Fetal Alcohol Syndrome Clinical Trial
Official title:
Neurocognitive Habilitation for Children With FAS/ARND
Children will receive comprehensive evaluations through the Children's Research Triangle (CRT) clinical program. The assessment for the child will be in accordance with the protocol developed by Astley and Clarren as performed by one of the clinic pediatricians and final diagnosis will be according to Institute of Medicine (IOM) criteria. Children will be randomized into either a Treatment or Control group. The Treatment group will receive (in addition to standard referrals) neurocognitive habilitation and psychotherapy services as well as parent psychoeducation. The Control group will be referred for intervention through existing community and school-based agencies.
Neurocognitive habilitation, based on the traumatic brain injury literature for teaching
compensatory skills, will be the primary intervention. Interventions will be individually
designed and delivered through individual therapy sessions. Audiotapes will augment the
sessions to facilitate implementation of strategies in the home environment. Didactic
therapy will be used to foster appropriate interactions and relationships between parent and
child. Children will participate in 8-week group sessions that will include neurocognitive
exercises, homework sessions, and possibly group psychotherapy. An educational specialist
will provide school and legal advocacy services as well as observations of the child in the
classroom that could lead to educational modifications.
Parent Component: Family education programs and parent support groups using
psychoeducational approaches will be the means of intervening with parent behaviors. Parents
will be instructed on becoming advocates for their child. Groups of 8 to 12 parents will
meet for one 2-hour session per week for 8 weeks. Each session will include:
1. neurocognitive exercises (relaxation);
2. specific topic discussions; and
3. general support.
During the last hour of the final two weeks of the program, parent and children will be
combined to practice learned techniques. Children and parents will participate in monthly
"booster" sessions.
Evaluation Plan: Treatment and control groups will be compared using pre- and post-test
measures. Post-tests will be at the conclusion of the intervention, as well as at 12, and
24-month follow-ups. Process and outcome measures will be evaluated.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind
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