Effect of Family-Based Prevention on Children of Depressed Parents
Children of Depressed Parents: Family-Based Prevention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Children of depressed parents are at risk for developing social-emotional problems. Despite the fact that economic hardship is a strong risk factor for both maternal depression and poor child development, little research has been conducted to develop prevention programs for low-income urban families. This randomized, open-label study will address the research gap by developing and pilot-testing the Protecting Families Program (PFP), a family-based, multi-component prevention program. The PFP will offer its services to low-income, urban, depressed parents and their children between the ages of 9 and 14.
Prior to the interventional portion of the study, several small focus groups composed of mental-health care providers and depressed parents will meet. The purpose of these focus groups will be to gather information that will help maximize the effectiveness of the remainder of the study. The interventional phase will compare PFP combined with individual parent training versus parent training alone. Participants will be randomly assigned to one of these two intervention groups. The study will last a total of 10 weeks. Both groups will meet once each week. PFP will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (CBT) group for the focal child. Participants' symptoms, diagnosis, functional status, family functioning, cognitive factors, and parenting practices will be assessed at the study start date, immediately post-intervention, and 6 months post-intervention.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Center for Family Intervention Science; The Children's Hospital of Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parent is currently in treatment
- Parent's primary DSM-IV diagnosis is major depressive disorder, dysthymia, or depression not otherwise specified
- Parent's child lives with him/her at least part time
Exclusion criteria:
- Parent has a history or current diagnosis of any psychotic disorder or organic brain syndrome
- Parent has history of bipolar or schizoaffective disorder
- Parent's IQ is below 70
- Parent has any serious medical or neurological disorder or condition that may prevent weekly participation
- Parent has chronic pain that may prevent weekly participation
- Parent or child is currently suicidal to the extent that it will interfere with outpatient treatment
- Parent has a current substance dependence
- Child is currently seeking psychological treatment
- Child is mentally retarded (determined by school and clinic records)
- Child has a clinically severe psychiatric diagnosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Participants will receive the Protecting Families Program with individual parent training
|
Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.
Participants will receive 10 weeks of PFP, which will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (CBT) group for the focal child.
|
|
Active Comparator: 2
Participants will receive parent training alone
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Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Child psychiatric symptomology
Time Frame: Measured immediately post-treatment and at 6-month follow-up
|
Measured immediately post-treatment and at 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Parenting skills, family functioning, and parent social support
Time Frame: Measured immediately post-treatment and at 6-month follow-up
|
Measured immediately post-treatment and at 6-month follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Guy Diamond, PhD, University of Pennsylvania / CHOP
- Principal Investigator: Rhonda Boyd, PhD, University of Pennsylvania / CHOP
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-8-3934
- DDTR B4-ARD
- R34MH071868 (U.S. NIH Grant/Contract)
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