Family Cognitive Behavioral Therapy for Preventing Depression in Children

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Family Group Cognitive Behavioral; Behavioral: Written Information

• Registration Number: NCT00183482
• Lead Sponsor: Vanderbilt University

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 Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Study Start: 2014-08-01
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-14
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family Group Cognitive Behavioral	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.
Written Information	Written Information	The comparison arm involves providing written information about depression and stress to parents with a history of depression and their children.

Primary Outcome Measures

Name	Time	Method
Internalizing and Externalizing symptoms in children	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 Outcome Measures

Name	Time	Method
Depressive symptoms in parents	12 months	Patient Health Questionnaire - 9; Total Depression Symptoms; Minimum score = 0; Maximum score = 27; Higher scores reflect worse outcomes
Parenting skills of parents	12 months	Parent-child interaction coded
Onset of depressive disorders in children	12 months	Interviews
Coping skills of children	12 months	Responses to Stress Questionnaire; Secondary control coping scale; Minimum score = 4; Maximum score = 16; Higher scores reflect better outcomes

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States