Family Cognitive Behavioral Therapy for Preventing Depression in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00183482|
Recruitment Status : Recruiting
First Posted : September 16, 2005
Last Update Posted : April 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Family Cognitive Behavioral Therapy (CBT) Behavioral: Depression Education||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, 2010|
|Actual Primary Completion Date :||December 31, 2015|
|Estimated Study Completion Date :||December 31, 2017|
Experimental: Family Group Cognitive Behavioral
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 Cognitive Behavioral Therapy (CBT)|
Active Comparator: Written Information Control
Provision of information about depression to parents with a history of depression and their children.
|Behavioral: Depression Education|
- Depression, anxiety, and disruptive behavior problems in children; measured at baseline and Week 12 [ Time Frame: 2 years ]
- Depression in parents; measured at baseline and Week 12 [ Time Frame: 2 years ]
- Parenting skills of parents; measured at baseline and Week 12 [ Time Frame: 2 years ]
- Coping skills of children; measured at baseline and Week 12 [ Time Frame: 2 years ]
- Quality of parent-child relationship; measured at baseline and Week 12 [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183482
|Contact: Bruce E. Compas, 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|