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View Clinical Trial (Medical Research Study)
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Identification of Characteristics Associated With Symptom Remission in Autism - NCT00938054-20892 (Clinical Trial 301566)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy301566.aspx
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Autism Spectrum Disorders - Autism |
| Purpose: |
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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)....
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| Study summary: |
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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). |
| Criteria: |
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- INCLUSION CRITERIA:
Remitted Autism (REM-AUT) Group:
1. Diagnosis of autism prior to symptom improvement
1. valid administration of ADI and/or ADOS with accompanying interpretive report
yielding an autism diagnosis
OR
2. clinical/developmental evaluation including a detailed review of the child's
history and direct observation of current behavioral functioning resulting in a
documented diagnosis of autism by a child developmental specialist experienced
with autism spectrum disorders such as a developmental pediatrician,
developmental psychologist, child clinical psychologist, or a child psychiatrist
3. measure of cognitive ability from within 1 year of initial autism diagnosis
4. objective measure indicative of prominent autism symptoms using a recognized and
standardized assessment of autism symptoms such as the Social Responsiveness
Scale (SRS), Childhood Autism Rating Scale (CARS), or the Modified Checklist for
Autism in Toddlers (MCHAT) or video tapes of assessments
5. initial diagnosis of autism prior to age 6
AND
6. Medical, educational, treatment record review by PDN branch clinicians to
confirm diagnostic impressions including a detailed description of child's
behaviors that support an autism diagnosis
7. The final decision for meeting diagnostic and treatment history inclusion
criteria is based on PDN branch staff review of the case
8. Treatment history: all participants must have received adequate treatment
intervention for their autism symptoms. Participant medical and treatment
records will be carefully reviewed to ascertain their treatment history
2. Current functioning:
a. Parent report and report of at least one professional that child is no longer
autistic
3. At screening visit (after meeting initial eligibility), will not meet criteria for
autism
1. Must not meet criteria for autism per overall clinical impression based on
information collected from administration of the ADOS, current ADI-R symptoms,
and other clinical observations made the assessment.
2. Teacher/informant report of autism symptoms (such as results from the SRS) not
indicative of autism diagnosis
3. 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
4. Current assessment of functional impairment due to autism symptoms using a
standardized assessment measure such as the Developmental Disability-Children's
Global Assessment Scale will reflect adequate functioning in all areas and/or a
clinically significant improvement in functioning, consistent with common
psychiatric treatment definitions for treatment response
4. Able to participate in study procedures.
AUTISM Group:
1. Diagnosis of autism following the same criteria as described above
2. Treatment history: all study participants must have received adequate treatment
intervention. Treatment history will be matched to treatment provided to children in
the REM-AUT group.
3. Screening visit (after meeting initial eligibility): will meet criteria for autistic
disorder using the same diagnostic process described for the REM-AUT group above
4. Matched to REM-AUT group on IQ, age of diagnosis, and treatment history. IQ matching
between the AUT and REM-AUT groups will be based on pretreatment estimates of
cognitive level obtained from the medical record review.
5. Able to participate in study procedures.
TD Group:
1. IQ matched to a sub-sample of children in the REM-AUT group with normal range
intellectual functioning. IQ matching between the TD and REM-AUT groups will be
based on current intellectual functioning at the time of study participation.
2. Able to participate in study procedures.
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:
1. Current diagnosis or significant history of pervasive developmental disorder,
language delay or disorder (except articulation), attention or learning issues, or
major psychiatric condition.
2. Prematurity at birth less than 36 weeks gestation); or birth weight significantly
below normal for gestational age (SGA- small for gestational age). |
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| Study is available at: |
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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