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NCT00164346 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Centers for Disease Control and Prevention.

Completed
Registry status
Phase 1
Development phase
100
Enrollment target

NCT00164346: Completed Phase 1 study, sponsored by Centers for Disease Control and Prevention.

NCT00164346 is a Phase 1 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00164346, a Phase 1 study, has completed, sponsored by Centers for Disease Control and Prevention.

COMPLETED
Registry status
Phase 1
Development phase
100 participants
Enrollment target

Study 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.

Interventions

  • BEHAVIORAL neurocognitive habilitation

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2002-01
Est. Completion 2009-12
Phase Phase 1

What the finished NCT00164346 record still lists

NCT00164346 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).

The record links to 0 conditions, and to 1 intervention - of which neurocognitive habilitation is the first listed.

NCT00164346 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00164346 about?

NCT00164346 is a clinical study titled "Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome (FAS)/Alcohol-Related Neurodevelopmental Disorder (ARND)". 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 ...

What is the current status of trial NCT00164346?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2002-01. Estimated completion is 2009-12.

What interventions are being tested in trial NCT00164346?

The interventions under investigation include: neurocognitive habilitation (BEHAVIORAL).

Who is sponsoring clinical trial NCT00164346?

This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00164346's enrollment target sits among peer trials

100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00164346, the US trial registry maintained by the National Library of Medicine. NCT00164346 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.