A Family Depression Prevention Program (FDP)

January 30, 2024 updated by: Judith Garber, Vanderbilt University

Family Cognitive Behavioral Prevention of Depression in Youth and Parents

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120-4913
        • San Diego State University
    • Tennessee
      • Nashville, Tennessee, United States, 37203-5721
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 15 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Family Cognitive Behavioral Prevention
Parent training and cognitive behavioral intervention with parents. Coping skills training with children.
Other Names:
  • Parent training
  • Cognitive behavioral intervention
  • Coping skills training
Active Comparator: Written Information
Families receive written materials about depression and the effects of parental depression on children.
Behavioral: Written information
Reading materials about depression
Other Names:
  • Psychoeducation
  • Self-help

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In children, the primary outcome is level of symptoms on the Youth Self-report form.
Time Frame: 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).
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
Time Frame: 12 months
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)
Time Frame: 12 months
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
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

San Diego State University

Investigators

  • Principal Investigator: Bruce Compas, PhD, Vanderbilt University
  • Principal Investigator: Robin Weersing, PhD, San Diego State University
  • Principal Investigator: Judy Garber, PhD, Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimated)

December 27, 2013

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8482529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data reported in publications will be made available to researchers upon request.

IPD Sharing Time Frame

Data will be available after publication of results.

IPD Sharing Access Criteria

Written requests for specific data, hypotheses, and data analytic plan

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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