Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome (FAS)/Alcohol-Related Neurodevelopmental Disorder (ARND)
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|ClinicalTrials.gov Identifier: NCT00164346|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : March 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Fetal Alcohol Syndrome Alcohol-related Neurodevelopmental Disorder||Behavioral: neurocognitive habilitation||Phase 1 Phase 2|
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:
- neurocognitive exercises (relaxation);
- specific topic discussions; and
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Neurocognitive Habilitation for Children With FAS/ARND|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||December 2009|
- foster care placement stability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164346
|United States, Illinois|
|Children's Research Triangle|
|Chicago, Illinois, United States, 60601|
|Principal Investigator:||Ira Chasnoff, MD||Children's Research Triangle|