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Completed

NCT Number: NCT00164554

Fetal Alcohol Syndrome/ARND Research Consortion

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.

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Key information

Conditions

Fetal Alcohol Syndrome Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Alcohol Spectrum Disorders Fetal Diseases Pregnancy Complications Substance-Related Disorders Urogenital Diseases

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73190, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children ages 3 to 7 years

Treatment and study plan

Parent-Child Interaction Therapy (PCIT)

Behavioral

Primary outcomes

  1. compliance with directives

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • University of Oklahoma

Registry information

Official study title

Fetal Alcohol Syndrome/ARND Research Consortion-Oklahoma

Important dates

Study start
2001
Study completion
2005
First posted
Sep 14, 2005
Registry last updated
Apr 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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