Fetal Alcohol Syndrome/ARND Research Consortion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fetal Alcohol Syndrome

Keywords

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treatment control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

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Parent-child Interaction Therapy (PCIT)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children ages 3 to 7 years

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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John Mulvihill, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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U84/CCU020163-02

Identifier Type: -

Identifier Source: secondary_id

CDC-NCBDDD-3813