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
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Prevention programme||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|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)|
- 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.
- 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).
- 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).
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
|Contact: Belinda J Platt, DPhil.||+email@example.com|
|Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy||Recruiting|
|Munich, Bavaria, Germany, 80336|
|Contact: Belinda J Platt, DPhil. +498945229032 firstname.lastname@example.org|
|Sub-Investigator: Belinda J Platt, DPhil.|
|Principal Investigator:||Gerd Schulte-Körne, MD||Ludwig-Maximilians - University of Munich|