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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
  Purpose
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.

Condition Intervention Phase
Depression
Behavioral: Family Cognitive Behavioral Therapy (CBT)
Behavioral: Depression Education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Family Cognitive Behavioral Prevention of Depression in Children of Parents With a History of Major Depressive Disorder

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 750
Study Start Date: August 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183482

Contacts
Contact: Bruce E. Compas, PhD 615-322-8306 bruce.compas@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37203
Contact: Bruce E. Compas, PhD    615-322-8306    bruce.compas@vanderbilt.edu   
Principal Investigator: Bruce E. Compas, PhD         
Sponsors and Collaborators
Vanderbilt University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Bruce E. Compas, PhD Vanderbilt University
  More Information

Responsible Party: Bruce Compas, Patricia and Rodes Hart Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00183482     History of Changes
Other Study ID Numbers: R01MH069940  DDTR B4-ARD 
Study First Received: September 13, 2005
Last Updated: November 17, 2015
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
Parents
Child
Stress
CBT

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 08, 2016