Purpose

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

Eligibility

Eligible Ages
Between 6 Years and 102 Months
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Albert Einstein College of Medicine
Bronx, New York 10461
Contact:
Cat M Halpern, B.A.
718-862-1817
catherine.halpern@einstein.yu.edu

More Details

NCT ID
NCT02536365
Status
Recruiting
Sponsor
Albert Einstein College of Medicine

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.