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Fetal Alcohol Syndrome/ARND Research Consortion

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ClinicalTrials.gov Identifier: NCT00164554
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 28, 2008
University of Oklahoma
Information provided by:
Centers for Disease Control and Prevention

Brief Summary:
Children will receive comprehensive evaluations through the UOHSC ABC program The assessment for the child will include: medical issues (including medication), dysmorphic examination, intellectual assessment, academic achievement, language, and motor skills. This program will provide appropriate non-study services and referrals. Eligible families will be randomly assigned to treatment group or control group. Treatment group will receive Parent Child Interaction Therapy (PCIT). The Control group will receive standard referrals and services through the ABC program and the parent education/advocacy component of the project.

Condition or disease Intervention/treatment Phase
Fetal Alcohol Syndrome Behavioral: Parent-child Interaction Therapy (PCIT) Phase 1 Phase 2

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Fetal Alcohol Syndrome/ARND Research Consortion-Oklahoma
Study Start Date : October 2001
Estimated Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. compliance with directives

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Children ages 3 to 7 years

Information from the National Library of Medicine

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): NCT00164554

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73190
Sponsors and Collaborators
Centers for Disease Control and Prevention
University of Oklahoma
Principal Investigator: John Mulvihill, MD University of Oklahoma

ClinicalTrials.gov Identifier: NCT00164554     History of Changes
Other Study ID Numbers: CDC-NCBDDD-3813
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: April 28, 2008
Last Verified: September 2005

Keywords provided by Centers for Disease Control and Prevention:

Additional relevant MeSH terms:
Fetal Alcohol Spectrum Disorders
Pathologic Processes
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders