AutismNCT02536365
Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
A study testing Sensory Integration Therapy and Applied Behavioral Analysis in people with Autism, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years to 114 months
- Conditions the study is for
- Autism
- What is being tested?
- Sensory Integration Therapy and Applied Behavioral Analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 15 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years to 114 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Specialized Hospital
New Brunswick, New Jersey, 08901
About this study
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.
Read the 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.
- Conditions
- Autism
- Being tested
- Sensory Integration Therapy, Applied Behavioral Analysis
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Integration TherapyBehavioural
Children in the SIT treatment group will receive a manualized SIT intervention that follows the principles of sensory integration.
Applied Behavioral AnalysisBehavioural
Children in the ABA treatment group will receive intervention that follows the principles of Applied Behavioral Analysis.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Integration Therapy | Experimental | 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. Receives: Behavioral: Sensory Integration Therapy |
| Applied Behavioral Analysis | Active comparator | 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. Receives: Behavioral: Applied Behavioral Analysis |
| No Treatment | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) Daily Living
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
Measured: 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 Assessment of Motor and Process Skills (AMPS)
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.
Measured: Increase between week 0 and week 12 in functional adaptivity as assessed by AMPS, with follow up for stability of change at week 24
Secondary outcomes (1)
Repetitive Behavior Scale-Revised (RBS-R)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University, Queens College, The City University of New York, Children's Specialized Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sophie Molholm, Albert Einstein College of Medicine
- Investigators
- Sophie Molholm, Ph.D., Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536365
- Sponsor's protocol ID
- 2014-3795
- Other IDs
- R01HD082814
- Status last verified
- Aug 2023
- First submitted
- 27 Aug 2015
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We will not be sharing IPD
Publications
Schaaf RC, Ridgway EM, Jones EA, Dumont RL, Foxe J, Conly T, Sancimino C, Yi M, Mailloux Z, Hunt JM, Kirschner L, Leiby BE, Molholm S. A Comparative Trial of Occupational Therapy Using Ayres Sensory Integration and Applied Behavior Analysis Interventions for Autistic Children. Autism Res. 2025 Oct;18(10):2120-2134. doi: 10.1002/aur.70099. Epub 2025 Aug 15.
PubMed 40815044
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
- ClinicalTrials.gov ID
- NCT02536365
- Acronym / sponsor ID
- 2014-3795
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Thomas Jefferson University, Queens College, The City University of New York, Children's Specialized Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2015
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sensory Integration Therapy | Experimental | Behavioral: Sensory Integration TherapyChildren 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. |
| Applied Behavioral Analysis | Active comparator | Behavioral: Applied Behavioral AnalysisThis 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. |
| No Treatment | No intervention | –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. |
Who may qualify
- Ages
- 6 years to 114 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Integration TherapyChildren in the SIT treatment group will receive a manualized SIT intervention that follows the principles of sensory integration. | Behavioural | Sensory Integration Therapy |
| Applied Behavioral AnalysisChildren in the ABA treatment group will receive intervention that follows the principles of Applied Behavioral Analysis. | Behavioural | Applied Behavioral Analysis |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Derived from this study: PubMed 40815044Schaaf RC, Ridgway EM, Jones EA, Dumont RL, Foxe J, Conly T, Sancimino C, Yi M, Mailloux Z, Hunt JM, Kirschner L, Leiby BE, Molholm S. A Comparative Trial of Occupational Therapy Using Ayres Sensory Integration and Applied Behavior Analysis Interventions for Autistic Children. Autism Res. 2025 Oct;18(10):2120-2134. doi: 10.1002/aur.70099. Epub 2025 Aug 15.
- Individual participant dataSharing planned: No. We will not be sharing IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Molholm, Ph.D. principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Integration Therapy and Applied Behavioral Analysis in people with Autism, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02536365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.