ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Effect of Family-Based Prevention on Children of Depressed Parents

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Effect of Family-Based Prevention on Children of Depressed Parents
Official Title  Children of Depressed Parents: Family-Based Prevention
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.

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 Phase Phase I
Study Type  Interventional
Study Design  Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Child psychiatric symptomology [ Time Frame: Measured immediately post-treatment and at 6-month follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ]
Condition  Depression
Intervention  Behavioral: Parent Skills Training
Behavioral: Protecting Families Program (PFP)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  42
Start Date  October 2005
Completion Date August 2008
Eligibility 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
Gender Both
Ages 9 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Torrey A. Creed, PhD     267-426-5104     creed@email.chop.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00183365
Organization ID R34 MH71868
Secondary IDs †† DDTR B4-ARD
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Guy Diamond, PhD     University of Pennsylvania / CHOP    
Principal Investigator:     Rhonda Boyd, PhD     University of Pennsylvania / CHOP    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date  September 12, 2005
Last Updated Date February 27, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers