Early Characteristics of Autism

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00090415
First received: August 26, 2004
Last updated: June 15, 2012
Last verified: June 2012

August 26, 2004
June 15, 2012
April 2003
April 2008   (final data collection date for primary outcome measure)
Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00090415 on ClinicalTrials.gov Archive Site
Not Provided
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Early Characteristics of Autism
UW STAART Center of Excellence

This study will identify factors that distinguish children with autism from children with developmental delay and those with normal development and study the efficacy of intensive behavioral therapy in children with autism.

Children with autism often suffer from social, educational, and functional problems. By understanding the social, linguistic, psychological, and physiological differences that distinguish between autistic children, developmentally delayed children, and children with typical development, researchers may be able to recognize autism early in life so that children with autism can be helped as early as possible and their long-term outcome can be improved.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Autism
  • Autistic Disorder
Behavioral: 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.
  • Experimental: 1
    Child participants with autism will undergo intensive behavioral therapy.
    Intervention: Behavioral: Intensive behavioral therapy
  • No Intervention: 2
    Child participants without autism will receive no treatment and will undergo assessments to determine brain functioning only.
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. Epub 2009 Nov 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
Not Provided
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria for Autistic Participants:

  • Diagnosis of autism

Inclusion Criteria for Developmentally Delayed Participants:

  • Exhibiting current delays in development

Inclusion Criteria for Participants with Normal Development:

  • Exhibiting normal development

Inclusion Criteria for All Participants:

  • Overall good health
Both
18 Months to 30 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00090415
U54 MH66399, U54MH066399, DDTR BD-DD
No
University of Washington
University of Washington
National Institute of Mental Health (NIMH)
Principal Investigator: Elizabeth Aylward, PhD University of Washington
University of Washington
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP