NCT00090415

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2004

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

5 years

First QC Date

August 26, 2004

Last Update Submit

June 15, 2012

Conditions

AutismAutistic Disorder

Keywords

AutismDevelopmental Delay Disorders

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Child participants with autism will undergo intensive behavioral therapy.

Behavioral: Intensive behavioral therapy

2

NO INTERVENTION

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

Interventions

Intensive behavioral therapyBEHAVIORAL

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.

1

Eligibility Criteria

Age18 Months - 30 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of autism
  • Exhibiting current delays in development
  • Exhibiting normal development
  • Overall good health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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.

    PMID: 19948568DERIVED

MeSH Terms

Conditions

Autistic DisorderDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Elizabeth Aylward, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2004

First Posted

August 27, 2004

Study Start

April 1, 2003

Primary Completion

April 1, 2008

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations

US(1)