Structured Sensory-Based Occupational Therapy in Children With Autism
ConditionAutism Spectrum Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-9
SponsorEmre DANSUK
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children aged 3-9 years
Diagnosis of autism spectrum disorder according to DSM-5 criteria
Level 2 autism spectrum disorder
Residence in Istanbul
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Structured Sensory-Based Occupational Therapy
BehavioralThe 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
BehavioralCaregivers 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Structured Sensory-Based Occupational Therapy GroupExperimental treatment 1 intervention
Group B: Home Program Control GroupActive comparator 1 intervention
Trial outcomes
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 122
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 12Secondary 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 122
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 123
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 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emre DANSUK
Lead sponsor
Medipol University
Sponsor institution
Source ClinicalTrials.gov