Clinical trial NCT00164229: Fetal Alcohol Syndrome: Socio-Cognitive Habilitation
Official title: Study to Investigate the Effectiveness of a Math Intervention for Children With Fetal Alcohol Syndrome or Related Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fetal Alcohol Syndrome
Keywords: treatment
control
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Emory University
name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Marcus Institute
First posted: 2005-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 42
Maximum age (years): 81
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: math knowledge
measure: math skills
Secondary outcomes:
measure: behavior regulation
measure: parent knowledge of FAS
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Marcus Institute
state: Georgia
Study officials:
affiliation: Marcus Institute
name: claire coles, PhD
role: PRINCIPAL_INVESTIGATOR
References: