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Early Characteristics of Autism

Primary Purpose

Autism, Autistic Disorder

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Intensive behavioral therapy

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, Developmental Delay Disorders

Eligibility Criteria

18 Months - 30 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

Child participants with autism will undergo intensive behavioral therapy.

Child participants without autism will receive no treatment and will undergo assessments to determine brain functioning only.

Outcomes

Primary Outcome Measures

Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00090415

First Posted

August 26, 2004

Last Updated

June 15, 2012

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00090415

Brief Title

Early Characteristics of Autism

Official Title

UW STAART Center of Excellence

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism, Autistic Disorder

Keywords

Autism, Developmental Delay Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Child participants with autism will undergo intensive behavioral therapy.

Arm Title

Arm Type

No Intervention

Arm Description

Child participants without autism will receive no treatment and will undergo assessments to determine brain functioning only.

Intervention Type

Behavioral

Intervention Name(s)

Intensive behavioral therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Months

Maximum Age & Unit of Time

30 Months

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Aylward, PhD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19948568

Citation

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.

Results Reference

derived

Learn more about this trial

Early Characteristics of Autism

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