NCT00183365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 depression

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 9, 2026

Status Verified

February 1, 2014

Enrollment Period

2.8 years

First QC Date

September 12, 2005

Last Update Submit

January 8, 2026

Conditions

Keywords

FamilyParentingDepressionGroup Intervention

Outcome Measures

Primary Outcomes (1)

  • Child psychiatric symptomology

    Measured immediately post-treatment and at 6-month follow-up

Secondary Outcomes (1)

  • Parenting skills, family functioning, and parent social support

    Measured immediately post-treatment and at 6-month follow-up

Study Arms (2)

1

EXPERIMENTAL

Participants will receive the Protecting Families Program with individual parent training

Behavioral: Parent Skills TrainingBehavioral: Protecting Families Program (PFP)

2

ACTIVE COMPARATOR

Participants will receive parent training alone

Behavioral: Parent Skills Training

Interventions

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

12

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.

1

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Guy Diamond, PhD

    University of Pennsylvania / CHOP

    PRINCIPAL INVESTIGATOR
  • Rhonda Boyd, PhD

    University of Pennsylvania / CHOP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

October 1, 2005

Primary Completion

July 1, 2008

Study Completion

November 1, 2009

Last Updated

January 9, 2026

Record last verified: 2014-02

Locations