NCT00004449

Brief Summary

OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in the home or neighborhood compared with at home, individualized, parent training in preschool aged children with autism. II. Identify intake measures that predict differences in outcome between subjects in the experimental group.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 1998

Longer than P75 for not_applicable

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

May 1, 1998

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

6.3 years

First QC Date

October 18, 1999

Last Update Submit

May 26, 2015

Conditions

Autistic Disorder

Keywords

autismneurologic and psychiatric disordersrare disease

Outcome Measures

Primary Outcomes (2)

  • Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.

    IQ

    yearly for up to 4 years

  • Bayley Scales of Infant Development

    Alternate cognitive test administered to participants who did not achieve basal on WPPSI-III

    yearly for up to 4 years

Secondary Outcomes (3)

  • Merrill-Palmer Scale of Mental Tests

    yearly for up to 4 years

  • Reynell Developmental Language Scales

    yearly for up to 4 years

  • Vineland Adaptive Behavior Scales - Survey Edition

    yearly for up to 4 years

Interventions

intensive one-on-one behavioral treatmentBEHAVIORAL

Up to 40 hours per week of one-to-one intervention based on applied behavior analysis

Individualized in home parent trainingBEHAVIORAL

Offered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention

Eligibility Criteria

Age2 Years - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Disease Characteristics--
  • Diagnosis of autism based on the Autism Diagnostic Interview using the ICD-10 research criteria
  • Ratio IQ score greater than 35 determined from the Bayley Scales of Infant Development
  • Patient Characteristics--
  • Other:
  • Must reside within 60 km (37.5 miles) of a treatment site

You may not qualify if:

  • Severe medically induced limitations defined as:
  • Any condition requiring prosthetic devices (e.g., blindness, deafness, or cerebral palsy)
  • Any illness that has prevented or would prevent a subject from participating in 30 hours a week of treatment for six consecutive weeks or more (e.g., metastasized cancer or end stage renal disease)
  • Any known genetic disorder (e.g., Fragile X, PKU, or Down Syndrome)
  • Any other disorder that rules out autism according to ICD-10 criteria (e.g., Rett's Syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Cohen H, Amerine-Dickens M, Smith T. Early intensive behavioral treatment: replication of the UCLA model in a community setting. J Dev Behav Pediatr. 2006 Apr;27(2 Suppl):S145-55. doi: 10.1097/00004703-200604002-00013.

    PMID: 16685181RESULT

  • Sallows GO, Graupner TD. Intensive behavioral treatment for children with autism: four-year outcome and predictors. Am J Ment Retard. 2005 Nov;110(6):417-38. doi: 10.1352/0895-8017(2005)110[417:IBTFCW]2.0.CO;2.

    PMID: 16212446RESULT

  • Hayward D, Eikeseth S, Gale C, Morgan S. Assessing progress during treatment for young children with autism receiving intensive behavioural interventions. Autism. 2009 Nov;13(6):613-33. doi: 10.1177/1362361309340029.

    PMID: 19933766RESULT

MeSH Terms

Conditions

Autistic DisorderNeurologic ManifestationsMental DisordersRare Diseases

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Tristram Smith, Ph.D.

    University of Rochester

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

May 1, 1998

Primary Completion

September 1, 2004

Study Completion

April 1, 2006

Last Updated

May 27, 2015

Record last verified: 2015-05