Identification of Characteristics Associated With Symptom Remission in Autism

NCT00938054 | Completed

• 2 other identifiers: 09017109-M-0171
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Autism Spectrum Disorders; Autism

Keywords

Outcome; Autism; Pervasive Developmental Disorder

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• STUDY SUBJECTS:
• 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
• 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
• measure of cognitive ability from within 1 year of initial autism diagnosis
• 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
• initial diagnosis of autism prior to age 6
• AND
• 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
• 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
• 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
• 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.

You may not qualify if:

• All groups: May not be pregnant or have a known genetic disorder, mitochondrial disease, history of birth trauma, or current uncontrolled seizures
• TD Group:
• Current diagnosis or significant history of pervasive developmental disorder, language delay or disorder (except articulation), attention or learning issues, or major psychiatric condition.
• Prematurity at birth less than 36 weeks gestation); or birth weight significantly below normal for gestational age (SGA- small for gestational age).
• PARENTS OF ALL STUDY PARTICIPANTS:
• As noted parents of all study groups will provide DNA, plasma, and serum samples.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Abrahams BS, Geschwind DH. Advances in autism genetics: on the threshold of a new neurobiology. Nat Rev Genet. 2008 May;9(5):341-55. doi: 10.1038/nrg2346.

  PMID: 18414403 BACKGROUND

• Bibby P, Eikeseth S, Martin NT, Mudford OC, Reeves D. Progress and outcomes for children with autism receiving parent-managed intensive interventions. Res Dev Disabil. 2002 Jan-Feb;23(1):81-104. doi: 10.1016/s0891-4222(02)00095-1.

  PMID: 12071397 BACKGROUND

• Boyd RD, Corley MJ. Outcome survey of early intensive behavioral intervention for young children with autism in a community setting. Autism. 2001 Dec;5(4):430-41. doi: 10.1177/1362361301005004007.

  PMID: 11777258 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Child Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Susan E Swedo, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 13, 2009
• Study Start: June 25, 2009
• Study Completion: October 9, 2012
• Last Updated: October 6, 2017

Record last verified: 2012-10-09

Locations

US (1)