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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00938054 |
Purpose
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)....
| Condition |
|---|
|
Autism Spectrum Disorders Autism |
| Study Type: | Observational |
| Official Title: | Identification of Characteristics Associated With Symptom Remission in Autism |
| Estimated Enrollment: | 145 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
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).
Eligibility| Ages Eligible for Study: | 8 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Remitted Autism (REM-AUT) Group:
Diagnosis of autism prior to symptom improvement
valid administration of ADI and/or ADOS with accompanying interpretive report yielding an autism diagnosis
OR
initial diagnosis of autism prior to age 6
AND
Current functioning:
a. Parent report and report of at least one professional that child is no longer autistic
At screening visit (after meeting initial eligibility), will not meet criteria for autism
Minimum improvement of symptoms required from group assignment: approximately 2 point CGI severity of illness change (or equivalent) based on PDN impression of change in illness severity from initial diagnosis (estimated based on review of past medical records) and current functioning
OR
AUTISM Group:
TD Group:
EXCLUSION CRITERIA:
All groups: May not be pregnant or have a known genetic disorder, mitochondrial disease, history of birth trauma, or current uncontrolled seizures
TD Group:
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 090171, 09-M-0171 |
| Study First Received: | July 10, 2009 |
| Last Updated: | October 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00938054 History of Changes |
| Health Authority: | United States: Federal Government |
|
Outcome Autism Autism Pervasive Developmental Disorder |
|
Child Development Disorders, Pervasive Mental Disorders Autistic Disorder Mental Disorders Diagnosed in Childhood |