Family Cognitive Behavioral Therapy for Preventing Depression in Children

NCT ID: NCT00183482

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Repeated measures ANCOVA design.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigators and outcome assessors are masked to condition of participants.

Study Groups

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Family Group Cognitive Behavioral

The intervention is a family group cognitive behavioral program for families of parents with a history of depression to teach parenting skills to parents and coping skills to children.

Group Type EXPERIMENTAL

Family Group Cognitive Behavioral

Intervention Type BEHAVIORAL

Groups of families receive training in parenting and children learn about coping in ten weekly sessions and then three monthly sessions

Written Information

The comparison arm involves providing written information about depression and stress to parents with a history of depression and their children.

Group Type ACTIVE_COMPARATOR

Written Information

Intervention Type BEHAVIORAL

Families are mailed written materials that describe depression and stress in families with a depressed parent.

Interventions

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Family Group Cognitive Behavioral

Groups of families receive training in parenting and children learn about coping in ten weekly sessions and then three monthly sessions

Intervention Type BEHAVIORAL

Written Information

Families are mailed written materials that describe depression and stress in families with a depressed parent.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Families with at least one parent with a history of depression during the life of his or her child
* Families with at least one child between the age of 10 and 15
* Parent or guardian willing to provide informed consent for participating children

Exclusion Criteria

* Parent with bipolar disorder or schizophrenia
* Child with conduct disorder or pervasive developmental disorder
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Bruce Compas

Patricia and Rodes Hart Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce E. Compas, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Ciriegio AE, Pine AE, Cole DA, McKee LG, Forehand R, Compas BE. Mediators of a randomized controlled trial of a preventive intervention for youth of parents with depressive disorders. J Consult Clin Psychol. 2025 Jan;93(1):1-13. doi: 10.1037/ccp0000928.

Reference Type DERIVED
PMID: 39786802 (View on PubMed)

Other Identifiers

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R01MH100258

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH100258

Identifier Type: NIH

Identifier Source: org_study_id

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