Structured Sensory-Based Occupational Therapy in Children With Autism

August 27, 2026 updated by: Emre DANSUK

Effects of Structured Sensory-Based Occupational Therapy on Occupational Performance and Sensory-Motor Outcomes in Children With Autism Spectrum Disorder: A Controlled Clinical Study

This controlled clinical study will investigate the effects of a 12-week structured sensory-based occupational therapy intervention on occupational performance, sensory processing, gross motor development, and eating behaviors in children with autism spectrum disorder. Forty children aged 3-9 years will be assigned to either an intervention group receiving face-to-face occupational therapy twice weekly or a control group receiving an individualized home program.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This controlled clinical study will evaluate the effects of a structured sensory-based occupational therapy intervention on occupational performance, sensory processing, gross motor development, and eating behaviors in children with autism spectrum disorder.

A total of 40 children aged 3-9 years with Level 2 autism spectrum disorder will be assigned to a structured sensory-based occupational therapy group (n=20) or a control group (n=20). The intervention group will receive 40-minute, face-to-face occupational therapy sessions twice weekly for 12 weeks. The sessions will be structured according to each child's sensory and functional needs and will be progressively adapted based on the child's clinical development. The control group will receive individualized home recommendations, which will be monitored weekly using information and visual records provided by caregivers.

Assessments will be performed at baseline and after 12 weeks. Occupational performance and satisfaction will be evaluated using the Canadian Occupational Performance Measure, sensory processing using the Dunn Sensory Profile, gross motor development using the Test of Gross Motor Development-Third Edition, and eating behaviors using the Children's Eating Behaviour Questionnaire.

Study Type

Interventional

Enrollment (Estimated)

40

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 Contact

Study Contact Backup

  • Name: Burak Menek, PhD

Study Locations

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children aged 3-9 years
  • Diagnosis of autism spectrum disorder according to DSM-5 criteria
  • Level 2 autism spectrum disorder
  • Residence in Istanbul
  • Written informed consent provided by a parent or legal guardian

Exclusion Criteria:

  • Presence of an additional neurological, psychiatric, genetic, or developmental diagnosis
  • Regular medication use that may affect study outcomes
  • History of epilepsy or seizures
  • Inability to participate in the assessment or intervention procedures
  • Participation in another structured sensory-based occupational therapy program during the study period

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Structured Sensory-Based Occupational Therapy Group
Participants in this group will receive 40-minute, face-to-face structured sensory-based occupational therapy sessions twice weekly for 12 weeks. The intervention will be individualized according to each child's sensory and functional needs and will include tactile, proprioceptive, vestibular, visual-motor, gross motor, feeding-related, and occupational performance activities. Session content will be progressively adapted according to the child's development. Caregivers will also receive brief recommendations for home practice.
Behavioral: Structured Sensory-Based Occupational Therapy
The intervention will consist of individualized sensory-based occupational therapy activities addressing tactile, proprioceptive, vestibular, visual-motor, gross motor, feeding-related, and occupational performance needs. It will be delivered face-to-face for 40 minutes, twice weekly, over 12 weeks, and will be progressively adapted according to each child's clinical needs and development.
Active Comparator: Home Program Control Group
Participants in this group will receive individualized home-based activity recommendations using materials available in the home environment. The home program will be implemented for 12 weeks and will be monitored weekly for approximately 10 minutes using verbal information and visual records provided by caregivers. Participants will not receive face-to-face structured sensory-based occupational therapy during the study period.
Behavioral: Individualized Home Activity Program
Caregivers will implement individualized home-based sensory and functional activity recommendations using materials available in the home environment. The program will continue for 12 weeks and adherence will be monitored weekly through caregiver reports and visual records.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Occupational Performance
Time Frame: Baseline and Week 12
Occupational performance will be assessed using the performance score of the Canadian Occupational Performance Measure. Higher scores will indicate better perceived occupational performance.
Baseline and Week 12
Change in Satisfaction with Occupational Performance
Time Frame: Baseline and Week 12
Satisfaction with occupational performance will be assessed using the satisfaction score of the Canadian Occupational Performance Measure. Higher scores will indicate greater satisfaction.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sensory Processing
Time Frame: Baseline and Week 12
Sensory processing will be assessed using the Dunn Sensory Profile. Scale scores will be interpreted according to the instrument's standardized scoring system.
Baseline and Week 12
Change in Gross Motor Development
Time Frame: Baseline and Week 12
Gross motor development will be assessed using the Test of Gross Motor Development Third Edition, including locomotor and ball skills subscales. Higher scores will indicate better gross motor performance.
Baseline and Week 12
Change in Eating Behaviors
Time Frame: Baseline and Week 12
Eating behaviors will be assessed using the Children's Eating Behaviour Questionnaire and its subscale scores.
Baseline and Week 12

Collaborators and Investigators

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

Sponsor

Emre DANSUK

Investigators

  • Principal Investigator: Emre DANSUK, PhD, Medipol 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 (Estimated)

August 28, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

August 24, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-202.3.02-4787

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in the published article will be made available upon reasonable request to the corresponding author for scientifically sound research purposes. Data access will be subject to approval of the proposed use and completion of an appropriate data-sharing agreement, in accordance with institutional policies and applicable ethical requirements.

IPD Sharing Time Frame

Beginning immediately after publication and available for five years.

IPD Sharing Access Criteria

Data will be made available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the corresponding author and will require institutional approval and a signed data-sharing agreement. Data will be provided solely for the purposes specified in the approved proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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.

Subscribe