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Early Characteristics of Autism

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
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
History of Changes
  Purpose

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 Intervention Phase
Autism
Autistic Disorder
 Behavioral: Intensive behavioral therapy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: UW STAART Center of Excellence

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: April 2003
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Months to 30 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of Washington

Additional 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: U54 MH66399, U54MH066399, DDTR BD-DD
Study First Received: August 26, 2004
Last Updated: June 15, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Autism
Developmental Delay Disorders

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013