Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships

Phase 1

Completed

• Conditions: Treatment; Control

• Registration Number: NCT00164307
• Lead Sponsor: Centers for Disease Control and Prevention

Brief Summary

Children will be randomly assigned to a Parent-assisted social skills training or Wait list. Baseline and post intervention rating will be obtained from teachers.

Detailed Description

Targeted Area of Intervention: Social skills and development of best friend relationships. The specific intervention will be twelve small group sessions (90 minutes each) over a 6-week period. Child sessions consist of 4 components: 1) children report on homework assignments; 2) didactic presentation, behavioral rehearsal, and coaching, 3) coached play, and 4) new homework activities assigned with parent. Topics to be addressed across sessions include: reduction of maladaptive behaviors, information exchange techniques, places and times to make friends, group acceptance, praising other children, negotiation, play dates, dealing with teasing, and winner/loser skills. At the start of the intervention, parent and children will work with staff to develop a list of social skills, behaviors, and goals that they would like targeted for each child.

Parent component: Kathleen Mitchell (NOFAS) is an investigator to provide parent input to the study. Parent-only sessions will instruct them on key features being taught to their child. Concurrent parent sessions will include: 1) education on FAS/ARND, 2) parents present specific issues with their child, 3) review of current child session objectives and techniques, 4) new homework activities developed, 5) parent and child together review homework.

Evaluation Plan: Treatment and control (WL) groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 4-month follow-up. Baseline parent measures include Social Skills Rating Scale, FAS Behavior Scale, and Test of Advocacy Knowledge. Baseline child measures include knowledge of social skills. Process (e.g., homework completion, attendance, etc) and outcome (e.g., social skills ratings, progress towards individual goals) measures will be evaluated.

Study Timeline

• Study Start: 2001-10
• Study Completion: 2005-01
• Status Verified: 2005-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Last Update Submitted: 2005-11-07
• Last Update Posted: 2005-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• children ages 6 to 8 years
• history of prenatal alcohol exposure

Exclusion Criteria

• non english speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
peer relationships/friendships
social skills

Trial Locations

Locations (1)

University of California; 🇺🇸 Los Angeles, California, United States