PRimary Prevention Of Depression in Offspring of Depressed Parents

Study Overview
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Brief Summary
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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).

Official Title
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PRimary Prevention Of Depression in Offspring of Depressed Parents

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Prevention programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention programme<br> | Behavioral: Prevention programme<br>* 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.<br>|
| No Intervention: Control (treatment as usual)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of a depressive episode (child) | 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. | T4 (9 months after completion of the programme) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of depression (child) | 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). | 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) | 
| Psychopathological symptoms (child) | 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). | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Prevention, Adolescent, Child, Randomised Controlled Trial, Risk, Cognitive behavioural therapy, Group-based therapy