, 1991)
  • Change from baseline children´s self reported psychiatric symptoms at 48 months [ Time Frame: baseline and 48 months ]
    Cildren´s psychiatric disorders will further be assessed by children´s (aged 10 years and older) rating of the german version of the "Youth self report" (YSR; Achenbach, 1991)
  • Change from baseline children´s self reported psychiatric symptoms at 60 months [ Time Frame: baseline and 60 months ]
    Cildren´s psychiatric disorders will further be assessed by children´s (aged 10 years and older) rating of the german version of the "Youth self report" (YSR; Achenbach, 1991)
  • Change from beaseline children´s structural functioning at 12 months [ Time Frame: baseline and 12 months ]
    Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the german structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Schrobildgen et al., 2017)
  • Change from beaseline children´s structural functioning at 24 months [ Time Frame: baseline and 24 months ]
    Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the german structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Schrobildgen et al., 2017)
  • Change from beaseline children´s structural functioning at 36 months [ Time Frame: baseline and 36 months ]
    Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the german structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Schrobildgen et al., 2017)
  • Change from beaseline children´s structural functioning at 48 months [ Time Frame: baseline and 48 months ]
    Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the german structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Schrobildgen et al., 2017)
  • Change from beaseline children´s structural functioning at 60 months [ Time Frame: baseline and 60 months ]
    Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older) using the german structure questionnaire for the "Operationalized psychodynamic diagnostic for children and adolescents" (OPD-KJ2-SF, Schrobildgen et al., 2017)
  • Change from baseline children´s health related quality of life at 12 months [ Time Frame: baseline and 12 months ]
    Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the Kidscreen (Ravens-Sieberer & the European KIDSCREEN group, 2006).
  • Change from baseline children´s health related quality of life at 24 months [ Time Frame: baseline and 24 months ]
    Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the Kidscreen (Ravens-Sieberer & the European KIDSCREEN group, 2006).
  • Change from baseline children´s health related quality of life at 36 months [ Time Frame: baseline and 36 months ]
    Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the Kidscreen (Ravens-Sieberer & the European KIDSCREEN group, 2006).
  • Change from baseline children´s health related quality of life at 48 months [ Time Frame: baseline and 48 months ]
    Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the Kidscreen (Ravens-Sieberer & the European KIDSCREEN group, 2006).
  • Change from baseline children´s health related quality of life at 60 months [ Time Frame: baseline and 60 months ]
    Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of the german version of the Kidscreen (Ravens-Sieberer & the European KIDSCREEN group, 2006).
  • Change from baseline children´s global impairment at 12 months [ Time Frame: baseline and 12 months ]
    Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985).
  • Change from baseline children´s global impairment at 24 months [ Time Frame: baseline and 24 months ]
    Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985).
  • Change from baseline children´s global impairment at 36 months [ Time Frame: baseline and 36 months ]
    Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985).
  • Change from baseline children´s global impairment at 48 months [ Time Frame: baseline and 48 months ]
    Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985).
  • Change from baseline children´s global impairment at 60 months [ Time Frame: baseline and 60 months ]
    Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985).
  • Change from baseline relational functioning at 12 months [ Time Frame: baseline and 12 months ]
    Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, & Zaudig, 1996).
  • Change from baseline relational functioning at 24 months [ Time Frame: baseline and 24 months ]
    Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, & Zaudig, 1996).
  • Change from baseline relational functioning at 36 months [ Time Frame: baseline and 36 months ]
    Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, & Zaudig, 1996).
  • Change from baseline relational functioning at 48 months [ Time Frame: baseline and 48 months ]
    Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, & Zaudig, 1996).
  • Change from baseline relational functioning at 60 months [ Time Frame: baseline and 60 months ]
    Families´ relational functioning will be rated by a trained rater external to the project using the german version of the "Global assessment of relational functioning scale" (GARF; Saß, Wittchen, & Zaudig, 1996).
  • Change from baseline children´s global functioning at 12 months [ Time Frame: baseline and 12 months ]
    Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000).
  • Change from baseline children´s global functioning at 24 months [ Time Frame: baseline and 24 months ]
    Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000).
  • Change from baseline children´s global functioning at 36 months [ Time Frame: baseline and 36 months ]
    Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000).
  • Change from baseline children´s global functioning at 48 months [ Time Frame: baseline and 48 months ]
    Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000).
  • Change from baseline children´s global functioning at 60 months [ Time Frame: baseline and 60 months ]
    Children´s global functioning will be rated by a trained rater external to the project using the german version of the "Global assessment functioning scale" (GAF; American Psychiatric Association, 2000).
  • Change from baseline health economic data at 12 months [ Time Frame: baseline and 12 months ]
    Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-EU; Kilian et al., 2009).
  • Change from baseline health economic data at 24 months [ Time Frame: baseline and 24 months ]
    Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-EU; Kilian et al., 2009).
  • Change from baseline health economic data at 36 months [ Time Frame: baseline and 36 months ]
    Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-EU; Kilian et al., 2009).
  • Change from baseline health economic data at 48 months [ Time Frame: baseline and 48 months ]
    Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-EU; Kilian et al., 2009).
  • Change from baseline health economic data at 60 months [ Time Frame: baseline and 60 months ]
    Health economics will be assessed by a trained rater external to the project using the german version of the "Children and adolescent mental health services receipt inventory" (CAMHSRI-EU; Kilian et al., 2009).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short-term, Long-term and Cost-effectiveness of Treating Depression and Anxiety Disorders in Children and Adolescents
Official Title  ICMJE Short-term, Long-term and Cost-effectiveness of Treating Depression and Anxiety Disorders in Children and Adolescents - a Randomized Controlled Trial
Brief Summary The current study will evaluate and compare the effectiveness of cognitive-behavioral and psychodynamic therapy. Therefore 420 children and adolescents (ages 8-16 years) with depression and/or anxiety disorder will be randomly assigned to a treatment or a control condition. The intervention´s short-term effectiveness and sustainability as well as cost-effectiveness will be examined over a 5 year period for each participant.
Detailed Description

This study aims to optimize patient-centered care and to ensure scientific and legal approval of cognitive-behavioral and psychodynamic therapy for children and adolescents in the German health-care system. This prospective, randomized and controlled trial will therefore compare psychodynamic and cognitive behavioral therapy with a low-frequency family intervention (control intervention) for children and adolescents with depression and anxiety disorder. Number of diagnoses or fulfilled diagnostic criteria - diagnosed by a trained psychologist who is blind for treatment condition - will be the primary outcome. Secondary outcomes are patients´ and parents´ strain caused by symptoms, patients´ quality of life, global and family functioning and treatments´ cost effectiveness are secondary outcomes.

Patients will be recruited at the end of an inpatient hospital stay in northern Germany (Hamburg and Bremen) in two clinics for child and adolescent psychiatry and in surgery. After gathering informed consent from parents and patients, the latter will be randomly assigned to one type of outpatient treatment (psychodynamic, cognitive behavioral therapy or family intervention). Psychodynamic and cognitive-behavioral therapy as well as the control intervention will be provided manual-based. Treatment sessions will be audio recorded to control adherence.

Data will be collected annually over a period of five years starting at the beginning of treatment. This allows examination of varying treatment intervals as well as the sustainability and health economics of therapy effects.

To analyze data, comparisons of means will be performed. Groupwise analyses of interaction will be performed for inferential testing of differences in subgroups. Differences in therapy effects will be inferentially analyzed by multifactor analysis of covariance, analysis of variance or logistic regression. Interaction effects and predicting variables are of special interest.

In a Subsample of 32 depressive adolescents (ages 13-16) patients expectations before and experiences whilst therapy will be analyzed by a mixed-methods-approach.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression, Anxiety
Intervention  ICMJE
  • Behavioral: psychodynamic psychotherapy
    the intervention follows the published in german manual: Psychoanalytische Behandlung von Kindern und Jugendlichen mit Angststörungen und Depressionen: Behandlungsmanual (Baumeister-Duru, Hofmann, Timmermann & Wulf, 2013)
  • Behavioral: cognitive behavioral psychotherapy
    the interventions follow the published in german manuals: Depression (Ihle, Groen, Walter, Esser, & Petermann, 2012) and Soziale Ängste und Leistungsängste (Büch, Döpfner, & Petermann, 2015)
  • Behavioral: psychodynamic family intervention
    the intervention follows an adapted version of the manual: Chimp´s - Children of mentally ill parents (Wiegand-Gefe, Halverscheid, & Plass, 2011)
Study Arms  ICMJE
  • Experimental: psychodynamic psychotherapy
    Intervention: Behavioral: psychodynamic psychotherapy
  • Experimental: cognitive behavioral psychotherapy
    Intervention: Behavioral: cognitive behavioral psychotherapy
  • Active Comparator: psychodynamic family intervention
    Intervention: Behavioral: psychodynamic family intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2017)
420
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosis of a depressive disorder (ICD-10; F30-F39) or an anxiety disorder (ICD-10; F40-F42)
  • informed consent
  • ages 8 to 16 years

Exclusion Criteria:

  • psychotic disorders, eating disorders, substance use related disorders (except caffeine and nicotine), autism spectrum disorders, mutism, personality disorders
  • neurologic disorders
  • severe mental retardation (filling out questionnaires and interview are not feasible)
  • low command of the german language
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Silke Wiegand-Grefe, Prof. Dr. +49-40-741053603 s.wiegand-grefe@uke.de
Contact: Antje Masemann, M. Sc. +49-40-741052633 a.masemann@uke.de
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03333239
Other Study ID Numbers  ICMJE vakjp_2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Silke Wiegand-Grefe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE University of Bremen
Investigators  ICMJE
Principal Investigator: Silke Wiegand-Grefe, Prof. Dr. UKE Universitätsklinikum Hamburg-Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP