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Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00164307
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : November 8, 2005
University of California, Los Angeles
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Treatment Control Behavioral: Parent assisted social skills training Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Educational/Counseling/Training
Official Title: Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships
Study Start Date : October 2001
Study Completion Date : January 2005

Primary Outcome Measures :
  1. social skills
  2. peer relationships/friendships

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • non english speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00164307

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United States, California
University of California
Los Angeles, California, United States, 90024
Sponsors and Collaborators
Centers for Disease Control and Prevention
University of California, Los Angeles
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Principal Investigator: Mary O'Connor, PhD University of Califorrnia at Los Angeles
Layout table for additonal information Identifier: NCT00164307    
Other Study ID Numbers: CDC-NCBDDD-3642
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 8, 2005
Last Verified: September 2005