Family Cognitive Behavioral Therapy for Preventing Depression in Children
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|ClinicalTrials.gov Identifier: NCT00183482|
Recruitment Status : Recruiting
First Posted : September 16, 2005
Last Update Posted : September 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Family Group Cognitive Behavioral Behavioral: Written Information||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Repeated measures ANOCA design.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Investigators and outcome assessors are masked to condition of particpants.|
|Official Title:||Family Cognitive Behavioral Prevention of Depression in Children of Parents With a History of Major Depressive Disorder|
|Actual Study Start Date :||August 1, 2014|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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.
Behavioral: 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
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.
Behavioral: Written Information
Families are mailed written materials that describe depression and stress in families with a depressed parent.
- Depressive episodes [ Time Frame: 2 years ]Interview about depressive symptoms over two years
- Parenting skills of parents; measured at baseline and month 6 [ Time Frame: 2 years ]Parent-child interaction coded
- Coping skills of children; measured at baseline and month 6 [ Time Frame: 2 years ]Responses to Stress Questionnaire
- Depression in parents; measured at baseline and month 6 [ Time Frame: 2 years ]Patient Health Questionnaire - 9
- Internalizing and externalizing symptoms in children [ Time Frame: 6 months ]Child Behavior Checklist; Youth Self-Report
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183482
|Contact: Bruce E. Compas, PhDemail@example.com|
|Contact: Judy Garber, PhDfirstname.lastname@example.org|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Contact: Bruce E. Compas, PhD 615-322-8306 email@example.com|
|Principal Investigator: Bruce E. Compas, PhD|
|Principal Investigator:||Bruce E. Compas, PhD||Vanderbilt University|