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CompletedNCT00183365Updated Jan 9, 2026

Effect of Family-Based Prevention on Children of Depressed Parents

A Phase 1 interventional study of Parent Skills Training and Protecting Families Program (PFP) in Depression, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Children's Hospital of Philadelphia · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
9 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression

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Keywords

  • Family
  • Parenting
  • Depression
  • Group Intervention
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 42 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    1

    Participants will receive the Protecting Families Program with individual parent training

    Behavioral: Parent Skills Training · Behavioral: Protecting Families Program (PFP)

  • Active comparator
    2

    Participants will receive parent training alone

    Behavioral: Parent Skills Training

Interventions

  • BehavioralParent Skills Training

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

  • BehavioralProtecting 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.

06

What researchers measure

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

07

Study locations

1 site
  • Center for Family Intervention Science; The Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00183365
Lead sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Oct 2005
Primary completion
Jul 2008
Completion
Nov 2009
Last update
Jan 9, 2026

Study contacts

Guy Diamond, PhD
principal investigator · University of Pennsylvania / CHOP
Rhonda Boyd, PhD
principal investigator · University of Pennsylvania / CHOP
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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