Early Characteristics of Autism

Autism Clinical Trial

Official title:

UW STAART Center of Excellence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090415
• Other study ID #: U54MH066399
• Secondary ID: U54MH066399DDTR
• Status: Completed
• Phase: Phase 1
• First received: August 26, 2004
• Last updated: June 15, 2012
• Start date: April 2003

Study information

• Verified date: June 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 30 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures		Measured at Year 2	No