Sensory Processing DisorderNCT07656961
Ayres Sensory Integration Test Evaluation Results and Neurodevelopmentally Focused Counseling in Children With Neurodevelopmental Problems
An observational study of Sensory Processing Disorder and Neurodevelomental Disorders, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the long-term effects of ASI-based and hybrid neurodevelopmental counseling services on the variables of the Ayres Sensory Integration Assessment Test in children with neurodevelopmental disorders. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensory Processing Disorder, Neurodevelomental Disorders
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jun 2026to 16 Jan 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will consist of children aged 3 to 12 years with diagnosed or suspected neurodevelopmental problems who apply to the YUGEM Sensory Perception Motor Unit at Yeditepe University. Children referred for neurodevelopmental follow-up and considered suitable for the Evaluation in Ayres Sensory Integration assessment will be included in the study.
Who may be able to join
- Aged 3-12
- Sensory sensitivity (excessive or under-reaction to tactile, movement, auditory, or visual stimuli)
- Have been referred by a pediatrician for neurodevelopmental monitoring
- Have coordination difficulties
- Difficulty organizing gross and/or fine motor movements
- Activity level significantly above or below the norm for their age
- Delays in academic achievement
- Difficulties with daily living skills such as dressing and personal hygiene
Who cannot join
- Being under 3 years of age or over 12 years of age
- Having no conditions that fall outside normal developmental parameters
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of the study is to investigate the long-term effects of ASI-based and hybrid neurodevelopmental counseling services on the variables of the Ayres Sensory Integration Assessment Test in children with neurodevelopmental disorders.
Read the detailed description
After application to the YUGEM Sensory Perception Motor Unit, the child and family will undergo a preliminary assessment. Following the necessary interviews and psychiatric consultation, specialists will decide whether the child is suitable for the Evaluation in Ayres Sensory Integration (EASI).
Children who are considered suitable for the EASI assessment will be evaluated through a multidisciplinary approach. The data obtained from the assessment will be analyzed using computer-based statistical software, and the results will be reviewed by the specialists. Based on these results, the frequency, duration, and delivery method of sensory integration therapy will be determined according to the needs of the child and family.
Neurodevelopmentally focused therapy counseling based on Ayres Sensory Integration principles will be planned either face-to-face or remotely, as appropriate for the child and family. After this decision, a meeting will be held with the family to plan the child's therapy process. There will be a 6-month therapy-counseling process.
- Keywords
- Neurodevelopmental Disorders, Sensory Integration, EASI
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children With Neurodevelopmental Disorders | Children aged 3 to 12 years with neurodevelopmental disorders who applied to the YUGEM Sensory Perception Motor Unit and are considered suitable for the Evaluation in Ayres Sensory Integration assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Evaluation of Ayres Sensory Integration (EASI)
The Evaluation of Ayres Sensory Intergation test measures sensory perception, postural/ocular/bilateral motor integration, praxis, and sensory reactivity in a way that minimizes the effects of culture, language comprehension, and prior experience. The EASI tests are designed for children aged 3-12 and will be administered by appropriately trained professionals.
Measured: 4 Weeks
Pediatric Sensory Profile
This is a measure consisting of three main sections used in children. These are; sensory processing, modulation and behavioral and emotional responses. The subgroups of each main section (14 sections in total, 125 questions) are tested. This scale is administered by the caregiver.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start18 Jun 2026 (estimated)
- Primary completion16 Jul 2026 (estimated)
- Study completion16 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Processing DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Develi, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656961
- Sponsor's protocol ID
- 125
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It's not decided.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ayres Sensory Integration Test Evaluation Results and Neurodevelopmentally Focused Counseling in Children With Neurodevelopmental Problems
- ClinicalTrials.gov ID
- NCT07656961
- Acronym / sponsor ID
- 125
- Keywords
- Neurodevelopmental Disorders, Sensory Integration, EASI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 18 Jun 2026 (estimated)
- Primary completion
- 16 Jul 2026 (estimated)
- Study completion
- 16 Jan 2027 (estimated)
- First posted
- 18 Jun 2026 (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.
The aim of the study is to investigate the long-term effects of ASI-based and hybrid neurodevelopmental counseling services on the variables of the Ayres Sensory Integration Assessment Test in children with neurodevelopmental disorders.
Detailed description
After application to the YUGEM Sensory Perception Motor Unit, the child and family will undergo a preliminary assessment. Following the necessary interviews and psychiatric consultation, specialists will decide whether the child is suitable for the Evaluation in Ayres Sensory Integration (EASI).
Children who are considered suitable for the EASI assessment will be evaluated through a multidisciplinary approach. The data obtained from the assessment will be analyzed using computer-based statistical software, and the results will be reviewed by the specialists. Based on these results, the frequency, duration, and delivery method of sensory integration therapy will be determined according to the needs of the child and family.
Neurodevelopmentally focused therapy counseling based on Ayres Sensory Integration principles will be planned either face-to-face or remotely, as appropriate for the child and family. After this decision, a meeting will be held with the family to plan the child's therapy process. There will be a 6-month therapy-counseling process.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children With Neurodevelopmental Disorders | – | –Children aged 3 to 12 years with neurodevelopmental disorders who applied to the YUGEM Sensory Perception Motor Unit and are considered suitable for the Evaluation in Ayres Sensory Integration assessment. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of children aged 3 to 12 years with diagnosed or suspected neurodevelopmental problems who apply to the YUGEM Sensory Perception Motor Unit at Yeditepe University. Children referred for neurodevelopmental follow-up and considered suitable for the Evaluation in Ayres Sensory Integration assessment will be included in the study.
Key inclusion criteria (8 listed)
- Aged 3-12
- Sensory sensitivity (excessive or under-reaction to tactile, movement, auditory, or visual stimuli)
- Have been referred by a pediatrician for neurodevelopmental monitoring
- Have coordination difficulties
- Difficulty organizing gross and/or fine motor movements
Key exclusion criteria (2 listed)
- Being under 3 years of age or over 12 years of age
- Having no conditions that fall outside normal developmental parameters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Evaluation of Ayres Sensory Integration (EASI)
Time frame: 4 Weeks
The Evaluation of Ayres Sensory Intergation test measures sensory perception, postural/ocular/bilateral motor integration, praxis, and sensory reactivity in a way that minimizes the effects of culture, language comprehension, and prior experience. The EASI tests are designed for children aged 3-12 and will be administered by appropriately trained professionals.
Pediatric Sensory Profile
Time frame: 4 weeks
This is a measure consisting of three main sections used in children. These are; sensory processing, modulation and behavioral and emotional responses. The subgroups of each main section (14 sections in total, 125 questions) are tested. This scale is administered by the caregiver.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided. It's not decided.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensory Processing Disorder and Neurodevelomental Disorders, run by Yeditepe 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 8 inclusion and 2 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: opening soon, as of the sponsor's last update on 18 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Develi, PhD (+90 555 593 62 93, elifstn@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Evaluation of Ayres Sensory Integration (EASI) (time frame: 4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2026.