A Family Depression Prevention Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-01

Study Completion Date

2023-12-31

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.

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Interviewers who assess diagnostic outcomes are masked to participant condition.

Study Groups

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Family Cognitive Behavioral Prevention

A family cognitive behavioral program for parents and children. Parents learn parenting skills and cognitive behavioral techniques for managing depression. Children learn coping skills.

Group Type EXPERIMENTAL

Family Cognitive Behavioral Prevention

Intervention Type BEHAVIORAL

Parent training and cognitive behavioral intervention with parents. Coping skills training with children.

Written Information

Families receive written materials about depression and the effects of parental depression on children.

Group Type ACTIVE_COMPARATOR

Written information

Intervention Type BEHAVIORAL

Reading materials about depression

Interventions

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Family Cognitive Behavioral Prevention

Parent training and cognitive behavioral intervention with parents. Coping skills training with children.

Intervention Type BEHAVIORAL

Written information

Reading materials about depression

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive behavioral intervention Coping skills training Parent training Psychoeducation Self-help

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)

Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No