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Ayres Sensory Integration in Preschool Children With Autism Spectrum Disorder

NCT07507630 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-04-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medipol University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
48 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-01-01
Completion
2023-01-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507630 on ClinicalTrials.gov