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
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.
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.
Exclusion Criteria:
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
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
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.
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.
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
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
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
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
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
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
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