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Sensory Integration Therapy in Autism: Mechanisms and Effectiveness

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ClinicalTrials.gov Identifier: NCT02536365
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : November 7, 2019
Sponsor:
Collaborators:
Thomas Jefferson University
Queens College, The City University of New York
Information provided by (Responsible Party):
Sophie Molholm, Albert Einstein College of Medicine

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 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 2020
Estimated Study Completion Date : October 2021

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.



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.



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Ages Eligible for Study:   6 Years to 102 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between the ages of 6.0 and 8.5 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) 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
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536365


Contacts
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Contact: Sophie Molholm, Ph.D. 7188621823 sophie.molholm@einstein.yu.edu
Contact: Roseann Schaaf, Ph.D., 2155039609 Roseann.Schaaf@jefferson.edu

Locations
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United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Cat M Halpern, B.A.    718-862-1817    catherine.halpern@einstein.yu.edu   
Sponsors and Collaborators
Albert Einstein College of Medicine
Thomas Jefferson University
Queens College, The City University of New York
Investigators
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Principal Investigator: Sophie Molholm, Ph.D. Principal Investigator
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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    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not be sharing IPD
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders