A Family Depression Prevention Program

Study Overview
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Brief Summary
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The primary aim is to prevent depression in youth and parents in a single, integrated family intervention. Hypothesis 1a: Children in the Family Depression Prevention (FDP) program will have significantly lower levels of anxious/depressive symptoms and fewer onsets of depressive episodes as compared to children in the Written Information (WI) condition. Hypothesis 1b: In parents, the amount of time in a depressive episode will be significantly lower for those in the FDP program as compared to those in the WI condition.

Detailed Description
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Depression is a major public health problem affecting over 15 million U.S. adults annually and is especially prevalent in those of parenting age. Offspring of depressed parents are at increased risk of depression and therefore are a critical target for preventive interventions. The current study aims to reduce the rate of depression in parents and their children by adopting an innovative, family-based approach to simultaneously preventing depression in at-risk youth and in their affected parents. The rationale for this approach is based on (a) a conceptual model that integrates parenting processes, stress (particularly that which is associated with parental depression), and children's self-regulatory skills in the face of stress, (b) evidence that depression runs in families, (c) promising results from family- and child-focused depression prevention programs, (d) evidence that in adults, cognitive-behavioral therapy (CBT) reduces both depressive episodes and their recurrence, and (e) growing consensus among scientists, clinicians, and policymakers on the need for family-based models of healthcare. This 5- year, two-site randomized controlled trial will test a Family Depression Prevention (FDP) program for children (ages 9-15) and their parents with depressive disorders (past or current). This dual prevention approach is a novel synthesis of existing evidence-based intervention techniques drawn from child prevention and adult treatment models. Participating families (N=300) will be randomized to either FDP (10 weekly + 3 monthly sessions) or a written information comparison (WI) condition. All parents and children will be evaluated at pre- and post-intervention, and at 6-, 12-months from baseline.

Official Title
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Family Cognitive Behavioral Prevention of Depression in Youth and Parents

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Family Cognitive Behavioral Prevention
* Behavioral: Written information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent with a current or history of a depressive disorder within child's life Children ages 9- to 15-years-old Exclusion Criteria: Bipolar I (parent or child) Schizophrenia (parent or child) Current alcohol or drug abuse (parent or child) Conduct disorder; developmental disability (child) Current diagnosis of a depressive disorder (child)

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Family Cognitive Behavioral Prevention<br>A family cognitive behavioral program for parents and children. Parents learn parenting skills and cognitive behavioral techniques for managing depression. Children learn coping skills. | Behavioral: Family Cognitive Behavioral Prevention<br>* Parent training and cognitive behavioral intervention with parents. Coping skills training with children.<br>* Other names: Parent training;|
| Active Comparator: Written Information<br>Families receive written materials about depression and the effects of parental depression on children. | Behavioral: Written information<br>* Reading materials about depression<br>* Other names: Self-help;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In children, the primary outcome is level of symptoms on the Youth Self-report form. | For child participants, we will assess change in their levels of symptoms on the Youth Self-report form at 12-month follow-up. T-scores range from 0 to 100; higher scores indicate more symptoms (i.e., worse outcome). | twelve months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In children, level of internalizing and externalizing symptoms on the Child Behavior Checklist completed by parent about the child | For child participants, we will assess change in their levels of symptoms on the Child Behavior checklist at 12-month follow-up. | 12 months | 
| Parents: Patient Health Questionnaire - 9 (PHQ-9) | Parent participants: The PHQ-9 measures 9 symptoms of depression on a 4-point scale. Scores can range from 0 to 36. | 12 months | 
| Children: depressive diagnoses | Children and parents are interviewed about the child's depressive symptoms with the Longitudinal Interval Follow-up Evaluation, which yields scores 1-6 for each week. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Mood disorder