Autism Spectrum DisorderNCT05718362
Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder
A study testing Ayres Sensory Integration Therapy and Home Program in people with Autism Spectrum Disorder, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Ayres Sensory Integration (ASI) Therapy is an individualized intervention designed to address specific underlying sensorimotor issues that may affect children's performance during daily routines and occupations. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Ayres Sensory Integration Therapy and Home Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2023to 24 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
- Level 1 (requiring support) and Level 2 (requiring substantial support) are severity levels for Autism Spectrum Disorder
- Age at first and second test between 3 years and 10 years
Who cannot join
- Accompanying neurodevelopmental, psychiatric, neurological or physical diagnosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, İ̇stanbul, 34762
About this study
Official title: Investigation of the Effect of Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder: A Randomized Control
Ayres Sensory Integration (ASI) Therapy is an individualized intervention designed to address specific underlying sensorimotor issues that may affect children's performance during daily routines and occupations. The intervention takes place in the context of play, emphasizes the active participation of the child, involves a collaborative relationship between the occupational therapist and the child, and focuses on participation-oriented outcomes that are collected at regular intervals throughout the intervention program. In general, its content is to improve the child's occupational performance.
The program, which will be carried out in accordance with the Ayres Sensory Integration Fidelity Measure®, it is aimed to reduce the autism-specific symptoms of the child with autism and the dependence of the child on the caregiver in self-care activities. It is predicted that this whole process will increase the participation and his performance of the child with autism in his occupations related to his daily life.
H0: Ayres Sensory Integration Therapy has no effect on the occupational performance of the child with autism spectrum disorder.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Ayres Sensory Integration Therapy, Home Program
- Keywords
- Ayres Sensory Integration, Occupational Performance
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ayres Sensory Integration TherapyBehavioural
It is an intervention method whose effectiveness is questioned. It is a therapy program applied according to Ayres Sensory Integration Fidelity Measure.
Home ProgramBehavioural
These are the activities created for the participants (both intervention and control groups) and to be done in the home environment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Ayres Sensory Integration Therapy and Home Program Receives: Behavioral: Ayres Sensory Integration Therapy; Behavioral: Home Program |
| Control Group | Active comparator | Home Program Receives: Behavioral: Home Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupational Performance
Occupational performance will be evaluated with Canadian Occupational Performance Measure (COPM). The measure is a goal-oriented, individualized, client-centered tool in which participants can set different goals in self-care, productivity, and leisure.
- The measure is a semi-structured assessment applied to determine the daily activities that participants have difficulty with.
- All activities said by the participants are scored between 1-10 points and the first five activities are selected.
- These activities are also scored between 1-10 points according to performance and satisfaction.
- Scores are compared by applying the same scale after the intervention.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start6 Jan 2023
- Primary completion24 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups will be formed as study and control. A simple random distribution will be made when creating groups.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Çorakcı Yazıcıoğlu, Bezmialem Vakif University
- Investigators
- Zeynep Çorakcı, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718362
- Sponsor's protocol ID
- CORAKCİ-001
- Status last verified
- May 2023
- First submitted
- 6 Jan 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corakci Yazicioglu Z, Bumin G. Occupational Therapy Using Sensory Integration for Enhancing Occupational Performance in Children with Autism: A Randomized Controlled Trial. J Autism Dev Disord. 2025 Jul 25. doi: 10.1007/s10803-025-06970-1. Online ahead of print.
PubMed 40711707
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder: A Randomized Control
- ClinicalTrials.gov ID
- NCT05718362
- Acronym / sponsor ID
- CORAKCİ-001
- Conditions
- Autism Spectrum Disorder
- Keywords
- Ayres Sensory Integration, Occupational Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ayres Sensory Integration (ASI) Therapy is an individualized intervention designed to address specific underlying sensorimotor issues that may affect children's performance during daily routines and occupations. The intervention takes place in the context of play, emphasizes the active participation of the child, involves a collaborative relationship between the occupational therapist and the child, and focuses on participation-oriented outcomes that are collected at regular intervals throughout the intervention program. In general, its content is to improve the child's occupational performance.
The program, which will be carried out in accordance with the Ayres Sensory Integration Fidelity Measure®, it is aimed to reduce the autism-specific symptoms of the child with autism and the dependence of the child on the caregiver in self-care activities. It is predicted that this whole process will increase the participation and his performance of the child with autism in his occupations related to his daily life.
H0: Ayres Sensory Integration Therapy has no effect on the occupational performance of the child with autism spectrum disorder.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups will be formed as study and control. A simple random distribution will be made when creating groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Ayres Sensory Integration Therapy, Behavioral: Home ProgramAyres Sensory Integration Therapy and Home Program |
| Control Group | Active comparator | Behavioral: Home ProgramHome Program |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children diagnosed with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
- Level 1 (requiring support) and Level 2 (requiring substantial support) are severity levels for Autism Spectrum Disorder
- Age at first and second test between 3 years and 10 years
Key exclusion criteria (1 listed)
- Accompanying neurodevelopmental, psychiatric, neurological or physical diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ayres Sensory Integration TherapyIt is an intervention method whose effectiveness is questioned. It is a therapy program applied according to Ayres Sensory Integration Fidelity Measure. | Behavioural | Intervention Group |
| Home ProgramThese are the activities created for the participants (both intervention and control groups) and to be done in the home environment. | Behavioural | Control Group, Intervention Group |
Primary outcome
Occupational Performance
Time frame: 4 months
Occupational performance will be evaluated with Canadian Occupational Performance Measure (COPM). The measure is a goal-oriented, individualized, client-centered tool in which participants can set different goals in self-care, productivity, and leisure. * The measure is a semi-structured assessment applied to determine the daily activities that participants have difficulty with. * All activities said by the participants are scored between 1-10 points and the first five activities are selected. * These activities are also scored between 1-10 points according to performance and satisfaction. * Scores are compared by applying the same scale after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Derived from this study: PubMed 40711707Corakci Yazicioglu Z, Bumin G. Occupational Therapy Using Sensory Integration for Enhancing Occupational Performance in Children with Autism: A Randomized Controlled Trial. J Autism Dev Disord. 2025 Jul 25. doi: 10.1007/s10803-025-06970-1. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Çorakcı principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ayres Sensory Integration Therapy and Home Program in people with Autism Spectrum Disorder, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occupational Performance (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05718362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.