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| Sponsors and Collaborators: |
Centers for Disease Control and Prevention Children's Research Triangle |
| Information provided by: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00164346 |
Purpose
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.
| Condition | Intervention | Phase |
|
Fetal Alcohol Syndrome Alcohol-Related Neurodevelopmental Disorder |
Behavioral: neurocognitive habilitation |
Phase I Phase II |
| MedlinePlus related topics: | Fetal Alcohol Syndrome |
| Drug Information available for: | Ethanol |
| Study Type: | Interventional |
| Study Design: | Other, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Neurocognitive Habilitation for Children With FAS/ARND |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2002 |
| Estimated Study Completion Date: | December 2009 |
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:
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.
Eligibility
| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contacts and Locations| United States, Illinois | |||||
| Children's Research Triangle | |||||
| Chicago, Illinois, United States, 60601 | |||||
| Centers for Disease Control and Prevention |
| Children's Research Triangle |
| Principal Investigator: | Ira Chasnoff, MD | Children's Research Triangle |
More Information
| Study ID Numbers: | CDC-NCBDDD-3710, U84/CCU520164-01 |
| First Received: | September 9, 2005 |
| Last Updated: | September 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00164346 |
| Health Authority: | United States: Federal Government |
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