A Family Depression Prevention Program

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Family Cognitive Behavioral Prevention; Behavioral: Written information

• Registration Number: NCT02021578
• Lead Sponsor: Vanderbilt University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Study Start: 2014-08-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family Cognitive Behavioral Prevention	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.
Written Information	Written information	Families receive written materials about depression and the effects of parental depression on children.

Primary Outcome Measures

Name	Time	Method
In children, the primary outcome is level of symptoms on the Youth Self-report form.	twelve months post baseline	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).

Secondary Outcome Measures

Name	Time	Method
In children, level of internalizing and externalizing symptoms on the Child Behavior Checklist completed by parent about the child	12 months	For child participants, we will assess change in their levels of symptoms on the Child Behavior checklist at 12-month follow-up.
Parents: Patient Health Questionnaire - 9 (PHQ-9)	12 months	Parent participants: The PHQ-9 measures 9 symptoms of depression on a 4-point scale. Scores can range from 0 to 36.
Children: depressive diagnoses	12 months	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.

Trial Locations

Locations (2)

San Diego State University; 🇺🇸 San Diego, California, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States