Clinical trial NCT02536365: Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
Official title: Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
name: Queens College, The City University of New York
name: Children's Specialized Hospital
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-08-31
Enrollment: 135
Sex: ALL
Minimum age (years): 6
Maximum age (years): 114
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) Daily Living
timeFrame: Increase between week 0 and week 12 in functional adaptivity as assessed by PEDI-CAT, with follow up for stability of change at week 24
measure: The Assessment of Motor and Process Skills (AMPS)
timeFrame: Increase between week 0 and week 12 in functional adaptivity as assessed by AMPS, with follow up for stability of change at week 24
Secondary outcomes:
measure: Repetitive Behavior Scale-Revised (RBS-R)
timeFrame: Reduction between week 0 and week 12 in repetitive behavior scale score as assessed by RBS-R, with follow up for stability of change at week 24
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Children's Specialized Hospital
state: New Jersey
Study officials:
affiliation: Principal Investigator
name: Sophie Molholm, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: