School- and Home-Based Early Intervention for Toddlers With Autism

July 3, 2013 updated by: Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion

This study will determine the impact of early intervention on the communication and social development of toddlers with autism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Autism is a condition that affects brain development, often leading to difficulties in social, emotional, and educational functioning. This study will determine whether early intervention can improve such functioning in toddlers with autism.

Each treatment session will last 6 months. Children with an autism spectrum disorder will be enrolled in one of two parallel classes and will receive one of two treatments 4 days a week for the duration of the session. Children in each class will receive the same amount and level of intervention, but with a different goal focus. Treatments will be school- and home-based; parents will receive instruction on administering the at-home part of the treatment. The intervention will include environmental engineering, developmental approaches, adaptations of traditional behavioral approaches, and contemporary behavioral approaches that apply principles of applied behavior analysis in more naturalistic teaching frameworks. A series of measures including scales, interviews, and observations will be used to assess the children at baseline, study completion, and 6 months after study completion. The children will be videotaped during the school-based intervention.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21211
        • Kennedy Krieger Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of autism spectrum disorder
  • Parent or guardian willing to give informed consent for child's participation
  • Developmental level above 9 months on the Visual Reception Scale of the Mullen Scales of Early Learning and on the Adaptive Behavior Composite of the Vineland Adaptive Behavior Scales
  • English is primary language for child and family

Exclusion Criteria:

  • Evidence of vision or hearing impairment
  • Diagnosis of fragile X syndrome, Rett syndrome, tuberous sclerosis, neurofibromatosis, phenylketonuria, or congenital rubella
  • History of severe birth trauma or traumatic brain injury
  • Siblings with autism spectrum disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Behavioral Intervention (experimental)
Behavioral: Early intervention blending several tx approaches, w/ focus
Early intervention blending several different treatment approaches, with a focus on certain skills
Active Comparator: 2
Behavioral Intervention 2
Behavioral: Early intervention blending several treatment approaches
Early intervention blending several different treatment approaches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Receptive language skills
Time Frame: Pre-tx, Post-tx, and 6 month follow up
Pre-tx, Post-tx, and 6 month follow up
Expressive language skills
Time Frame: Pre-tx, Post-tx, and 6 month follow up
Pre-tx, Post-tx, and 6 month follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Social cognitive skills
Time Frame: Pre-tx, Post-tx, and 6 month follow up
Pre-tx, Post-tx, and 6 month follow up
Social emotional functioning
Time Frame: Pre-tx, Post-tx, and 6 month follow up
Pre-tx, Post-tx, and 6 month follow up
Play skills
Time Frame: Pre-tx, Post-tx, and 6 month follow up
Pre-tx, Post-tx, and 6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Rebecca Landa, PhD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

March 21, 2005

First Submitted That Met QC Criteria

March 21, 2005

First Posted (Estimate)

March 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 8, 2013

Last Update Submitted That Met QC Criteria

July 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U54MH066417 (U.S. NIH Grant/Contract)
  • DDTR BD-DD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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