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 : August 5, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Autism||Behavioral: Sensory Integration Therapy Behavioral: Applied Behavioral Analysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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.
- 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.
- 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 114 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Between the ages of 6.0 and 9.5 at the time of enrollment
- 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)
- 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)
- 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)
- 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
- If on psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study.
- 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.
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
|Contact: Sophie Molholm, Ph.D.||email@example.com|
|Contact: Roseann Schaaf, Ph.D.,||2155039609||Roseann.Schaaf@jefferson.edu|
|United States, New Jersey|
|Children's Specialized Hospital||Recruiting|
|New Brunswick, New Jersey, United States, 08901|
|Contact: Joanne Hunt, MS firstname.lastname@example.org|
|Contact: Rachel Dumont, PhD Rachel.Dumont@jefferson.edu|
|Principal Investigator:||Sophie Molholm, Ph.D.||Principal Investigator|
|Responsible Party:||Sophie Molholm, Associate Professor, Albert Einstein College of Medicine|
|Other Study ID Numbers:||
|First Posted:||August 31, 2015 Key Record Dates|
|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|
Autism Spectrum Disorder
Child Development Disorders, Pervasive