NCT07507630

Ayres Sensory Integration in Preschool Children With Autism Spectrum Disorder

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Medipol University · Academic / Other
• Sex: All
• Age: 48 Months – 59 Months
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: Turkey (Türkiye)