NCT00164229

Brief Summary

Comprehensive evaluation (geneticist, psychologist, social worker, education specialist, others as indicated) to determine individual needs and treatment plan. Referrals for specific services (e.g., OT, counseling, medications, etc) will be to clinicians within the families' own communities. All families will receive evaluation, parent education/advocacy, and learning readiness program. Only the intervention group will receive the math intervention.

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 Oct 2001

Typical duration 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

October 1, 2001

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
8 months 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
Last Updated

April 28, 2008

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

April 25, 2008

Conditions

Fetal Alcohol Syndrome

Keywords

treatmentcontrol

Outcome Measures

Primary Outcomes (2)

  • math knowledge

  • math skills

Secondary Outcomes (2)

  • behavior regulation

  • parent knowledge of FAS

Interventions

mathBEHAVIORAL
behavior regulationBEHAVIORAL

Eligibility Criteria

Age42 Months - 81 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • diagnosis of FAS or related condition
  • age 3 years six month or older

You may not qualify if:

  • age 6 years 9 months or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marcus Institute

Atlanta, Georgia, 30333, United States

Location

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

  • claire coles, PhD

    Marcus Institute

    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

October 1, 2001

Study Completion

January 1, 2005

Last Updated

April 28, 2008

Record last verified: 2005-09

Locations

US(1)