Autism Spectrum DisorderNCT07507630
Ayres Sensory Integration in Preschool Children With Autism Spectrum Disorder
A study testing Ayres Sensory Integration in people with Autism Spectrum Disorder, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effectiveness of occupational therapy using Ayres Sensory Integration® (ASI) in preschool children with autism spectrum disorder (ASD). The aim is to determine whether ASI, when added to usual individualized education program (IEP)-based education, improves adaptive functioning, goal… Read more about this study
- Who is it for?
- Ages 48 to 59 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Ayres Sensory Integration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Jan 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 48 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 48 and 59 months
- Diagnosis of autism spectrum disorder (ASD) according to DSM-5-TR, confirmed by a licensed child psychiatrist
- Classification of ASD based on the Turkish Version of the Gilliam Autism Rating Scale-2 (TV-GARS-2)
- Ongoing participation in an individualized education or therapy program during the study period
- Presence of sensory processing difficulties identified through standardized assessments (e.g., Sensory Profile or Sensory Integration and Praxis Test)
Who cannot join
- Previous or ongoing occupational therapy based on Ayres Sensory Integration®
- Receiving educational or therapeutic services exceeding the individualized program
- Presence of additional neurological or developmental conditions (e.g., cerebral palsy, Down syndrome)
- Known seizure disorders or other significant neurological conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Ayres Sensory Integration® in Autism Spectrum Disorder: Randomized Controlled Trial
This study evaluates the effectiveness of occupational therapy using Ayres Sensory Integration® (ASI) in preschool children with autism spectrum disorder (ASD). The aim is to determine whether ASI, when added to usual individualized education program (IEP)-based education, improves adaptive functioning, goal attainment, and sensory processing.
Children aged 48 to 59 months with a diagnosis of ASD were recruited from a pediatric rehabilitation center in Istanbul, Türkiye. Participants were randomly assigned to either an intervention group receiving ASI in addition to usual care or a control group receiving usual care only.
Read more
The intervention lasted 12 weeks. Outcomes were assessed before and after the intervention using standardized measures including the Vineland Adaptive Behavior Scales-Second Edition (VABS-II), Goal Attainment Scaling (GAS), and the Sensory Profile.
The study is designed as a single-blind randomized controlled trial, with outcome assessments conducted by individuals who were not involved in the intervention.
Read the detailed description
This single-blind randomized controlled trial was conducted to examine the effectiveness of occupational therapy using Ayres Sensory Integration® (ASI) in children with autism spectrum disorder (ASD). The study was carried out in a pediatric rehabilitation center in Istanbul, Türkiye between June 2021 and January 2023.
Participants were children aged 48 to 59 months who were diagnosed with ASD according to DSM-5-TR criteria and confirmed by a licensed child psychiatrist. Additional inclusion criteria included the presence of sensory processing difficulties identified through standardized assessments. Children with prior ASI intervention, significant neurological conditions, or additional developmental diagnoses were excluded.
After baseline assessment, participants were randomly assigned using a computer-based randomization system with concealed allocation. The intervention group received ASI delivered by a trained occupational therapist in addition to usual individualized education program (IEP)-based education. The ASI intervention consisted of approximately 36 hours over 12 weeks, typically delivered as three sessions per week, each lasting about 60 minutes. The control group continued to receive usual IEP-based educational services.
Outcome measures included adaptive functioning assessed by the Vineland Adaptive Behavior Scales-Second Edition (VABS-II), individualized goal performance measured by Goal Attainment Scaling (GAS), and sensory processing evaluated using the Sensory Profile. All outcomes were assessed at baseline and after the 12-week intervention period by evaluators who were blinded to group allocation.
The primary objective of the study was to determine whether ASI provides additional benefit beyond usual care in improving functional outcomes in children with ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Ayres Sensory Integration, Usual Care
- Keywords
- Autism Spectrum Disorder, Ayres Sensory Integration, Occupational Therapy, Randomized Controlled Trial
- 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 IntegrationBehavioural
Occupational therapy using Ayres Sensory Integration® delivered by a trained occupational therapist. The intervention was provided for approximately 12 weeks, typically three sessions per week, each lasting about 60 minutes.
Usual CareOther
Individualized education program (IEP)-based educational services provided at the rehabilitation center, including interventions targeting language, cognitive, motor, social-emotional, and adaptive skills.
| Study group | Role | What they receive |
|---|---|---|
| ASI + Usual Care | Experimental | Participants received Ayres Sensory Integration® in addition to usual care. Receives: Behavioral: Ayres Sensory Integration; Other: Usual Care |
| Usual Care | Active comparator | Participants received usual care only. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Goal Attainment Scaling (GAS) score
Goal Attainment Scaling (GAS) was used to evaluate individualized functional goal achievement. Scores were assessed at baseline and after the 12-week intervention period.
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Change in Vineland Adaptive Behavior Scales-Second Edition (VABS-II) scores
Vineland Adaptive Behavior Scales-Second Edition (VABS-II) was used to assess adaptive functioning. Scores were assessed at baseline and after the 12-week intervention period.
Measured: Baseline to 12 weeks
Change in Sensory Profile (SP) scores
Sensory Profile (SP) was used to assess sensory processing patterns. Scores were assessed at baseline and after the 12-week intervention period.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Jun 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to two parallel groups: ASI plus usual care and usual care only.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Furkan Cangi, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507630
- Sponsor's protocol ID
- ASI-ASD-RCT-2021
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request to the corresponding author, in accordance with institutional policies and ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ayres Sensory Integration® in Autism Spectrum Disorder: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07507630
- Acronym / sponsor ID
- ASI-ASD-RCT-2021
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Ayres Sensory Integration, Occupational Therapy, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 2 Apr 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.
This study evaluates the effectiveness of occupational therapy using Ayres Sensory Integration® (ASI) in preschool children with autism spectrum disorder (ASD). The aim is to determine whether ASI, when added to usual individualized education program (IEP)-based education, improves adaptive functioning, goal attainment, and sensory processing.
Children aged 48 to 59 months with a diagnosis of ASD were recruited from a pediatric rehabilitation center in Istanbul, Türkiye. Participants were randomly assigned to either an intervention group receiving ASI in addition to usual care or a control group receiving usual care only.
The intervention lasted 12 weeks. Outcomes were assessed before and after the intervention using standardized measures including the Vineland Adaptive Behavior Scales-Second Edition (VABS-II), Goal Attainment Scaling (GAS), and the Sensory Profile.
The study is designed as a single-blind randomized controlled trial, with outcome assessments conducted by individuals who were not involved in the intervention.
Detailed description
This single-blind randomized controlled trial was conducted to examine the effectiveness of occupational therapy using Ayres Sensory Integration® (ASI) in children with autism spectrum disorder (ASD). The study was carried out in a pediatric rehabilitation center in Istanbul, Türkiye between June 2021 and January 2023.
Participants were children aged 48 to 59 months who were diagnosed with ASD according to DSM-5-TR criteria and confirmed by a licensed child psychiatrist. Additional inclusion criteria included the presence of sensory processing difficulties identified through standardized assessments. Children with prior ASI intervention, significant neurological conditions, or additional developmental diagnoses were excluded.
After baseline assessment, participants were randomly assigned using a computer-based randomization system with concealed allocation. The intervention group received ASI delivered by a trained occupational therapist in addition to usual individualized education program (IEP)-based education. The ASI intervention consisted of approximately 36 hours over 12 weeks, typically delivered as three sessions per week, each lasting about 60 minutes. The control group continued to receive usual IEP-based educational services.
Outcome measures included adaptive functioning assessed by the Vineland Adaptive Behavior Scales-Second Edition (VABS-II), individualized goal performance measured by Goal Attainment Scaling (GAS), and sensory processing evaluated using the Sensory Profile. All outcomes were assessed at baseline and after the 12-week intervention period by evaluators who were blinded to group allocation.
The primary objective of the study was to determine whether ASI provides additional benefit beyond usual care in improving functional outcomes in children with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to two parallel groups: ASI plus usual care and usual care only.
| Arm | Type | Receives |
|---|---|---|
| ASI + Usual Care | Experimental | Behavioral: Ayres Sensory Integration, Other: Usual CareParticipants received Ayres Sensory Integration® in addition to usual care. |
| Usual Care | Active comparator | Other: Usual CareParticipants received usual care only. |
Who may qualify
- Ages
- 48 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age between 48 and 59 months
- Diagnosis of autism spectrum disorder (ASD) according to DSM-5-TR, confirmed by a licensed child psychiatrist
- Classification of ASD based on the Turkish Version of the Gilliam Autism Rating Scale-2 (TV-GARS-2)
- Ongoing participation in an individualized education or therapy program during the study period
- Presence of sensory processing difficulties identified through standardized assessments (e.g., Sensory Profile or Sensory Integration and Praxis Test)
Key exclusion criteria (4 listed)
- Previous or ongoing occupational therapy based on Ayres Sensory Integration®
- Receiving educational or therapeutic services exceeding the individualized program
- Presence of additional neurological or developmental conditions (e.g., cerebral palsy, Down syndrome)
- Known seizure disorders or other significant neurological conditions
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 IntegrationOccupational therapy using Ayres Sensory Integration® delivered by a trained occupational therapist. The intervention was provided for approximately 12 weeks, typically three sessions per week, each lasting about 60 minutes. | Behavioural | ASI + Usual Care |
| Usual CareIndividualized education program (IEP)-based educational services provided at the rehabilitation center, including interventions targeting language, cognitive, motor, social-emotional, and adaptive skills. | Other | ASI + Usual Care, Usual Care |
Primary outcome
Change in Goal Attainment Scaling (GAS) score
Time frame: Baseline to 12 weeks
Goal Attainment Scaling (GAS) was used to evaluate individualized functional goal achievement. Scores were assessed at baseline and after the 12-week intervention period.
2 secondary outcomes
Change in Vineland Adaptive Behavior Scales-Second Edition (VABS-II) scores
Time frame: Baseline to 12 weeks
Change in Sensory Profile (SP) scores
Time frame: Baseline to 12 weeks
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 2 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request to the corresponding author, in accordance with institutional policies and ethical regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Autism Spectrum Disorder, run by Medipol 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 5 inclusion and 4 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 2 Apr 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?
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?
Change in Goal Attainment Scaling (GAS) score (time frame: Baseline to 12 weeks). 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 2 Apr 2026.