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	Intervention	Phase
Depression	Behavior: Penn Optimism Program (POP)  Behavior: Parent Skills Training  Behavior: Community Meal  Behavior: Emotional Coaching	Phase I

Further Study Details: 

Primary Outcomes: Child psychiatric symptomology immediately post-intervention and 6 months post-intervention
Secondary Outcomes: Parenting skills, family functioning, and parent social support immediately post-intervention and 6 months post-intervention
Expected Total Enrollment:  42

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 12.

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.

Ages Eligible for Study:  9 Years and above,  Genders Eligible for Study:  Both

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 (age 9-14) 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00183365

Natashia M. Robbins, M.S.      267-426-5104    robbinsn@email.chop.edu

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

Study chairs or principal investigators

Guy Diamond, Ph.D.,  Principal Investigator,  University of Pennsylvania / CHOP   
Rhonda Boyd, Ph.D.,  Principal Investigator,  University of Pennsylvania / CHOP   

Study ID Numbers:  MH71868-01
Last Updated:  September 15, 2005
Record first received:  September 12, 2005
ClinicalTrials.gov Identifier:  NCT00183365
Health Authority: United States: Institutional Review Board; United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-20