Effect of Family-Based Prevention on Children of Depressed Parents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00183365
First received: September 12, 2005
Last updated: February 6, 2014
Last verified: February 2014

September 12, 2005
February 6, 2014
October 2005
July 2008   (final data collection date for primary outcome measure)
Child psychiatric symptomology [ Time Frame: Measured immediately post-treatment and at 6-month follow-up ] [ Designated as safety issue: No ]
Child psychiatric symptomology immediately post-intervention and 6 months post-intervention
Complete list of historical versions of study NCT00183365 on ClinicalTrials.gov Archive Site
Parenting skills, family functioning, and parent social support [ Time Frame: Measured immediately post-treatment and at 6-month follow-up ] [ Designated as safety issue: No ]
Parenting skills, family functioning, and parent social support immediately post-intervention and 6 months post-intervention
Not Provided
Not Provided
 
Effect of Family-Based Prevention on Children of Depressed Parents
Children of Depressed Parents: Family-Based Prevention

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Depression
  • 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.
  • Experimental: 1
    Participants will receive the Protecting Families Program with individual parent training
    Interventions:
    • Behavioral: Parent Skills Training
    • Behavioral: Protecting Families Program (PFP)
  • Active Comparator: 2
    Participants will receive parent training alone
    Intervention: Behavioral: Parent Skills Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
November 2009
July 2008   (final data collection date for primary outcome measure)

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
Both
9 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183365
2004-8-3934, R34MH071868, DDTR B4-ARD
Not Provided
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
National Institute of Mental Health (NIMH)
Principal Investigator: Guy Diamond, PhD University of Pennsylvania / CHOP
Principal Investigator: Rhonda Boyd, PhD University of Pennsylvania / CHOP
Children's Hospital of Philadelphia
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP