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PRimary Prevention Of Depression in Offspring of Depressed Parents (PRODO)

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ClinicalTrials.gov Identifier: NCT02115880
Recruitment Status : Unknown
Verified May 2014 by Professor Gerd Schulte-Körne, Ludwig-Maximilians - University of Munich.
Recruitment status was:  Recruiting
First Posted : April 16, 2014
Last Update Posted : May 28, 2014
Sponsor:
Collaborator:
Bavarian State Ministry of Environment, Public Health and Consumer Protection
Information provided by (Responsible Party):
Professor Gerd Schulte-Körne, Ludwig-Maximilians - University of Munich

Brief Summary:
The purpose of this randomised controlled trial is to see whether a group-based psychological intervention for families can reduce the inflated risk of depression in children and adolescents who have at least one parent who suffers from depression (or who has suffered from depressed in the child's lifetime).

Condition or disease Intervention/treatment Phase
Depression Behavioral: Prevention programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PRimary Prevention Of Depression in Offspring of Depressed Parents
Study Start Date : May 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prevention programme Behavioral: Prevention programme
Based on a group- and family-based cognitive behavioural manual developed by Bruce Compas and colleagues in the USA, and adapted for a German sample. The programme is for parents and children and consists of 8 weekly sessions and 4 monthly booster sessions.

No Intervention: Control (treatment as usual)



Primary Outcome Measures :
  1. Presence or absence of a depressive episode (child) [ Time Frame: T4 (9 months after completion of the programme) ]
    The German version of the Diagnostic Interview for Psychiatric Disorders in Children and Adolescents (Kinder DIPS) will be used to assess whether the child meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for a depressive episode.


Secondary Outcome Measures :
  1. Symptoms of depression (child) [ Time Frame: Within 2 weeks of the last session of the intervention (T2) as well as 3 months after the intervention (T3) and 9 months after the intervention (T4) ]
    Self-reported symptoms of depression will be collected using the German questionnaires "Depression Inventory for Children and Adolescents" (DIKJ) and Beck Depression Inventory (BDI-II; depending on the child's age).

  2. Psychopathological symptoms (child) [ Time Frame: Within 2 weeks of the last session of the intervention (T2) as well as 3 months after the intervention (T3) and 9 months after the intervention (T4) ]
    More general internal and external psychopathological symptoms will be measured using German versions of the questionnaires "Youth Self-Report" (YSR; child self-report) and "Child Behaviour Checklist" (CBCL; parent-report).



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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least one parent who meets diagnostic criteria for a current (or past, during the child's lifetime) diagnosis of depression
  • The participating child is aged 8-17
  • The participating child has an IQ of at least 85
  • Both child and parent(s) have adequate German-language skills
  • Both child and parents consent to intervention sessions being video-recorded

Exclusion Criteria:

  • The participating parent(s) has current symptoms of bipolar disorder, psychotic symptoms, personality disorder, substance addiction, or is suicidal
  • The participating child meets criteria for a current, or previous, episode of any psychiatric disorder
  • The participating child is undergoing or has undergone treatment for depression
  • The participating child or parent have serious symptoms of a disorder (or are in crisis) that may hamper their ability to take part in the study

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): NCT02115880


Contacts
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Contact: Belinda J Platt, DPhil. +498945229032 belinda.platt@med.uni-muenchen.de

Locations
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Germany
Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy Recruiting
Munich, Bavaria, Germany, 80336
Contact: Belinda J Platt, DPhil.    +498945229032    belinda.platt@med.uni-muenchen.de   
Sub-Investigator: Belinda J Platt, DPhil.         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Bavarian State Ministry of Environment, Public Health and Consumer Protection
Investigators
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Principal Investigator: Gerd Schulte-Körne, MD Ludwig-Maximilians - University of Munich

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Gerd Schulte-Körne, Prof. Dr., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT02115880     History of Changes
Other Study ID Numbers: LP00216_PRODO
LP00216 ( Other Grant/Funding Number: Bavarian State Ministry of Environment, Public Health and Consumer Protection )
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by Professor Gerd Schulte-Körne, Ludwig-Maximilians - University of Munich:
Depression
Prevention
Adolescent
Child
Randomised Controlled Trial
Risk
Cognitive behavioural therapy
Group-based therapy

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders