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

This study has been completed.
Sponsor:
Collaborator:
Children's Research Triangle
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164346
First received: September 9, 2005
Last updated: March 23, 2011
Last verified: March 2011
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Neurocognitive Habilitation for Children With FAS/ARND

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • foster care placement stability

Estimated Enrollment: 100
Study Start Date: January 2002
Study Completion Date: December 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children aged 6 to 12 years
  • Children in the care of Illinois foster care
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164346

Locations
United States, Illinois
Children's Research Triangle
Chicago, Illinois, United States, 60601
Sponsors and Collaborators
Children's Research Triangle
Investigators
Principal Investigator: Ira Chasnoff, MD Children's Research Triangle
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jacquelyn Bertrand, CDC
ClinicalTrials.gov Identifier: NCT00164346     History of Changes
Other Study ID Numbers: CDC-NCBDDD-3710, U84/CCU520164-01
Study First Received: September 9, 2005
Last Updated: March 23, 2011
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
fetal alcohol syndrome (FAS)
alcohol-related neurodevelopmental disorder (ARND)

Additional relevant MeSH terms:
Fetal Alcohol Syndrome
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 24, 2014