- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00183482
Family Cognitive Behavioral Therapy for Preventing Depression in Children
Family Cognitive Behavioral Prevention of Depression in Children of Parents With a History of Major Depressive Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Vanderbilt University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria for Participating Families:
- 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 for All Participants:
- Parent with bipolar disorder or schizophrenia
- Child with conduct disorder or pervasive developmental disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Groups of families receive training in parenting and children learn about coping in ten weekly sessions and then three monthly sessions
|
|
Active Comparator: Written Information
The comparison arm involves providing written information about depression and stress to parents with a history of depression and their children.
|
Families are mailed written materials that describe depression and stress in families with a depressed parent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms in parents
Time Frame: 12 months
|
Patient Health Questionnaire - 9; Total Depression Symptoms; Minimum score = 0; Maximum score = 27; Higher scores reflect worse outcomes
|
12 months
|
|
Coping skills of children
Time Frame: 12 months
|
Responses to Stress Questionnaire; Secondary control coping scale; Minimum score = 4; Maximum score = 16; Higher scores reflect better outcomes
|
12 months
|
|
Parenting skills of parents
Time Frame: 12 months
|
Parent-child interaction coded
|
12 months
|
|
Onset of depressive disorders in children
Time Frame: 12 months
|
Interviews
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bruce E. Compas, PhD, Vanderbilt University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH100258 (U.S. NIH Grant/Contract)
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