NCT05718362

Brief Summary

Ayres Sensory Integration (ASI) Therapy is an individualized intervention designed to address specific underlying sensorimotor issues that may affect children's performance during daily routines and occupations. The intervention takes place in the context of play, emphasizes the active participation of the child, involves a collaborative relationship between the occupational therapist and the child, and focuses on participation-oriented outcomes that are collected at regular intervals throughout the intervention program. In general, its content is to improve the child's occupational performance. The program, which will be carried out in accordance with the Ayres Sensory Integration Fidelity Measure®, it is aimed to reduce the autism-specific symptoms of the child with autism and the dependence of the child on the caregiver in self-care activities. It is predicted that this whole process will increase the participation and his performance of the child with autism in his occupations related to his daily life. H0: Ayres Sensory Integration Therapy has no effect on the occupational performance of the child with autism spectrum disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

January 6, 2023

Last Update Submit

May 24, 2023

Conditions

Keywords

Ayres Sensory IntegrationOccupational Performance

Outcome Measures

Primary Outcomes (1)

  • Occupational Performance

    Occupational performance will be evaluated with Canadian Occupational Performance Measure (COPM). The measure is a goal-oriented, individualized, client-centered tool in which participants can set different goals in self-care, productivity, and leisure. * The measure is a semi-structured assessment applied to determine the daily activities that participants have difficulty with. * All activities said by the participants are scored between 1-10 points and the first five activities are selected. * These activities are also scored between 1-10 points according to performance and satisfaction. * Scores are compared by applying the same scale after the intervention.

    4 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Ayres Sensory Integration Therapy and Home Program

Behavioral: Ayres Sensory Integration TherapyBehavioral: Home Program

Control Group

ACTIVE COMPARATOR

Home Program

Behavioral: Home Program

Interventions

It is an intervention method whose effectiveness is questioned. It is a therapy program applied according to Ayres Sensory Integration Fidelity Measure.

Intervention Group
Home ProgramBEHAVIORAL

These are the activities created for the participants (both intervention and control groups) and to be done in the home environment.

Control GroupIntervention Group

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
  • Level 1 (requiring support) and Level 2 (requiring substantial support) are severity levels for Autism Spectrum Disorder
  • Age at first and second test between 3 years and 10 years

You may not qualify if:

  • Accompanying neurodevelopmental, psychiatric, neurological or physical diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, İ̇stanbul, 34762, Turkey (Türkiye)

Location

Related Publications (1)

  • Corakci Yazicioglu Z, Bumin G. Occupational Therapy Using Sensory Integration for Enhancing Occupational Performance in Children with Autism: A Randomized Controlled Trial. J Autism Dev Disord. 2025 Jul 25. doi: 10.1007/s10803-025-06970-1. Online ahead of print.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Zeynep Çorakcı

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 2 groups will be formed as study and control. A simple random distribution will be made when creating groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 6, 2023

First Posted

February 8, 2023

Study Start

January 6, 2023

Primary Completion

May 24, 2023

Study Completion

May 24, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations