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Fetal Alcohol Syndrome: Socio-Cognitive Habilitation

Study to Investigate the Effectiveness of a Math Intervention for Children With Fetal Alcohol Syndrome or Related Condition

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00164229
Enrollment
100
Registered
2005-09-14
Start date
2001-10-31
Completion date
2005-01-31
Last updated
2008-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Alcohol Syndrome

Keywords

treatment, control

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.

Interventions

BEHAVIORALmath
BEHAVIORALbehavior regulation

Sponsors

Emory University
CollaboratorOTHER
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
CollaboratorOTHER
Marcus Institute
CollaboratorUNKNOWN
Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
42 Months to 81 Months
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

Design outcomes

Primary

MeasureTime frame
math knowledge
math skills

Secondary

MeasureTime frame
behavior regulation
parent knowledge of FAS

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026