Family Cognitive Behavioral Therapy for Preventing Depression in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00183482
First received: September 13, 2005
Last updated: October 23, 2007
Last verified: June 2006
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Depression, anxiety, and disruptive behavior problems in children; measured at baseline and Week 12
  • Depression in parents; measured at baseline and Week 12

Secondary Outcome Measures:
  • Parenting skills of parents; measured at baseline and Week 12
  • Coping skills of children; measured at baseline and Week 12
  • Quality of parent-child relationship; measured at baseline and Week 12

Estimated Enrollment: 750
Study Start Date: July 2004
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
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
Investigators
Principal Investigator: Bruce E. Compas, PhD Vanderbilt University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00183482     History of Changes
Other Study ID Numbers: R01 MH69940, DDTR B4-ARD
Study First Received: September 13, 2005
Last Updated: October 23, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Parents
Child
Stress
CBT

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

ClinicalTrials.gov processed this record on October 23, 2014