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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00164346
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : March 24, 2011
Children's Research Triangle
Information provided by:
Centers for Disease Control and Prevention

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
Fetal Alcohol Syndrome Alcohol-related Neurodevelopmental Disorder 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. foster care placement stability

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00164346

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United States, Illinois
Children's Research Triangle
Chicago, Illinois, United States, 60601
Sponsors and Collaborators
Centers for Disease Control and Prevention
Children's Research Triangle
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Principal Investigator: Ira Chasnoff, MD Children's Research Triangle
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jacquelyn Bertrand, CDC Identifier: NCT00164346    
Other Study ID Numbers: CDC-NCBDDD-3710
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: March 2011
Keywords provided by Centers for Disease Control and Prevention:
fetal alcohol syndrome (FAS)
alcohol-related neurodevelopmental disorder (ARND)
Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Neurodevelopmental Disorders
Pathologic Processes
Mental Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders