Status:
COMPLETED
Clinical and Immunological Investigations of Subtypes of Autism
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Autism Spectrum Disorders
Seizures
Eligibility:
All Genders
1-7 years
Brief Summary
The purpose of this study is to learn more about autism and its subtypes. Autism is a developmental disorder in which children have problems with communication and social skills and display restricted...
Detailed Description
Objective: The current investigation focuses on finding meaningful subtypes of autism. Our objectives include using comprehensive and longitudinal medical assessments and behavioral testing to find s...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- There are 3 participant groups in this study.
- AUT: Children with autism (diagnosed with autistic disorder according to DSM-IV criteria). This group will include children that may be dichotomized as with regression and without regression.
- DD: Children with nonspectrum developmental delays
- TYP: Children deemed to be typically developing
- Accrual numbers are to include 140 children in the AUT group, 50 children in the DD group and 75 children in the TYP group.
- AUT: Children are included if they meet DSM-IV criteria for autistic disorder, based on ADI-R and ADOS and clinical judgment. Those meeting research criteria for autism will be included.
- Regression is defined as: Language loss: Loss of at least 3 spontaneously meaningful words (excluding mama or dada) used for at least a month, and lost for at least a month.AND/OR Nonverbal communication/social loss: Loss of more than one nonverbal communicative behavior (e.g. gestures, joint attention, eye contact, imagination, pretend play, sharing, showing, watching children, orienting to name, social smiling, social games, spontaneous imitation of actions, response to social overtures). Although there is overlap in the age period for regression specified in this protocol (regression between 15-30 months) and that described for childhood disintegrative disorder (CDD) (the DSM-IV criteria for indicate apparently normal development for the first 2 years after birth ), the criteria for CDD also indicate a diagnosis can only be made if symptoms are not better accounted for by another pervasive developmental disorder such as autism. Symptoms of CDD that separate it from autism include loss of acquired skills in areas such as motor skills and bowel or bladder control, while the focus of the current study is on regression in core symptoms of autism (i.e. socio-communicative skills). Thus, the currently protocol will include children with regression over 2 who meet criteria for autism, but not those who only meet criteria for CDD.
- DD: Developmental scores (Performance Quotient and Verbal Quotient) greater than 1.5 standard deviations below mean on Mullen Scales of Early Learning
- TYP: No diagnosis of developmental delay, and no first-degree relatives with a history of autism spectrum disorders.
- EXCLUSION CRITERIA:
- Diagnosis of cerebral palsy. For the typical controls only, a history of extremely low birth weight (due to prematurity or intrauterine growth failure).
- If behavioral management issues (e.g. self-injury, aggressiveness) are severe to the extent that the screening protocol was aborted.
Exclusion
Key Trial Info
Start Date :
February 22 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 15 2017
Estimated Enrollment :
557 Patients enrolled
Trial Details
Trial ID
NCT00298246
Start Date
February 22 2006
End Date
March 15 2017
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892