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Clinical Trials/NCT00183482
NCT00183482CompletedNot Applicable

Family Cognitive Behavioral Prevention of Depression in Children of Parents With a History of Major Depressive Disorder

Vanderbilt University2 sites in 1 country304 target enrollmentStarted: August 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
304
Locations
2
Primary Endpoint
Internalizing and Externalizing symptoms in children

Study Overview

Brief Summary

This study will determine the effectiveness of cognitive behavioral therapy (CBT) versus educational treatment in preventing depression in the children of parents with a history of depression.

Detailed Description

Depression is a serious condition that can affect a person's work, relationships, and quality of life. Studies have shown that children of depressed parents are at a higher risk for developing depression than those whose parents have not experienced depression. Safe and effective treatments that can help prevent children of depressed parents from becoming depressed are needed. This study will compare CBT to depression education to determine which is more effective in preventing depression in the children of depressed parents.

Families will be randomly assigned to receive weekly sessions of either CBT or depression education for 12 weeks. Parents in the CBT group will be taught skills to more effectively raise their children and to better manage their depressive symptoms; their children will be taught skills to cope with the stress of their parents' depression. Families in the education group will be informed about the ways that depression can affect individuals with depression and their families.

Study visits will occur at study entry and at Week 12. Several follow-up visits will occur for up to 2 years after the interventional part of the study. At each visit, a clinician will make direct observations of the depressed parent's interaction with his or her children. In addition, families will be interviewed and will complete questionnaires about the parent's depressive symptoms and family interaction.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

Investigators and outcome assessors are masked to condition of participants.

Eligibility Criteria

Ages
9 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Internalizing and Externalizing symptoms in children

Time Frame: 12 months

Child Behavior Checklist; Youth Self-Report; Internalizing and Externalizing Problems; Minimum T score = 40; Maximum T score = 80; Higher scores reflect worse outcome

Secondary Outcomes

  • Depressive symptoms in parents(12 months)
  • Parenting skills of parents(12 months)
  • Onset of depressive disorders in children(12 months)
  • Coping skills of children(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bruce Compas

Patricia and Rodes Hart Professor

Vanderbilt University

Study Sites (2)

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