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
|Condition or disease||Intervention/treatment||Phase|
|Autism||Behavioral: Sensory Integration Therapy Behavioral: Applied Behavioral Analysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 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 2020|
|Estimated Study Completion Date :||October 2021|
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.
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 York|
|Albert Einstein College of Medicine||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Cat M Halpern, B.A. 718-862-1817 firstname.lastname@example.org|
|Principal Investigator:||Sophie Molholm, Ph.D.||Principal Investigator|