Fetal Alcohol Syndrome: Socio-Cognitive Habilitation

This study has been completed.
Sponsor:
Collaborators:
Emory University
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Marcus Institute
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164229
First received: September 9, 2005
Last updated: April 25, 2008
Last verified: September 2005
  Purpose

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 Intervention Phase
Fetal Alcohol Syndrome
Behavioral: math
Behavioral: behavior regulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Study to Investigate the Effectiveness of a Math Intervention for Children With Fetal Alcohol Syndrome or Related Condition

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • math knowledge
  • math skills

Secondary Outcome Measures:
  • behavior regulation
  • parent knowledge of FAS

Estimated Enrollment: 100
Study Start Date: October 2001
Estimated Study Completion Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   42 Months to 81 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age 6 years 9 months or older
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164229

Locations
United States, Georgia
Marcus Institute
Atlanta, Georgia, United States, 30333
Sponsors and Collaborators
Emory University
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Marcus Institute
Investigators
Principal Investigator: claire coles, PhD Marcus Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00164229     History of Changes
Other Study ID Numbers: CDC-NCBDDD-3721, U84ccu320162
Study First Received: September 9, 2005
Last Updated: April 25, 2008
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
treatment
control

Additional relevant MeSH terms:
Fetal Alcohol Spectrum Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 26, 2014