Ayres Sensory Integration in Preschool Children With Autism Spectrum Disorder

March 27, 2026 updated by: Abdullah Furkan Cangi, Medipol University

Effectiveness of Ayres Sensory Integration® in Autism Spectrum Disorder: Randomized Controlled Trial

This study evaluates the effectiveness of occupational therapy using Ayres Sensory Integration® (ASI) in preschool children with autism spectrum disorder (ASD). The aim is to determine whether ASI, when added to usual individualized education program (IEP)-based education, improves adaptive functioning, goal attainment, and sensory processing.

Children aged 48 to 59 months with a diagnosis of ASD were recruited from a pediatric rehabilitation center in Istanbul, Türkiye. Participants were randomly assigned to either an intervention group receiving ASI in addition to usual care or a control group receiving usual care only.

The intervention lasted 12 weeks. Outcomes were assessed before and after the intervention using standardized measures including the Vineland Adaptive Behavior Scales-Second Edition (VABS-II), Goal Attainment Scaling (GAS), and the Sensory Profile.

The study is designed as a single-blind randomized controlled trial, with outcome assessments conducted by individuals who were not involved in the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This single-blind randomized controlled trial was conducted to examine the effectiveness of occupational therapy using Ayres Sensory Integration® (ASI) in children with autism spectrum disorder (ASD). The study was carried out in a pediatric rehabilitation center in Istanbul, Türkiye between June 2021 and January 2023.

Participants were children aged 48 to 59 months who were diagnosed with ASD according to DSM-5-TR criteria and confirmed by a licensed child psychiatrist. Additional inclusion criteria included the presence of sensory processing difficulties identified through standardized assessments. Children with prior ASI intervention, significant neurological conditions, or additional developmental diagnoses were excluded.

After baseline assessment, participants were randomly assigned using a computer-based randomization system with concealed allocation. The intervention group received ASI delivered by a trained occupational therapist in addition to usual individualized education program (IEP)-based education. The ASI intervention consisted of approximately 36 hours over 12 weeks, typically delivered as three sessions per week, each lasting about 60 minutes. The control group continued to receive usual IEP-based educational services.

Outcome measures included adaptive functioning assessed by the Vineland Adaptive Behavior Scales-Second Edition (VABS-II), individualized goal performance measured by Goal Attainment Scaling (GAS), and sensory processing evaluated using the Sensory Profile. All outcomes were assessed at baseline and after the 12-week intervention period by evaluators who were blinded to group allocation.

The primary objective of the study was to determine whether ASI provides additional benefit beyond usual care in improving functional outcomes in children with ASD.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Uskudar
      • Istanbul, Uskudar, Turkey (Türkiye)
        • Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 48 and 59 months
  • Diagnosis of autism spectrum disorder (ASD) according to DSM-5-TR, confirmed by a licensed child psychiatrist
  • Classification of ASD based on the Turkish Version of the Gilliam Autism Rating Scale-2 (TV-GARS-2)
  • Ongoing participation in an individualized education or therapy program during the study period
  • Presence of sensory processing difficulties identified through standardized assessments (e.g., Sensory Profile or Sensory Integration and Praxis Test)

Exclusion Criteria:

  • Previous or ongoing occupational therapy based on Ayres Sensory Integration®
  • Receiving educational or therapeutic services exceeding the individualized program
  • Presence of additional neurological or developmental conditions (e.g., cerebral palsy, Down syndrome)
  • Known seizure disorders or other significant neurological conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASI + Usual Care
Participants received Ayres Sensory Integration® in addition to usual care.
Behavioral: Ayres Sensory Integration
Occupational therapy using Ayres Sensory Integration® delivered by a trained occupational therapist. The intervention was provided for approximately 12 weeks, typically three sessions per week, each lasting about 60 minutes.
Other: Usual Care
Individualized education program (IEP)-based educational services provided at the rehabilitation center, including interventions targeting language, cognitive, motor, social-emotional, and adaptive skills.
Active Comparator: Usual Care
Participants received usual care only.
Other: Usual Care
Individualized education program (IEP)-based educational services provided at the rehabilitation center, including interventions targeting language, cognitive, motor, social-emotional, and adaptive skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Goal Attainment Scaling (GAS) score
Time Frame: Baseline to 12 weeks
Goal Attainment Scaling (GAS) was used to evaluate individualized functional goal achievement. Scores were assessed at baseline and after the 12-week intervention period.
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vineland Adaptive Behavior Scales-Second Edition (VABS-II) scores
Time Frame: Baseline to 12 weeks
Vineland Adaptive Behavior Scales-Second Edition (VABS-II) was used to assess adaptive functioning. Scores were assessed at baseline and after the 12-week intervention period.
Baseline to 12 weeks
Change in Sensory Profile (SP) scores
Time Frame: Baseline to 12 weeks
Sensory Profile (SP) was used to assess sensory processing patterns. Scores were assessed at baseline and after the 12-week intervention period.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASI-ASD-RCT-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request to the corresponding author, in accordance with institutional policies and ethical regulations.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication and will remain available for 5 years.

IPD Sharing Access Criteria

Data will be available to researchers who provide a methodologically sound proposal and receive approval from the study investigators, in accordance with institutional and ethical guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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