Effect of Family-Based Prevention on Children of Depressed Parents

NCT ID: NCT00183365

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2009-11-30

Brief Summary

This study will test the Protecting Families Program, a 10-week prevention program for depressed parents and their pre-teenage children, by comparing the effectiveness of the program versus parent training alone.

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Participants will receive the Protecting Families Program with individual parent training

Group Type: EXPERIMENTAL

Parent Skills Training

Intervention Type: BEHAVIORAL

Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.

Protecting Families Program (PFP)

Intervention Type: BEHAVIORAL

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.

2

Participants will receive parent training alone

Group Type: ACTIVE_COMPARATOR

Parent Skills Training

Intervention Type: BEHAVIORAL

Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.

Interventions

Parent Skills Training

Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.

Intervention Type: BEHAVIORAL

Protecting Families Program (PFP)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guy Diamond, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania / CHOP

Rhonda Boyd, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania / CHOP

Locations

Center for Family Intervention Science; The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R34MH071868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DDTR B4-ARD

Identifier Type: -

Identifier Source: secondary_id

2004-8-3934

Identifier Type: -

Identifier Source: org_study_id