Sensory Integration Therapy in Autism: Mechanisms and Effectiveness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2022-10-15

Brief Summary

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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. Building on previous work, this study will test the efficacy of Sensory Integration Therapy (SIT), a non-invasive intervention to improve functional skills in children with ASD, in comparison to commonly applied ABA behavioral treatments, in the treatment of ASD symptoms. A total of 180 children with ASD and sensory issues in the greater New York City Metropolitan area will complete this study.

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Detailed Description

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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.

Conditions

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Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Sensory Integration Therapy

Children receive manualized SIT intervention that follows principles of sensory integration. SIT directly addresses the specific sensory factors hypothesized to underlie the child's functional skills difficulties and follows the Data Driven Decision Making Process, to tailor the intervention to the child's specific sensory issues.

Group Type EXPERIMENTAL

Sensory Integration Therapy

Intervention Type BEHAVIORAL

Children in the SIT treatment group will receive a manualized SIT intervention that follows the principles of sensory integration.

Applied Behavioral Analysis

This involves examination of environmental variables that influence behavior and altering those variables to improve the child's skills. Intervention is individualized based on identified needs of the child, assessment of environmental variables impacting their performance of specific functional skills, and their abilities.

Group Type ACTIVE_COMPARATOR

Applied Behavioral Analysis

Intervention Type BEHAVIORAL

Children in the ABA treatment group will receive intervention that follows the principles of Applied Behavioral Analysis.

No Treatment

Treatment as usual will occur through the treatment period. As with the other treatment conditions, the participant agrees to refrain from beginning new treatments during participation in this study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sensory Integration Therapy

Children in the SIT treatment group will receive a manualized SIT intervention that follows the principles of sensory integration.

Intervention Type BEHAVIORAL

Applied Behavioral Analysis

Children in the ABA treatment group will receive intervention that follows the principles of Applied Behavioral Analysis.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Between the ages of 6.0 and 9.5 at the time of enrollment
2. Have a diagnosis of ASD that is confirmed by our research certified licensed psychologist based on clinical impression, DSM-5 criteria, and cut off scores from the Autism Diagnostic Schedule -2 (ADOS) (or CARS; an adjustment made as a consequence of pandemic) and the Autism Diagnostic Interview - Revised (ADI-R)
3. Has a non-verbal cognitive level of 70 or above (IQ cutoff is based on feasibility study data, and we make exceptions on a case-by-case basis to as low as 65)
4. Demonstrate difficulty processing and integrating sensory information as measured by the Sensory Profile (SP; 3 or more subscales or total test score in the definite difference range; or the Sensory Integration and Praxis Test -SIPT-; score of -1.0 on 3 or more subtests)
5. Guardians willing to attend 3 weekly sessions for the duration of the period and to refrain from initiation of any new behavioral, therapeutic or alternative treatments during the study period
6. If on psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study.

Exclusion Criteria

* Children who are receiving \> 12 hours/week of ongoing ASD-related services(excluding their educational programing), or who are receiving more than one hour per week of services that closely approximate the experimental intervention, will be excluded. Additionally, for safety reasons, children with significant medical co-morbidities (e.g., major heart problems, blindness, deafness, cerebral palsy, Fragile X or Down Syndrome, or tuberous sclerosis) will not be allowed to participate.

Minimum Eligible Age

6 Years

Maximum Eligible Age

114 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No