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Fetal Alcohol Syndrome: Socio-Cognitive Habilitation

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: NCT00164229
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 28, 2008
Emory University
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Marcus Institute
Information provided by:
Centers for Disease Control and Prevention

Brief Summary:
Comprehensive evaluation (geneticist, psychologist, social worker, education specialist, others as indicated) to determine individual needs and treatment plan. Referrals for specific services (e.g., OT, counseling, medications, etc) will be to clinicians within the families' own communities. All families will receive evaluation, parent education/advocacy, and learning readiness program. Only the intervention group will receive the math intervention.

Condition or disease Intervention/treatment Phase
Fetal Alcohol Syndrome Behavioral: math Behavioral: behavior regulation Phase 1 Phase 2

Detailed Description:

Learning Readiness Program: This program will include: case management to secure needed services, medication consultation (psychiatrist), educational consultation/ liaison, Behavioral Regulation Training (BRT). BRT will include teaching parents about: 1) recognizing their child's arousal level (to avoid negative episodes), 2) recognizing their own arousal and how it contributes to a situation, 3) principles of social reinforcement (e.g., praise, ignore, etc), 4) "accidental teaching" (i.e., teaching when a situation/opportunity arises), 5) resource/support source identification, 6) to communicate choices rather than authoritative commands, and 6) reduction of repetitive prompts (nagging). The child will be taught: 1) the technique of Escape/No Escape for undesirable tasks, 2) arousal awareness, and 3) verbalization of situations and actions (e.g., I don't like it when mom yells at me for running in the house, so I won't run in the house).

Targeted Area of Intervention: MATH - 6 weeks of individualized math tutoring. Content of the tutoring will be tailored to age levels (either 3-6 yr olds or 6-9 yr olds). The High/Scope curriculum will be used (modified so that it can be individualized). In addition, visual materials and visual aids will be developed to address deficits in the visual-spatial skills of children with FAS/ARND. For teachers, a manual will be prepared to assist them in working with children who have FAS/ARND. The educational specialist will review the manual and techniques with each teacher involved with the child.

Parent component: Individual and small group sessions to include: FAS education, information on education system procedures, instruction for communicating with professionals, and support for advocating for their child. A caregiver manual will be prepared.

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-month follow-up. Process (e.g., parent satisfaction, compliance, etc) and outcome (e.g., math skill, behavior, family functioning, etc) measures will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Study to Investigate the Effectiveness of a Math Intervention for Children With Fetal Alcohol Syndrome or Related Condition
Study Start Date : October 2001
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. math knowledge
  2. math skills

Secondary Outcome Measures :
  1. behavior regulation
  2. parent knowledge of FAS

Information from the National Library of Medicine

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Ages Eligible for Study:   42 Months to 81 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • diagnosis of FAS or related condition
  • age 3 years six month or older

Exclusion Criteria:

  • age 6 years 9 months or older

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): NCT00164229

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United States, Georgia
Marcus Institute
Atlanta, Georgia, United States, 30333
Sponsors and Collaborators
Centers for Disease Control and Prevention
Emory University
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Marcus Institute
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Principal Investigator: claire coles, PhD Marcus Institute
Layout table for additonal information Identifier: NCT00164229    
Other Study ID Numbers: CDC-NCBDDD-3721
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: April 28, 2008
Last Verified: September 2005
Keywords provided by Centers for Disease Control and Prevention:
Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Pathologic Processes
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders