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Clinical Trials/NCT02021578
NCT02021578
Completed
Not Applicable

Family Cognitive Behavioral Prevention of Depression in Youth and Parents

Vanderbilt University2 sites in 1 country304 target enrollmentAugust 1, 2014
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Vanderbilt University
Enrollment
304
Locations
2
Primary Endpoint
In children, the primary outcome is level of symptoms on the Youth Self-report form.
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2014
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Judith Garber

Professor

Vanderbilt University

Eligibility 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)

Outcomes

Primary Outcomes

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 Outcomes

  • In children, level of internalizing and externalizing symptoms on the Child Behavior Checklist completed by parent about the child(12 months)
  • Parents: Patient Health Questionnaire - 9 (PHQ-9)(12 months)
  • Children: depressive diagnoses(12 months)

Study Sites (2)

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