Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07789704

Structured Sensory-Based Occupational Therapy in Children With Autism

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Sensory-Based Occupational Therapy

Behavioral

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.

Individualized Home Activity Program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Burak Menek, PhD

CONTACT

Emre Dansuk, PhD

CONTACT

[email protected]

05377790434

Sponsors and collaborators

Lead sponsor

Emre DANSUK

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.