A Family Depression Prevention Program (FDP)

• ClinicalTrials.gov Identifier: NCT02021578
• Recruitment Status: Active, not recruiting
• First Posted: December 27, 2013
• Last Update Posted: February 8, 2022
• Sponsor: Vanderbilt University
• Collaborator: San Diego State University
• Information provided by (Responsible Party): Judith Garber, Vanderbilt University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression	Behavioral: Family Cognitive Behavioral Prevention; Behavioral: Written information	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Interviewers who assess diagnostic outcomes are masked to participant condition.
• Primary Purpose: Prevention
• Official Title: Family Cognitive Behavioral Prevention of Depression in Youth and Parents
• Actual Study Start Date: December 2014
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: May 2022

Arms and Interventions

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: Cognitive behavioral intervention; Coping skills training; Parent 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

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 9 Years to 15 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

United States, California

San Diego State University

San Diego, California, United States, 92120-4913

United States, Tennessee

Vanderbilt University

Nashville, Tennessee, United States, 37203-5721

Sponsors and Collaborators

Vanderbilt University

San Diego State University

Investigators

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

More Information

Publications:

Compas BE, Forehand R, Keller G, Champion JE, Rakow A, Reeslund KL, McKee L, Fear JM, Colletti CJ, Hardcastle E, Merchant MJ, Roberts L, Potts J, Garai E, Coffelt N, Roland E, Sterba SK, Cole DA. Randomized controlled trial of a family cognitive-behavioral preventive intervention for children of depressed parents. J Consult Clin Psychol. 2009 Dec;77(6):1007-20. doi: 10.1037/a0016930.

Compas BE, Champion JE, Forehand R, Cole DA, Reeslund KL, Fear J, Hardcastle EJ, Keller G, Rakow A, Garai E, Merchant MJ, Roberts L. Coping and parenting: Mediators of 12-month outcomes of a family group cognitive-behavioral preventive intervention with families of depressed parents. J Consult Clin Psychol. 2010 Oct;78(5):623-34. doi: 10.1037/a0020459.

Compas BE, Forehand R, Thigpen JC, Keller G, Hardcastle EJ, Cole DA, Potts J, Watson KH, Rakow A, Colletti C, Reeslund K, Fear J, Garai E, McKee L, Merchant MJ, Roberts L. Family group cognitive-behavioral preventive intervention for families of depressed parents: 18- and 24-month outcomes. J Consult Clin Psychol. 2011 Aug;79(4):488-99. doi: 10.1037/a0024254.

Garber J, Clarke GN, Weersing VR, Beardslee WR, Brent DA, Gladstone TR, DeBar LL, Lynch FL, D'Angelo E, Hollon SD, Shamseddeen W, Iyengar S. Prevention of depression in at-risk adolescents: a randomized controlled trial. JAMA. 2009 Jun 3;301(21):2215-24. doi: 10.1001/jama.2009.788.

Beardslee WR, Brent DA, Weersing VR, Clarke GN, Porta G, Hollon SD, Gladstone TR, Gallop R, Lynch FL, Iyengar S, DeBar L, Garber J. Prevention of depression in at-risk adolescents: longer-term effects. JAMA Psychiatry. 2013 Nov;70(11):1161-70. doi: 10.1001/jamapsychiatry.2013.295.

• Responsible Party: Judith Garber, Professor, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT02021578
• Other Study ID Numbers: 8482529
• First Posted: December 27, 2013
• Last Update Posted: February 8, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual participant data reported in publications will be made available to researchers upon request.
• Supporting Materials: Study Protocol; Informed Consent Form (ICF); Analytic Code
• Time Frame: Data will be available after publication of results.
• Access Criteria: Written requests for specific data, hypotheses, and data analytic plan

Keywords provided by Judith Garber, Vanderbilt University:

Depression; Mood disorder

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders