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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00183365 |
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 |
Behavioral: Parent Skills Training Behavioral: Protecting Families Program (PFP) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Children of Depressed Parents: Family-Based Prevention |
Estimated Enrollment: | 42 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Participants will receive the Protecting Families Program with individual parent training
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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.
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2: Active Comparator
Participants will receive parent training alone
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Behavioral: Parent Skills Training
Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.
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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.
Ages Eligible for Study: | 9 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contact: Torrey A. Creed, PhD | 267-426-5104 | creed@email.chop.edu |
United States, Pennsylvania | |
Center for Family Intervention Science; The Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Torrey A. Creed, PhD 267-426-5104 creed@email.chop.edu |
Principal Investigator: | Guy Diamond, PhD | University of Pennsylvania / CHOP |
Principal Investigator: | Rhonda Boyd, PhD | University of Pennsylvania / CHOP |
Responsible Party: | Children's Hospital of Philadelphia ( Guy S. Diamond, PhD ) |
Study ID Numbers: | R34 MH71868, DDTR B4-ARD |
Study First Received: | September 12, 2005 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00183365 |
Health Authority: | United States: Federal Government |
Family Parenting Depression Group Intervention |
Depression Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |