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
-
-
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.
|
Parent training and cognitive behavioral intervention with parents.
Coping skills training with children.
Other Names:
|
|
Active Comparator: Written Information
Families receive written materials about depression and the effects of parental depression on children.
|
Reading materials about depression
Other Names:
|
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
Collaborators
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.
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
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