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Implementation and Evaluation of a Family-based Intervention Program for Children of Mentally Ill Parents (CHIMPs)

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ClinicalTrials.gov Identifier: NCT02308462
Recruitment Status : Active, not recruiting
First Posted : December 4, 2014
Last Update Posted : September 12, 2018
Sponsor:
Collaborators:
Universitätsklinikum Hamburg-Eppendorf
University of Ulm
Universitätsklinikum Leipzig
LWL-Klinikum Gütersloh
Vitos Klinik Rheinhöhe
Charite University, Berlin, Germany
Cantonal Hospital Winterthur, Switzerland
Information provided by (Responsible Party):
Silke Wiegand-Grefe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
In order to identify psychological stress in children and adolescents of mentally ill parents as early as possible, a special intervention program (CHIMPs = Children of mentally ill parents) was developed. The study at hand will implement this intervention program at five sites in Germany and will further evaluate its effectiveness. The CHIMPs intervention is assumed to reduce children's psychopathology and enhance their health related quality of life.

Condition or disease Intervention/treatment Phase
Schizophrenia and Disorders With Psychotic Features Mood Disorders Neurotic Disorders Personality Disorders Substance-Related Disorders Behavioral: CHIMPS intervention Not Applicable

Detailed Description:

The main purpose of this study is to implement the manualized family intervention CHIMPs (Children of mentally ill parents) for children and adolescents of psychiatrically ill parents aged between 3 and 19 years at the seven participating centres in regular care. The intervention aims at reducing children's psychopathology and enhancing their quality of life in a sustainable way and, moreover, aims at introducing especially remarkable children and adolescents to an early intervention.

The study represents a prospective, randomized and controlled multicenter study (RCT), contrasting one intervention group and one control group (TAU = Treatment as usual) by measurements at baseline and after six, 12 and 18 months. Within the data collection, the perspective of the psychiatrically ill parent, the partner, each child and the therapist will be considered. Children between 3 and 9 years of age will be evaluated only by the parents and the therapist, from 10 years on, an additional self-report form will be filled out by the child. The measurement will be ruled out indirectly (for the pre-post-measurement) as well as directly (at the end of treatment).

For each endpoint, one comprehensive mixed model will be fitted to the data containing the baseline value and further relevant patient characteristics as covariates, the random group as factor and cluster (center, therapy group, family) as random effect. Missing values will be treated by direct imputation to allow an intention-to-treat analysis.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation and Evaluation of a Family-based Intervention Program for Children and Adolescents of Mentally Ill Parents - a Randomized Controlled Multicenter Trial
Study Start Date : November 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CHIMPs intervention
Family-Intervention
Behavioral: CHIMPS intervention

CHIMPs intervention (Family-Intervention composed of 8 Topic-related sessions over a period of 6 month, based on the evaluated manual: a preliminary talk with the family, two sessions with the parents, one session with each child, three sessions with the family).

The sessions are semi-structured and cover the topics illness and coping, education, family relationships and trusting attachement figures, social network and support of the Family. A detailed description of the procedure is found in the Manual (Wiegand-Grefe, Halverscheid & Plass, 2011).


No Intervention: Control

The long-term effectiveness of the CHIMPs intervention under conditions of practice will be examined in comparison to a control condition receiving the usual after care (Treatment as usual = TAU); this testing of effectiveness will be performed in due consideration of the health economic aspects.

The treatment as usual implies that families of the control Group receive the Treatment that is customary in regular care. Thus, these families normally don't receive any post-treatment. If, however, a member of a control group family appears to have an urgent need for treatment (every Family receives a comprehensive diagnostic investigation at the beginning of the study), the respective family will be placed in the ambulatory care system.




Primary Outcome Measures :
  1. children's psychiatric symptomatology (Kiddie-SADS interview) [ Time Frame: at the beginning of the study (on study enrolment) ]
    Children's psychiatric symptomatology will be assessed, in both groups (Intervention group 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 (observer-blind rater).

  2. children's psychiatric symptomatology (Child behaviour checklist) [ Time Frame: at the beginning of the study (on study enrolment) ]
    The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),

  3. children's psychiatric symptomatology (assessed by Youth Self Report) [ Time Frame: at the beginning of the study (on study enrolment) ]
    The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)

  4. children's psychiatric symptomatology (assessed by the SGKJ) [ Time Frame: at the beginning of the study (on study enrolment) ]
    The psychiatric disorders of the children will further be assessed by the SGKJ ("Skala zur Gesamtbeurteilung von Kindern und Jugendlichen", a scale for the overall assessment of children and adolescents, Steinhausen, 1985).

  5. children's psychiatric symptomatology (Kiddie-SADS interview) [ Time Frame: after the treatment (after 6 months) ]
    Children's psychiatric symptomatology will be assessed, in both groups (Intervention group 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 (observer-blind rater).

  6. children's psychiatric symptomatology (Kiddie-SADS interview) [ Time Frame: after the follow-up period (after 18 months) ]
    Children's psychiatric symptomatology will be assessed, in both groups (Intervention group 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 (observer-blind rater).

  7. children's psychiatric symptomatology (Child behaviour checklist) [ Time Frame: after the treatment (after 6 months) ]
    The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),

  8. children's psychiatric symptomatology (Child behaviour checklist) [ Time Frame: after the follow-up period (after 18 months) ]
    The psychiatric disorders of the children will further be assessed by the CBCL ("Child behaviour checklist", Achenbach, 1991),

  9. children's psychiatric symptomatology (assessed by Youth Self Report) [ Time Frame: after the treatment (after 6 months) ]
    The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)

  10. children's psychiatric symptomatology (assessed by Youth Self Report) [ Time Frame: after the follow-up period (after 18 months) ]
    The psychiatric disorders of the children will further be assessed by the YSR ("Youth self Report", Achenbach, 1991)

  11. children's psychiatric symptomatology (assessed by the SGKJ) [ Time Frame: after the treatment (after 6 months) ]
    The psychiatric disorders of the children will further be assessed by the SGKJ ("Skala zur Gesamtbeurteilung von Kindern und Jugendlichen", a scale for the overall assessment of children and adolescents, Steinhausen, 1985).

  12. children's psychiatric symptomatology (assessed by the SGKJ) [ Time Frame: after the follow-up period (after 18 months) ]
    The psychiatric disorders of the children will further be assessed by the SGKJ ("Skala zur Gesamtbeurteilung von Kindern und Jugendlichen", a scale for the overall assessment of children and adolescents, Steinhausen, 1985).


Secondary Outcome Measures :
  1. children's health related quality of life (Kidscreen) [ Time Frame: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) ]
    Kidscreen (Ravens-Sieberer et al., 2006)

  2. parents' health related quality of life (EQ-5D) [ Time Frame: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) ]
    EQ-5D (Brooks, Rabon & de Charro, 2003; Hinz, Klaiberg, Brähler & König, 2006)

  3. Symptomatology of the parents (Brief Symptom Inventory) [ Time Frame: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) ]
    Brief Symptom Inventory (Franke, 2000)

  4. Symptomatology of the parents (only Intervention group) (SKID; a structured clinical interview for DSM-IV) [ Time Frame: during CHIMPs intervention ]
    Strukturiertes Klinisches Interview für DSM-IV (SKID; a structured clinical interview for DSM-IV, Wittchen, Zaudig & Fydrich, 1997)

  5. parents' coping with the disorder (Freiburger Fragebogen zur Krankheitsbewältigung) [ Time Frame: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) ]
    Freiburger Fragebogen zur Krankheitsbewältigung (FKV; Muthny, 1989)

  6. family relations (children and parents) (Allgemeiner Familienfragebogen) [ Time Frame: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) ]
    Allgemeiner Familienfragebogen (FB-A;Cierpka & Frevert, 1995)

  7. Social Support (Oslo Social Support Questionnaire) [ Time Frame: at the beginning (on study enrolment) and at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) ]
    Oslo Social Support Questionnaire (OSSQ; Dalgaard, 1996)

  8. Objectives of the treatment (children and parents) [ Time Frame: at the beginning of the study (on study enrolment) ]
    Objective of the treatment, assessed by the item "What could be the main objective of a possible treatment?"

  9. achievement of the objectives of the treatment (children and parents) [ Time Frame: at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) ]
    achievement of the objectives of the treatment, assessed by the item "Did you achieve the main objective of your treatment?" and by the item "Taken as a whole, did the family sessions help you?"

  10. Evaluation of the Treatment (children and parents) (Fragebogen zur Beurteilung der Behandlung) [ Time Frame: at the end of the intervention (after 6 months) as well as after the follow-up period (after 18 months) ]
    Fragebogen zur Beurteilung der Behandlung (FBB; Mattejat & Remschmidt, 1999)

  11. health economic assessment of treatment costs (children) (German version of the "Children and adolescent mental health Services receipt inventory) [ Time Frame: at the beginning (on study enrolment), at the end of treatment (after 6 months), after 12 months and after the follow-up period (after 18 months) ]
    German version of the Children and adolescent mental health Services receipt inventory" (CAMHSRI; Kilian et al., 2009)

  12. health economic assessment of treatment costs (parents) (German version of the Client Socioeconomic and Services Receipt Inventory) [ Time Frame: at the beginning (on study enrolment), at the end of treatment (after 6 months), after 12 months and after the follow-up period (after 18 months) ]
    German version of the "Client Socioeconomic and Services Receipt Inventory" (CSSRI; Roick et al., 2001)

  13. Symptomatology of the parents [ Time Frame: at the beginning (on study enrolment) ]
    German version of the "Patient Health Questionnaire" (PHQ; Löwe, Spitzer, Zipfel & Herzog, 2002)



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Family with at least one psychiatrically ill parent and at least one child between the age of 3 and 19 years
  • Consent to participate in the study
  • Sufficient knowledge of the German language of parents and children

Exclusion Criteria:

  • Severe psychiatric disorders and impairments with acute symptoms such as suicidal tendencies, massive self-injurious behaviour, acute psychotic symptoms etc., making a stationary treatment inevitable and making a ambulatory intervention appear contraindicated (These patients are placed in stationary treatment)
  • Children with severe symptoms in the control group will be placed at a participating psychotherapist. Nevertheless, they stay in the control group (as TAU).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308462


Locations
Germany
Charité Campus Virchow Klinikum, Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
Berlin, Germany
Vitos psychiatrische Ambulanz Eltville
Eltville, Germany
Bezirkskrankenhaus Günzburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik
Günzburg, Germany
LWL-Klinikum Gütersloh, Klinik für Allgemeine Psychiatrie und Psychotherapie
Gütersloh, Germany
Asklepios Klinikum Harburg
Hamburg-Harburg, Germany
Schön Klinik Hamburg Eilbek, Abteilung für Psychiatrie und Psychotherapie
Hamburg, Germany
University Medical Center Hamburg-Eppendorf, Clinic and Polyclinic for psychiatry and psychotherapy
Hamburg, Germany
Vitos psychiatrische Ambulanzen Idstein
Idstein, Germany
Universitätsklinikum Leipzig, Klinik für Psychiatrie, Psychotherapie und Psychosomatik des Kindes- und Jugendalters
Leipzig, Germany
Universitätsklinkum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Leipzig, Germany
LWL-Klinik Paderborn, Allgemeine Psychiatrie und Psychotherapie
Paderborn, Germany
Klinik für Psychiatrie und Psychotherapie des Sächsischen Krankenhauses Altscherbitz
Schkeuditz, Germany
Vitos psychiatrische Tageskliniken Wiesbaden
Wiesbaden, Germany
Switzerland
Centre of Social Pediatrics, Dept. of Pediatrics and Adolescent Medicine
Winterthur, Switzerland
Sponsors and Collaborators
Silke Wiegand-Grefe, Prof. Dr.
Universitätsklinikum Hamburg-Eppendorf
University of Ulm
Universitätsklinikum Leipzig
LWL-Klinikum Gütersloh
Vitos Klinik Rheinhöhe
Charite University, Berlin, Germany
Cantonal Hospital Winterthur, Switzerland
Investigators
Principal Investigator: Silke Wiegand-Grefe, Prof. Universitätsklinikum Hamburg-Eppendorf

Publications:
Jeske J, Bullinger M, Wiegand-Grefe S. Do attachement Patterns of parents with a mental illness have an Impact upon how they view the Quality of life of their children? Vulnerable Children and Youth Studies 6(1): 39-50, 2011.
Wiegand-Grefe S, Werkmeister S, Bullinger M, Plass A, Petermann F. [Health-related quality of life and social support of children with mentally ill parents: Effects of a manualized family intervention]. Kindheit und Entwicklung 21 (1): 64-73, 2012.
Jeske J, Bullinger M, Plass A, Petermann F, Wiegand-Grefe S. [Risk factor coping with a disease: Associations between coping an health related quality of life of children with a mentally ill parent]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 57 (3): 207-213, 2009.
Jeske J, Bullinger M, Wiegand-Grefe S. [Families with mentally ill parents - Connections between Family functioning and health-related life quality of children]. Familiendynamik 35 (4): 338-347, 2010.
Wiegand-Grefe S, Halverscheid S, Geers P, Petermann F, Plass A. [Children of mentally ill parents: The relationship between coping with a parental mental illness and children's mental health]. Zeitschrift für Klinische Psychologie und Psychotherapie 39 (1): 13-23, 2010.
Wiegand-Grefe S, Jeske J, Bullinger M, Plass A, Petermann F. [Quality of life of children with psychiatrically ill parents: Relationship between characteristics of parental disorder and health-related quality of life of the children estimated by the parents]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 58 (4): 315-322, 2010.
Wiegand-Grefe S, Cronemeyer B, Plass A, Schulte-Markwort M, Petermann F. [Comparison of mental abnormalities in children of mentally ill parents from different points of view: Effects of a manualized family intervention]. Kindheit und Entwicklung 22 (1): 31-40, 2013.
Wiegand-Grefe S, Cronemeyer B, Halverscheid S, Redlich A, Petermann F. [Coping strategies of psychiatrically ill parents and psychological abnormalities of their children through the focus of a manualized family intervention]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie 61 (1): 51-58, 2013.

Responsible Party: Silke Wiegand-Grefe, Prof. Dr., Professor of clinical psychology, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02308462     History of Changes
Other Study ID Numbers: O1GY1337
U1111-1162-2635 ( Other Identifier: World Health Organization (Universal Trial Number) )
DRKS00006806 ( Registry Identifier: German Clinical Trials Register (DRKS) )
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Silke Wiegand-Grefe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf:
children of mentally ill parents
family intervention
randomized controlled trial

Additional relevant MeSH terms:
Disease
Schizophrenia
Mood Disorders
Personality Disorders
Substance-Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Neurotic Disorders
Pathologic Processes
Mental Disorders
Chemically-Induced Disorders
Anxiety Disorders