Fetal Alcohol Syndrome/ARND Research Consortion
|ClinicalTrials.gov Identifier: NCT00164554|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 28, 2008
|Condition or disease||Intervention/treatment||Phase|
|Fetal Alcohol Syndrome||Behavioral: Parent-child Interaction Therapy (PCIT)||Phase 1 Phase 2|
PCIT has been adapted by the applicant for group administration. The intervention will consist of 90-minute sessions of PCIT once a week for 14 weeks. During PCIT sessions parents and children will participate in activities that promote interactions. A behavior specialist who will be observing through a two-way mirror assists parents in development of appropriate behaviors and interaction techniques. Parents will be prompted by use of in-ear devices (i.e., bug in the ear). This intervention has been shown to be effective in other populations. For each family, individualized goals for parent-child interactions will be set and reviewed each session. Homework assignments also will be given.
Parent Component: Three 90-minute sessions conducted in a group format. Topics will include: FAS/ARND education, impact of FAS/ARND on families, specific development of a child with FAS/ARND, and FAS/ARND social skills and deficits.
Evaluation Plan: Treatment and control groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 6, 12, and 18-month follow-ups. Process (e.g., parent satisfaction, compliance, etc) and outcome (e.g., behavior, family functioning, etc) measures will be evaluated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Fetal Alcohol Syndrome/ARND Research Consortion-Oklahoma|
|Study Start Date :||October 2001|
|Estimated Study Completion Date :||June 2005|
- compliance with directives
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164554
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73190|
|Principal Investigator:||John Mulvihill, MD||University of Oklahoma|