Family Cognitive Behavioral Therapy for Preventing Depression in Children

Depression Clinical Trial

Official title:

Family Cognitive Behavioral Prevention of Depression in Children of Parents With a History of Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183482
• Other study ID #: R01MH100258
• Secondary ID: R01MH100258
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Family Group Cognitive Behavioral
Groups of families receive training in parenting and children learn about coping in ten weekly sessions and then three monthly sessions
• Written Information
Families are mailed written materials that describe depression and stress in families with a depressed parent.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	Depressive symptoms in parents	Patient Health Questionnaire - 9; Total Depression Symptoms; Minimum score = 0; Maximum score = 27; Higher scores reflect worse outcomes	12 months
Secondary	Coping skills of children	Responses to Stress Questionnaire; Secondary control coping scale; Minimum score = 4; Maximum score = 16; Higher scores reflect better outcomes	12 months
Secondary	Parenting skills of parents	Parent-child interaction coded	12 months
Secondary	Onset of depressive disorders in children	Interviews	12 months