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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Autism	Behavioral: Sensory Integration Therapy; Behavioral: Applied Behavioral Analysis	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
• Study Start Date: September 2015
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 114 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

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

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

Locations

United States, New Jersey

Children's Specialized Hospital; Recruiting

New Brunswick, New Jersey, United States, 08901

Contact: Joanne Hunt, MS jhunt@childrens-specialized.org

Contact: Rachel Dumont, PhD Rachel.Dumont@jefferson.edu

Sponsors and Collaborators

Albert Einstein College of Medicine

Thomas Jefferson University

Queens College, The City University of New York

Children's Specialized Hospital

Investigators

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

More Information

• Responsible Party: Sophie Molholm, Associate Professor, Albert Einstein College of Medicine
• ClinicalTrials.gov Identifier: NCT02536365
• Other Study ID Numbers: 2014-3795
• First Posted: August 31, 2015
• Last Update Posted: August 5, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

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

Additional relevant MeSH terms:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders