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A Family Depression Prevention Program (FDP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Vanderbilt University
Sponsor:
Collaborator:
San Diego State University
Information provided by (Responsible Party):
Judy Garber, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT02021578
First received: December 19, 2013
Last updated: December 7, 2015
Last verified: December 2015
  Purpose

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 fewer onsets of depressive episodes and lower levels of anxious/depressive symptoms 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 Intervention
Depression
Behavioral: Family Cognitive Behavioral Prevention
Behavioral: Written information

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Family Cognitive Behavioral Prevention of Depression in Youth and Parents

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • In children, the primary outcome is onset of a depressive episode. In parents, the primary outcome is time in a depressive episode. [ Time Frame: up to two years ] [ Designated as safety issue: No ]

    For child participants, we will assess time to onset of a depressive disorder (e.g., Major Depressive Episode; persistent depressive disorder) using a semi-structured clinical interview, the Longitudinal Interval Follow-up Evaluation (LIFE).

    For parent participants, we also will use the LIFE to measure the amount of time in a depressive episode during the assessment interval.



Secondary Outcome Measures:
  • Parents: Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: past two weeks ] [ Designated as safety issue: No ]
    Parent participants: The PHQ-9 measures 9 symptoms of depression on a 4-point scale. Scores can range from 0 to 36.

  • Children: Youth Self-report (YSR) anxiety/depression subscale [ Time Frame: six months ] [ Designated as safety issue: No ]
    Children will complete the YSR, which is a self-report checklist containing 112 items scored on a 3-point scale.


Estimated Enrollment: 300
Study Start Date: December 2014
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 (12 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-, 18-, and 24-months from baseline.
  Eligibility

Ages Eligible for Study:   9 Years to 15 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parent with a current or history of a depressive disorder within child's life
  • Children ages 9.0 to 15.6 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021578

Locations
United States, California
San Diego State University Recruiting
San Diego, California, United States, 92120-4913
Contact: Robin Weersing, PhD    619-594-8892    robin.weersing@mail.sdsu.edu   
Principal Investigator: Robin Weersing, PhD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37203-5721
Contact: Judy Garber, PhD    615-343-0595    jgarber.vanderbilt@gmail.com   
Contact: Bruce Compas, PhD    615-322-8306    Bruce.Compas@Vanderbilt.edu   
Principal Investigator: Judy Garber, PhD         
Principal Investigator: Bruce Compas, PhD         
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:

Responsible Party: Judy Garber, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02021578     History of Changes
Other Study ID Numbers: 8482529 
Study First Received: December 19, 2013
Last Updated: December 7, 2015
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
Depression
Mood disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016