Fetal Alcohol Syndrome/ARND Research Consortion

Fetal Alcohol Syndrome Clinical Trial

Official title:

Fetal Alcohol Syndrome/ARND Research Consortion-Oklahoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164554
• Other study ID #: CDC-NCBDDD-3813
• Secondary ID: U84/CCU020163-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: April 25, 2008
• Start date: October 2001
• Est. completion date: June 2005

Study information

• Verified date: September 2005
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• Children ages 3 to 7 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• Syndrome

Intervention

Behavioral:
• Parent-child Interaction Therapy (PCIT)

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compliance with directives