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
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Parent Skills Training Behavioral: Protecting Families Program (PFP)||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Children of Depressed Parents: Family-Based Prevention|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||November 2009|
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.
- Child psychiatric symptomology [ Time Frame: Measured immediately post-treatment and at 6-month follow-up ]
- Parenting skills, family functioning, and parent social support [ Time Frame: Measured immediately post-treatment and at 6-month follow-up ]
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
|United States, Pennsylvania|
|Center for Family Intervention Science; The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Guy Diamond, PhD||University of Pennsylvania / CHOP|
|Principal Investigator:||Rhonda Boyd, PhD||University of Pennsylvania / CHOP|