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

Fetal Alcohol Syndrome Clinical Trial

Official title:

Neurocognitive Habilitation for Children With FAS/ARND

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164346
• Other study ID #: CDC-NCBDDD-3710
• Secondary ID: U84/CCU520164-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 9, 2005
• Last updated: March 23, 2011
• Start date: January 2002
• Est. completion date: December 2009

Study information

• Verified date: March 2011
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children aged 6 to 12 years

• Children in the care of Illinois foster care

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Alcohol-related Neurodevelopmental Disorder
• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• Mental Disorders Diagnosed in Childhood

Intervention

Behavioral:
• neurocognitive habilitation

Locations

Country	Name	City	State
United States	Children's Research Triangle	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Children's Research Triangle

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	foster care placement stability