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Trial record 1 of 4 for:    19948568 [PUBMED-IDS]
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Early Characteristics of Autism

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ClinicalTrials.gov Identifier: NCT00090415
Recruitment Status : Completed
First Posted : August 27, 2004
Last Update Posted : June 19, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Autistic Disorder Behavioral: Intensive behavioral therapy Phase 1

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: UW STAART Center of Excellence
Study Start Date : April 2003
Actual Primary Completion Date : April 2008

Arm Intervention/treatment
Experimental: 1
Child participants with autism will undergo intensive behavioral therapy.
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.
No Intervention: 2
Child participants without autism will receive no treatment and will undergo assessments to determine brain functioning only.



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090415


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Elizabeth Aylward, PhD University of Washington

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00090415     History of Changes
Other Study ID Numbers: U54MH066399 ( U.S. NIH Grant/Contract )
DDTR BD-DD
First Posted: August 27, 2004    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by University of Washington:
Autism
Developmental Delay Disorders

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders