Sensory Integration Therapy in Autism: Mechanisms and Effectiveness

• ClinicalTrials.gov Identifier: NCT02536365
• Recruitment Status: Recruiting
• First Posted: August 31, 2015
• Last Update Posted: August 5, 2022
• Sponsor: Albert Einstein College of Medicine
• Collaborators: Thomas Jefferson University; Queens College, The City University of New York; Children's Specialized Hospital
• Information provided by (Responsible Party): Sophie Molholm, Albert Einstein College of Medicine

Tracking Information

• First Submitted Date: August 27, 2015
• First Posted Date: August 31, 2015
• Last Update Posted Date: August 5, 2022
• Study Start Date: September 2015
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 28, 2015)

• The Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) Daily Living [ Time Frame: 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 ]
  The PEDI-CAT provides a valid and reliable assessment of the child's ability to perform daily living skills. The psychometric properties including validity and reliability are well documented and the PEDI-CAT showed good discriminant validity between groups of children with and without disabilities in all domains. Score estimates were found to be stable over time with strong test-retest reliability
• The Assessment of Motor and Process Skills (AMPS) [ Time Frame: Increase between week 0 and week 12 in functional adaptivity as assessed by AMPS, with follow up for stability of change at week 24 ]
  An observation-based, standardized performance assessment of daily living skills . It has been standardized on more than 150,000 persons, ages 2-100 years of age, internationally and cross-culturally.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 28, 2015)

Repetitive Behavior Scale-Revised (RBS-R) [ Time Frame: 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 ]

The RRB is a 43-item parent rating scale that measures the presence and severity of 6 types of repetitive behaviors: rituals/sameness (12 items), self-injurious behavior (8 items), stereotypic behavior (9 items), compulsive behavior (6 items), and restricted interests (3 items). The RBS-R yields an overall Total Score and six Subscale Scores, and has demonstrated reliability, stability, and validity in large autism samples.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
• Official Title: Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Autism

Intervention

• Behavioral: Sensory Integration Therapy
  Children in the SIT treatment group will receive a manualized SIT intervention that follows the principles of sensory integration.
• Behavioral: Applied Behavioral Analysis
  Children in the ABA treatment group will receive intervention that follows the principles of Applied Behavioral Analysis.

Study Arms

• Experimental: 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.
  Intervention: Behavioral: Sensory Integration Therapy
• Active Comparator: 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.
  Intervention: Behavioral: Applied Behavioral Analysis
• No Intervention: 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 3, 2022): 135
• Original Estimated Enrollment (submitted: August 28, 2015): 180
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 114 Months (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sophie Molholm, Ph.D.; 7188621823; sophie.molholm@einstein.yu.edu

Contact: Roseann Schaaf, Ph.D.,; 2155039609; Roseann.Schaaf@jefferson.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02536365
• Other Study ID Numbers: 2014-3795
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: We will not be sharing IPD

• Current Responsible Party: Sophie Molholm, Albert Einstein College of Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: Albert Einstein College of Medicine
• Original Study Sponsor: Same as current

Collaborators

• Thomas Jefferson University
• Queens College, The City University of New York
• Children's Specialized Hospital

Investigators

• Principal Investigator: Sophie Molholm, Ph.D.; Principal Investigator

• PRS Account: Albert Einstein College of Medicine
• Verification Date: August 2022