ClinicalTrials.gg
RecruitingNCT07789704Updated Oct 20, 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 2026-10-20.

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

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 20, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
3 Years to 9 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 56 studies in Autism Spectrum Disorder with a site in Turkey — 11 open to participants now, 12 under way, none of them phase 3. Autism Spectrum Disorder · Turkey.

Planned enrollment
18th of 46
40 · median 35
Started
2026
with 6 others
No phase
46 of 56
8 open now
Primary completion
2027-01
later than 9 of 11 live
Registered
54th of 56
by date

Among the 56 studies in Autism Spectrum Disorder with a site in Turkey, this one is the 18th largest by planned enrollment of the 46 interventional ones, is one of 7 that started in 2026, is one of 46 with no phase, reaches primary completion later than 9 of the 11 other live ones, and was the 54th registered.

By phase

56 studies; the count open now beside each. This study's row is marked.

No phasethis study46 · 8 open
Observational10 · 3 open

By the year they started

First in 2017; this study’s year is marked. 7 started in 2026.

Size and results

Median enrollment 35 across the 46 interventional studies, 74 across the 10 observational. Of the 44 that completed or were terminated, 0 (0%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 56 studies in Autism Spectrum Disorder with a site in Turkey, or all of them as a file.
02

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.

03

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • Autism Spectrum Disorder
  • Occupational Therapy
  • Sensory-Based Intervention
  • Children
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children aged 3-9 years
  • Diagnosis of autism spectrum disorder according to criteria
  • Level 2 autism spectrum disorder
  • Residence in Istanbul
  • Written 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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.

06

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

07

Study locations

1 of 1 sites recruiting
  • Emre Dansuk
    Istanbul, Beykoz 34815, Turkey (Türkiye)
    Recruiting
08

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

Time frame: Beginning immediately after publication and available for five years.

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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jan 2027, 4 months after the start.

Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 4 months is below that.

Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 20, 2026: primary completion Nov 2026 → Jan 2027 and completion Nov 2026 → Jan 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2026
First posted
Aug 27, 2026
StartActual
Aug 28, 2026
Primary completionEst.
Jan 1, 2027was Nov 2026
CompletionEst.
Jan 1, 2027was Nov 2026
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Nov 1, 2026→Jan 1, 2027
Oct 20, 2026
Study completion
Nov 1, 2026→Jan 1, 2027
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Primary completion Nov 1, 2026→Jan 1, 2027
    Study completion Nov 1, 2026→Jan 1, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

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
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Oct 20, 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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