Autism Spectrum Disorders (ASD) are one of the most commonly occurring neuro- developmental disorders, affecting 1 in 68 children, frequently resulting in impairments in the functional skills necessary for independent living, and presenting a significant impact on families and society. Up to 90% of individuals with ASD present with difficulties processing and integrating sensory information and these have been shown to be a significant factor impacting functional skills. Intervention for these sensory issues is one of the most highly requested treatments. We have showed that children with ASD and sensory issues who were randomized to a 30-session Sensory Integration Treatment (SIT) made significant gains in functional skills, showed reduced sensory-related maladaptive behaviors, and improved their participation in daily activities compared to controls. Now that we have evidence in support of SIT for improvement of functional skills in this group of children with sensory issues, we seek to compare the effectiveness of SIT to focused behavioral strategies on improvement of functional skills for children with ASD and sensory issues ages 6-8.5 years of age. Importantly, we will interrogate the mechanisms of action and the phenotypic characteristics that predict response to intervention. After a comprehensive phenotypic assessment, eligible participants will be randomized to 30 one-hour sessions of SIT, ABA or No Treatment (NT). Outcome assessment, which includes behavioral and electrophysiological measures, will occur at baseline, post treatment and at 12 weeks following treatment to assess sustainability.
The specific aims of the study are to: 1) compare 30 session SIT to the same dosage of ABA to evaluate immediate and sustained changes in functional skills and maladaptive behaviors; 2) to assess whether the treatment regimen has differential effects on sensory processing and multisensory integration functions; and 3) to determine whether autism severity, cognitive level or severity of sensory symptoms moderate intervention outcomes. This study addresses multiple priorities of the Interagency Autism Coordinating Council's Strategic Plan for research including the need for comparative effectiveness RCTs of interventions for ASD, studies to uncover the biological mechanisms of ASD symptoms to aid in the development of customized, targeted interventions, identification of mediators or moderators of interventions, and treatment of core deficits. Findings will inform parents and providers about interventions that may best help improve functional skills based on phenotypic characteristics and symptoms. A team of inter-disciplinary researchers and clinicians with complementary expertise is utilized to address this unmet need.

Public Health Relevance

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 t 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, we 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.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Research Project (R01)
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Special Emphasis Panel (ZRG1)
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Kau, Alice S
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Albert Einstein College of Medicine, Inc
United States
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