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NCT00938054 · ClinicalTrials.gov registry record

Identification of Characteristics Associated With Symptom Remission in Autism

A clinical trial, sponsored by National Institute of Mental Health (NIMH).

Completed
Registry status
37
Enrollment target

NCT00938054: Completed study, sponsored by National Institute of Mental Health (NIMH).

NCT00938054 is a clinical trial that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 37 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00938054 has completed, sponsored by National Institute of Mental Health (NIMH).

COMPLETED
Registry status
37 participants
Enrollment target

Study Summary

Autism is defined as a lifelong pervasive developmental disability, as such, symptom recovery is considered rare. Reports by Lovaas and McEachin, Smith \& Lovaas and more recently by Cohen, Amerine-Dickens, \& Smith, Smith Groen et al. and Sutera Pandey et al suggest that intensive behavioral intervention programs during preschool years may result in improvement to the point where some children no longer meet criteria for autism by the time they reach school age. Similarly, there are a large number of anecdotal reports of children with autism who, following intensive biomedical intervention (e.g., gluten/casein free diets, vitamin supplements, chelation), are indistinguishable from their typically developing peers. The goal of the current research is to characterize the behavioral and biological profiles of children with autism who show significant symptom reduction such that they no longer meet criteria for autism (Remitted Autism \[REM-AUT\]) and to contrast them with a group of children who continue to meet criteria for autism (AUT) and to typically developing (TD) group of children. Examining whether neurobiological and neurobehavioral symptoms commonly reported in autism are as frequent and severe in children who have responded to treatment is an important first step in determining what factors may contribute to symptom remission in autism. In addition, understanding how children with remitted autism compare to typically developing children will help us better understand whether symptom improvement is through remediation (normalization of function) or compensation (achieving the same behavioral/adaptive outcome but through an alternative process).

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2009-06-25
Est. Completion 2012-10-09

What the finished NCT00938054 record still lists

NCT00938054 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 37 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00938054 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00938054 about?

NCT00938054 is a clinical study titled "Identification of Characteristics Associated With Symptom Remission in Autism". Autism is defined as a lifelong pervasive developmental disability, as such, symptom recovery is considered rare. Reports by Lovaas and McEachin, Smith \& Lovaas and more recently by Cohen, Amerine-Dickens, \& Smith, Smith Groen et al. and Sutera Pandey et al suggest that intensive behavioral interv...

What is the current status of trial NCT00938054?

This trial is currently completed. The enrollment target is 37 participants. The study started on 2009-06-25. Estimated completion is 2012-10-09.

Who is sponsoring clinical trial NCT00938054?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00938054, the US trial registry maintained by the National Library of Medicine. NCT00938054 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.