ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Fetal Alcohol Syndrome: Socio-Cognitive Habilitation

This study has been completed.

Sponsors and Collaborators: Centers for Disease Control and Prevention
Emory University
Kennedy-Krieger Research Institute
Marcus Institute
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00164229
  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 I
Phase II

MedlinePlus related topics:   Fetal Alcohol Syndrome   

Drug Information available for:   Ethanol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Study to Investigate the Effectiveness of a Math Intervention for Children With Fetal Alcohol Syndrome or Related Condition

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

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
Centers for Disease Control and Prevention
Emory University
Kennedy-Krieger Research Institute
Marcus Institute

Investigators
Principal Investigator:     claire coles, PhD     Marcus Institute    
  More Information


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

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

Study placed in the following topic categories:
Alcohol-Induced Disorders
Fetal Diseases
Fetal Alcohol Syndrome
Pregnancy Complications
Fetal alcohol syndrome
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on October 24, 2008




Links to all studies - primarily for crawlers