Skip to main content
OpenTrials
Completed

NCT Number: NCT00183365

Effect of Family-Based Prevention on Children of Depressed Parents

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parent skills training

Behavioral

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

Protecting Families Program (PFP)

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.

Primary outcomes

  1. Child psychiatric symptomology

    Time frame: Measured immediately post-treatment and at 6-month follow-up

Secondary outcomes

  1. Parenting skills, family functioning, and parent social support

    Time frame: Measured immediately post-treatment and at 6-month follow-up

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Children of Depressed Parents: Family-Based Prevention

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.