A Clinic-based Prevention Program for Families of Depressed Mothers

Phase 1

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity; Conduct Disorder; Depression
• Interventions: Behavioral: Family Functioning Intervention

• Registration Number: NCT00149812
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

This study will assess the effectiveness of the "Keeping Families Strong" program (KFS) in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers.

Detailed Description

Children of depressed mothers are at high risk for developing serious psychiatric disorders. While genetics can account for about 34% of cases of childhood psychiatric disorders, children of depressed parents are at an even greater risk of developing mental disorders. The "Keeping Families Strong" program, or KFS, was built from evidence-based prevention programs. Its goal is to provide educational, cognitive, and behavioral interventions. These interventions are meant to enhance understanding about depression and its effects on families, improve communication within families, enhance social support, increase positive and consistent parenting, and improve child coping. This will likely improve the children's mental health, as well as positively affect the short- and long-term outcomes of parents recovering from a depressive episode. This study will evaluate the effectiveness of the KFS program in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers.

This 10-week, open-label program will involve 12 meetings, lasting 2 hours each. The parents and the children will attend separate meetings each week on the same nights. Children are prone to take on their parents' responsibilities to prevent them from becoming depressed. In order to avoid this, the children's meetings will focus on clarifying role responsibilities. There will be two additional follow-up meetings in the 3 months following completion of the program. All caregivers are encouraged to participate, including depressed fathers.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2008-06
• Study Completion: 2008-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Parent in treatment for depression
• Parent in maintenance phase of treatment

Exclusion Criteria

• Active substance abuse
• Substantial cognitive impairment
• Psychosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Family Functioning Intervention	Intervention: "Keeping Families Strong" Cognitive Behavioral and Communication intervention with mothers recovering from depression and their children, 9 years and older.

Primary Outcome Measures

Name	Time	Method
Acceptability of program to parents, children, clinicians, and administrators throughout 10 weeks	10 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in the understanding of depression, family communication, parenting practices, and child coping over a one-year period	1 year

Trial Locations

Locations (1)

Johns Hopkins Bloomberg School of Public Health; 🇺🇸 Baltimore, Maryland, United States