We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Family-Based Prevention on Children of Depressed Parents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00183365
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 7, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Parent Skills Training Behavioral: Protecting Families Program (PFP) Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Children of Depressed Parents: Family-Based Prevention
Study Start Date : October 2005
Primary Completion Date : July 2008
Study Completion Date : November 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Participants will receive the Protecting Families Program with individual parent training
Behavioral: Parent Skills Training
Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.
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.
Active Comparator: 2
Participants will receive parent training alone
Behavioral: Parent Skills Training
Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.


Outcome Measures

Primary Outcome Measures :
  1. Child psychiatric symptomology [ Time Frame: Measured immediately post-treatment and at 6-month follow-up ]

Secondary Outcome Measures :
  1. Parenting skills, family functioning, and parent social support [ Time Frame: Measured immediately post-treatment and at 6-month follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183365


Locations
United States, Pennsylvania
Center for Family Intervention Science; The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Guy Diamond, PhD University of Pennsylvania / CHOP
Principal Investigator: Rhonda Boyd, PhD University of Pennsylvania / CHOP
More Information

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00183365     History of Changes
Other Study ID Numbers: 2004-8-3934
R34MH071868 ( U.S. NIH Grant/Contract )
DDTR B4-ARD
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014

Keywords provided by Children's Hospital of Philadelphia:
Family
Parenting
Depression
Group Intervention

Additional relevant MeSH terms:
Depression
Behavioral Symptoms