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A Family Depression Prevention Program (FDP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021578
Recruitment Status : Active, not recruiting
First Posted : December 27, 2013
Last Update Posted : February 8, 2022
Sponsor:
Collaborator:
San Diego State University
Information provided by (Responsible Party):
Judith Garber, 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.


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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

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




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.



Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021578


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

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Responsible Party: Judith Garber, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02021578    
Other Study ID Numbers: 8482529
First Posted: December 27, 2013    Key Record Dates
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:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders