Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2003-04-30
Brief Summary
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Detailed Description
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Children in this study will be enrolled for 2 years. They will receive annual evaluations throughout the two-year period. They will undergo a magnetic resonance imaging (MRI) scan and will complete various activities to determine brain functioning. In addition, children with autism will take part in intensive behavioral therapy at least 4 hours every day for the duration of the study. Communication and social behavior scales, an early development interview, observations of parent/child interaction, and neuropsychological, cognitive, and adaptive behavioral measures will be used to assess participants.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Child participants with autism will undergo intensive behavioral therapy.
Intensive behavioral therapy
Participants will undergo a magnetic resonance imaging (MRI) scan and will complete various activities to determine brain functioning. In addition, children with autism will take part in intensive behavioral therapy at least 4 hours every day for the duration of the study.
2
Child participants without autism will receive no treatment and will undergo assessments to determine brain functioning only.
No interventions assigned to this group
Interventions
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Intensive behavioral therapy
Participants will undergo a magnetic resonance imaging (MRI) scan and will complete various activities to determine brain functioning. In addition, children with autism will take part in intensive behavioral therapy at least 4 hours every day for the duration of the study.
Eligibility Criteria
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Inclusion Criteria
* Exhibiting current delays in development
* Exhibiting normal development
* Overall good health
18 Months
30 Months
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Aylward, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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References
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Dawson G, Rogers S, Munson J, Smith M, Winter J, Greenson J, Donaldson A, Varley J. Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model. Pediatrics. 2010 Jan;125(1):e17-23. doi: 10.1542/peds.2009-0958. Epub 2009 Nov 30.
Other Identifiers
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