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

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date April 28, 2008
Study Start Date  ICMJE October 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • math knowledge
  • math skills
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • behavior regulation
  • parent knowledge of FAS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fetal Alcohol Syndrome: Socio-Cognitive Habilitation
Official Title  ICMJE Study to Investigate the Effectiveness of a Math Intervention for Children With Fetal Alcohol Syndrome or Related Condition
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Condition  ICMJE Fetal Alcohol Syndrome
Intervention  ICMJE
  • Behavioral: math
  • Behavioral: behavior regulation
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • age 6 years 9 months or older
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Months to 81 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00164229
Other Study ID Numbers  ICMJE CDC-NCBDDD-3721
U84ccu320162
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Centers for Disease Control and Prevention
Collaborators  ICMJE
  • Emory University
  • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  • Marcus Institute
Investigators  ICMJE
Principal Investigator: claire coles, PhD Marcus Institute
PRS Account Centers for Disease Control and Prevention
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP