- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00164346
Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome (FAS)/Alcohol-Related Neurodevelopmental Disorder (ARND)
Neurocognitive Habilitation for Children With FAS/ARND
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60601
- Children's Research Triangle
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children aged 6 to 12 years
- Children in the care of Illinois foster care
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
foster care placement stability
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ira Chasnoff, MD, Children's Research Triangle
Publications and helpful links
General Publications
- Wells AM, Chasnoff IJ, Schmidt CA, Telford E, Schwartz LD. Neurocognitive habilitation therapy for children with fetal alcohol spectrum disorders: an adaptation of the Alert Program(R). Am J Occup Ther. 2012 Jan-Feb;66(1):24-34. doi: 10.5014/ajot.2012.002691.
- Chasnoff IJ, Wells AM, Telford E, Schmidt C, Messer G. Neurodevelopmental functioning in children with FAS, pFAS, and ARND. J Dev Behav Pediatr. 2010 Apr;31(3):192-201. doi: 10.1097/DBP.0b013e3181d5a4e2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCBDDD-3710
- U84/CCU520164-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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