Ayres Sensory Integration in Preschool Children With Autism Spectrum Disorder

NCT07507630 | Completed

• 1 other identifier: ASI-ASD-RCT-2021
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Ayres Sensory Integration; Occupational Therapy; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in Goal Attainment Scaling (GAS) score

  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 Outcomes (2)

• Change in Vineland Adaptive Behavior Scales-Second Edition (VABS-II) scores

  Baseline to 12 weeks

• Change in Sensory Profile (SP) scores

  Baseline to 12 weeks

Study Arms (2)

ASI + Usual Care

EXPERIMENTAL

Participants received Ayres Sensory Integration® in addition to usual care.

Behavioral: Ayres Sensory Integration; Other: Usual Care

Usual Care

ACTIVE COMPARATOR

Participants received usual care only.

Other: Usual Care

Interventions

Ayres Sensory Integration BEHAVIORAL

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.

ASI + Usual Care

Usual Care OTHER

Individualized education program (IEP)-based educational services provided at the rehabilitation center, including interventions targeting language, cognitive, motor, social-emotional, and adaptive skills.

ASI + Usual Care; Usual Care

Eligibility Criteria

• Age: 48 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Rehabilitation Center

Istanbul, Uskudar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist

Model Details: Participants were randomly assigned to two parallel groups: ASI plus usual care and usual care only.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: June 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available beginning 6 months after publication and will remain available for 5 years.
• 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.

Locations

TU (1)