Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Autism
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 6102 years
Gender
Both males and females

Description

Autism Spectrum Disorders (ASD) are among the most common neurodevelopmental disorder with estimated costs of treatment across the lifespan of $3.2 million. A common feature of ASD is over or under sensitivity to the environment and difficulty putting sensory information together in an orderly way, ...

Autism Spectrum Disorders (ASD) are among the most common neurodevelopmental disorder with estimated costs of treatment across the lifespan of $3.2 million. A common feature of ASD is over or under sensitivity to the environment and difficulty putting sensory information together in an orderly way, referred to here as sensory issues. Such sensory issues are now included in the diagnostic criteria in the DSM5 under the Restrictive and Repetitive Behaviors and Interests Criteria. These sensory issues have a deleterious effect on functional skills and limit participation in work, education, and social activities for individuals with ASD and their family. Building on previous work, this study seeks to extend understanding of Sensory Integration Therapy (SIT) as a non-invasive intervention to improve functional skills in children with ASD and sensory issues, and to test its efficacy in comparison to commonly used applied behavioral treatments. Further, the investigators will explore the proposed neurobiological mechanisms by which this intervention may work, and phenotypic moderators of outcome. This study utilizes a randomized trial to compare SIT to a commonly used behavioral intervention to evaluate outcomes on functional skills as a basis for improved independence over the lifetime. A total of 180 children with ASD and sensory issues in the greater New York City Metropolitan area will complete this study.

Tracking Information

NCT #
NCT02536365
Collaborators
  • Thomas Jefferson University
  • Queens College, The City University of New York
Investigators
Principal Investigator: Sophie Molholm, Ph.D. Principal Investigator