Fetal Alcohol Syndrome/ARND Research Consortion

Fetal Alcohol Syndrome/ARND Research Consortion-Oklahoma

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.

Study Overview

• Status: Completed
• Conditions: Fetal Alcohol Syndrome
• Intervention / Treatment: Behavioral: Parent-child Interaction Therapy (PCIT)

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
• Enrollment: 100
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73190
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children ages 3 to 7 years

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
compliance with directives

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Collaborators: University of Oklahoma
• Investigators: Principal Investigator: John Mulvihill, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Study Completion: June 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): April 28, 2008
• Last Update Submitted That Met QC Criteria: April 25, 2008
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Keywords: treatment; control
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Disease; Fetal Diseases; Pregnancy Complications; Alcohol-Induced Disorders; Syndrome; Fetal Alcohol Spectrum Disorders
• Other Study ID Numbers: CDC-NCBDDD-3813; U84/CCU020163-02