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Family Cognitive Behavioral Therapy for Preventing Depression in Children

Primary Purpose

Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Group Cognitive Behavioral
Written Information
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Parents, Child, Stress, CBT

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family Group Cognitive Behavioral

Written Information

Arm Description

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.

The comparison arm involves providing written information about depression and stress to parents with a history of depression and their children.

Outcomes

Primary Outcome Measures

Internalizing and Externalizing symptoms in children
Child Behavior Checklist; Youth Self-Report; Internalizing and Externalizing Problems; Minimum T score = 40; Maximum T score = 80; Higher scores reflect worse outcome

Secondary Outcome Measures

Depressive symptoms in parents
Patient Health Questionnaire - 9; Total Depression Symptoms; Minimum score = 0; Maximum score = 27; Higher scores reflect worse outcomes
Coping skills of children
Responses to Stress Questionnaire; Secondary control coping scale; Minimum score = 4; Maximum score = 16; Higher scores reflect better outcomes
Parenting skills of parents
Parent-child interaction coded
Onset of depressive disorders in children
Interviews

Full Information

First Posted
September 13, 2005
Last Updated
January 7, 2023
Sponsor
Vanderbilt University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00183482
Brief Title
Family Cognitive Behavioral Therapy for Preventing Depression in Children
Official Title
Family Cognitive Behavioral Prevention of Depression in Children of Parents With a History of Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Parents, Child, Stress, CBT

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Repeated measures ANCOVA design.
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigators and outcome assessors are masked to condition of participants.
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Family Group Cognitive Behavioral
Arm Type
Experimental
Arm Description
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.
Arm Title
Written Information
Arm Type
Active Comparator
Arm Description
The comparison arm involves providing written information about depression and stress to parents with a history of depression and their children.
Intervention Type
Behavioral
Intervention Name(s)
Family Group Cognitive Behavioral
Intervention Description
Groups of families receive training in parenting and children learn about coping in ten weekly sessions and then three monthly sessions
Intervention Type
Behavioral
Intervention Name(s)
Written Information
Intervention Description
Families are mailed written materials that describe depression and stress in families with a depressed parent.
Primary Outcome Measure Information:
Title
Internalizing and Externalizing symptoms in children
Description
Child Behavior Checklist; Youth Self-Report; Internalizing and Externalizing Problems; Minimum T score = 40; Maximum T score = 80; Higher scores reflect worse outcome
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Depressive symptoms in parents
Description
Patient Health Questionnaire - 9; Total Depression Symptoms; Minimum score = 0; Maximum score = 27; Higher scores reflect worse outcomes
Time Frame
12 months
Title
Coping skills of children
Description
Responses to Stress Questionnaire; Secondary control coping scale; Minimum score = 4; Maximum score = 16; Higher scores reflect better outcomes
Time Frame
12 months
Title
Parenting skills of parents
Description
Parent-child interaction coded
Time Frame
12 months
Title
Onset of depressive disorders in children
Description
Interviews
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce E. Compas, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

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Family Cognitive Behavioral Therapy for Preventing Depression in Children

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