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| 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. |
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| 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. |
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| 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) |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 42 | ||||||||
| Start Date † | October 2005 | ||||||||
| Completion Date | August 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion criteria:
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| Gender | Both | ||||||||
| Ages | 9 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| 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) | ||||||||
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| Investigators † |
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| 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 | ||||||||
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