Family Cognitive Behavioral Therapy for Preventing Depression in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Vanderbilt University
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Bruce Compas, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00183482
First received: September 13, 2005
Last updated: November 17, 2015
Last verified: November 2015

September 13, 2005
November 17, 2015
August 2014
December 2017   (final data collection date for primary outcome measure)
  • Depression, anxiety, and disruptive behavior problems in children; measured at baseline and Week 12 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Depression in parents; measured at baseline and Week 12 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Depression, anxiety, and disruptive behavior problems in children; measured at Week 12 and up to 2 years after study end date
  • Depression in parents; measured at Week 12 and up to 2 years after study end date
Complete list of historical versions of study NCT00183482 on ClinicalTrials.gov Archive Site
  • Parenting skills of parents; measured at baseline and Week 12 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Coping skills of children; measured at baseline and Week 12 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of parent-child relationship; measured at baseline and Week 12 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Parenting skills of parents; measured at Week 12 and up to 2 years after study end date
  • Coping skills of children; measured at Week 12 and up to 2 years after study end date
  • Quality of parent-child relationship; measured at Week 12 and up to 2 years after study end date
Not Provided
Not Provided
 
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
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Depression
  • Behavioral: Family Cognitive Behavioral Therapy (CBT)
  • Behavioral: Depression Education
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Depression Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
February 2018
December 2017   (final data collection date for primary outcome measure)

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
Both
10 Years and older
No
Contact: Bruce E. Compas, PhD 615-322-8306 bruce.compas@vanderbilt.edu
United States
 
NCT00183482
R01MH069940, R01MH069940, DDTR B4-ARD
Yes
Not Provided
Not Provided
Bruce Compas, Vanderbilt University
Vanderbilt University
National Institute of Mental Health (NIMH)
Principal Investigator: Bruce E. Compas, PhD Vanderbilt University
Vanderbilt University
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP