Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome (FAS)/Alcohol-Related Neurodevelopmental Disorder (ARND)

Sponsor
Centers for Disease Control and Prevention (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00164346
Collaborator
Children's Research Triangle (Other)
100
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95
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: neurocognitive habilitation
Phase 1/Phase 2

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:

  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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Official Title:
Neurocognitive Habilitation for Children With FAS/ARND
Study Start Date :
Jan 1, 2002
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Dec 1, 2009

Outcome Measures

Primary Outcome Measures

  1. foster care placement stability []

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Children aged 6 to 12 years

  • Children in the care of Illinois foster care

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Research Triangle Chicago Illinois United States 60601

Sponsors and Collaborators

  • Centers for Disease Control and Prevention
  • Children's Research Triangle

Investigators

  • Principal Investigator: Ira Chasnoff, MD, Children's Research Triangle

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00164346
Other Study ID Numbers:
  • CDC-NCBDDD-3710
  • U84/CCU520164-01
First Posted:
Sep 14, 2005
Last Update Posted:
Mar 24, 2011
Last Verified:
Mar 1, 2011

Study Results

No Results Posted as of Mar 24, 2011