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Fetal Alcohol Syndrome/ARND Research Consortion

Fetal Alcohol Syndrome/ARND Research Consortion-Oklahoma

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00164554
Enrollment
100
Registered
2005-09-14
Start date
2001-10-31
Completion date
2005-06-30
Last updated
2008-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Alcohol Syndrome

Keywords

treatment, control

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.

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.

Interventions

Sponsors

University of Oklahoma
CollaboratorOTHER
Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
Yes

Inclusion criteria

* Children ages 3 to 7 years

Design outcomes

Primary

MeasureTime frame
compliance with directives

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026