Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder

May 24, 2023 updated by: Zeynep Çorakcı Yazıcıoğlu, Bezmialem Vakif University

Investigation of the Effect of Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder: A Randomized Control

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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
    • İ̇stanbul
      • Istanbul, İ̇stanbul, Turkey, 34762
        • Bezmialem Vakıf University

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

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Accompanying neurodevelopmental, psychiatric, neurological or physical diagnosis

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Ayres Sensory Integration Therapy and Home Program
Behavioral: Ayres Sensory Integration Therapy
It is an intervention method whose effectiveness is questioned. It is a therapy program applied according to Ayres Sensory Integration Fidelity Measure.
Behavioral: Home Program
These are the activities created for the participants (both intervention and control groups) and to be done in the home environment.
Active Comparator: Control Group
Home Program
Behavioral: Home Program
These are the activities created for the participants (both intervention and control groups) and to be done in the home environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occupational Performance
Time Frame: 4 months

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

Collaborators and Investigators

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

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: Zeynep Çorakcı, Bezmialem Vakif 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)

January 6, 2023

Primary Completion (Actual)

May 24, 2023

Study Completion (Actual)

May 24, 2023

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORAKCİ-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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