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RecruitingNCT07789704Updated Sep 10, 2026

Structured Sensory-Based Occupational Therapy in Children With Autism

An interventional study of Structured Sensory-Based Occupational Therapy and Individualized Home Activity Program in Autism Spectrum Disorder, sponsored by Emre DANSUK. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Emre DANSUK · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
3 Years to 9 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • Autism Spectrum Disorder
  • Occupational Therapy
  • Sensory-Based Intervention
  • Children
03

Who can participate

Ages eligible
3 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralStructured 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.

  • BehavioralIndividualized 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.

05

What researchers measure

Primary outcomes

  1. Change in Occupational Performance

    Occupational performance will be assessed using the performance score of the Canadian Occupational Performance Measure. Higher scores will indicate better perceived occupational performance.

    Time frame: Baseline and Week 12

  2. Change in Satisfaction with Occupational Performance

    Satisfaction with occupational performance will be assessed using the satisfaction score of the Canadian Occupational Performance Measure. Higher scores will indicate greater satisfaction.

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Change in Sensory Processing

    Sensory processing will be assessed using the Dunn Sensory Profile. Scale scores will be interpreted according to the instrument's standardized scoring system.

    Time frame: Baseline and Week 12

  2. Change in Gross Motor Development

    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.

    Time frame: Baseline and Week 12

  3. Change in Eating Behaviors

    Eating behaviors will be assessed using the Children's Eating Behaviour Questionnaire and its subscale scores.

    Time frame: Baseline and Week 12

06

Study locations

1 of 1 sites recruiting
  • Emre Dansuk
    Istanbul, Beykoz 34815, Turkey (Türkiye)
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07789704
Lead sponsor
Emre DANSUK
Responsible party
Emre DANSUK (Principal Investigator, Medipol University) — Sponsor-investigator
First posted
Aug 27, 2026
Start date
Aug 28, 2026
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Sep 10, 2026

Study contacts

Emre Dansuk, PhD
Contact
edansuk@medipol.edu.tr
05377790434
Burak Menek, PhD
Contact
Emre DANSUK, PhD
principal investigator · Medipol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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