NCT00164346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 24, 2011

Status Verified

March 1, 2011

Enrollment Period

6.7 years

First QC Date

September 9, 2005

Last Update Submit

March 23, 2011

Conditions

Fetal Alcohol SyndromeAlcohol-related Neurodevelopmental Disorder

Keywords

fetal alcohol syndrome (FAS)alcohol-related neurodevelopmental disorder (ARND)

Outcome Measures

Primary Outcomes (1)

  • foster care placement stability

Interventions

neurocognitive habilitationBEHAVIORAL

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6 to 12 years
  • Children in the care of Illinois foster care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Research Triangle

Chicago, Illinois, 60601, United States

Location

Related Publications (2)

  • 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.

    PMID: 22251828DERIVED

  • 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.

    PMID: 20375733DERIVED

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Ira Chasnoff, MD

    Children's Research Triangle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

January 1, 2002

Primary Completion

September 1, 2008

Study Completion

December 1, 2009

Last Updated

March 24, 2011

Record last verified: 2011-03

Locations

US(1)