Autism Spectrum DisorderNCT07740863
Occupational Therapy Intervention in Children Diagnosed With Early and Late Autism Spectrum Disorder
A study testing Occupational Therapy Intervention in people with Autism Spectrum Disorder, run by SEDANUR GÜRLEK.
Trial summary
Occupational Therapy Intervention in Children Diagnosed with Early and Late Autism Spectrum Disorder Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Occupational Therapy Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Mar 2027
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- being between 6 and 12 years of age
- having a formal diagnosis of ASD
- actively attending occupational therapy sessions.
Who cannot join
- Children with severe physical disabilities, significant visual or hearing impairments, or severe cognitive and communication limitations preventing participation in the assessment process were excluded.
About this study
Official title: Comparison of the Effects of Occupational Therapy Intervention on Sensory Processing and Executive Functions in Children Diagnosed With Early and Late Autism Spectrum Disorder
Occupational Therapy Intervention in Children Diagnosed with Early and Late Autism Spectrum Disorder
- Conditions
- Autism Spectrum Disorder
- Being tested
- Occupational Therapy Intervention
- 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.
Occupational Therapy InterventionOther
A pediatric occupational therapy intervention will be applied to improve children's performance and independence in daily living activities. The intervention will be structured according to the child's individual needs, functional capacity, developmental level, and difficulties in daily living activities. The intervention program will use activities aimed at supporting the child's performance in areas such as self-care, feeding, dressing, toileting, personal care, functional mobility, and participation in daily living routines. During the intervention process, the child's existing skills will be evaluated, and activities suitable for the child will be planned in line with activity analysis and a task-oriented approach. The intervention program will generally include the following components:
Assessment of the child's performance in daily living activities Setting individual goals Activity analysis and activity-based intervention Working on self-care and daily living skills
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Occupational Therapy Group Receives: Other: Occupational Therapy Intervention |
| Control Group | Experimental | Not described Receives: Other: Occupational Therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic form
age at diagnosis, weekly therapy frequency, total number of occupational therapy sessions, and sociodemographic data were recorded for all participants. All assessment forms were completed by caregivers during face-to-face interviews conducted before and after the intervention period.
Measured: 4 weeks
Sensory Processing Measure-Home (SPM-Home)
The Sensory Processing Measure - Home Form (SPM-H) is a caregiver-reported questionnaire designed to evaluate sensory processing and related functional behaviors in children aged 5 to 12 years (Parham \& Ecker, 2007). The form consists of 75 items and is completed by parents or primary caregivers in approximately 15-20 minutes. The SPM-H assesses several sensory domains, including vision, hearing, touch, body awareness, and balance and motion. These subscales contribute to a total sensory score. In addition, the scale includes social participation and planning/ideas subscales, which reflect higher-order integrative functions influenced by sensory processing. Items are rated on a four-point frequency scale ranging from "never" to "always," with higher scores indicating greater sensory processing difficulties. Raw scores are converted into standardized T-scores, which are interpreted as typical performance, some problems, or definite dysfunction. The Turkish adaptation of the scale demon
Measured: 4 weeks
Secondary outcomes (2)
Dunn Sensory Profile
The Dunn Sensory Profile is a caregiver-reported questionnaire developed to evaluate sensory processing patterns in children aged 3 to 10 years (Ermer \& Dunn, 1998). It consists of 125 items assessing multiple sensory domains, including auditory, visual, vestibular, tactile, multisensory, and oral sensory processing. The questionnaire is completed by caregivers who have regular contact with the child in daily life. Each item is rated on a 5-point frequency scale ranging from "always" to "never." Higher scores in each subdomain indicate greater difficulties in sensory processing. The Turkish adaptation of the scale was conducted by Kayıhan et al., demonstrating satisfactory psychometric properties, with Cronbach's alpha coefficients ranging between 0.63 and 0.97 across subdomains.
Measured: 4 weeks
Executive Function Occupational Routine Scale (EFORTS)
The scale is a parent-reported measure designed to assess children's executive functioning through everyday routines. It evaluates executive control within three domains: (a) morning and evening routines, (b) play and leisure activities, and (c) social routines. Parents rate 30 items using a 5-point Likert scale ranging from 1 (never) to 5 (always). Subscale and total scores are calculated by averaging item responses, with higher scores indicating better executive functioning in daily occupational performance. The scale also provides a cut-off score to identify the presence of executive dysfunction. EFORTS can be completed by parents in approximately 15 minutes in various settings. In the original validation study by Frisch and Rosenblum (2014), internal consistency was high, with subscale reliability coefficients ranging from 0.83 to 0.92 and an overall Cronbach's alpha of 0.947. Turkish validity and reliability were conducted by Akyurek et al. (2023).
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 posted3 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEDANUR GÜRLEK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SEDANUR GÜRLEK, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740863
- Sponsor's protocol ID
- AFSU
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Occupational Therapy Intervention on Sensory Processing and Executive Functions in Children Diagnosed With Early and Late Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07740863
- Acronym / sponsor ID
- AFSU
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SEDANUR GÜRLEKUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 3 Aug 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.
Occupational Therapy Intervention in Children Diagnosed with Early and Late Autism Spectrum Disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Occupational Therapy InterventionOccupational Therapy Group |
| Control Group | Experimental | Other: Occupational Therapy Intervention |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- being between 6 and 12 years of age
- having a formal diagnosis of ASD
- actively attending occupational therapy sessions.
Key exclusion criteria (1 listed)
- Children with severe physical disabilities, significant visual or hearing impairments, or severe cognitive and communication limitations preventing participation in the assessment process were excluded.
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 |
|---|---|---|
| Occupational Therapy InterventionA pediatric occupational therapy intervention will be applied to improve children's performance and independence in daily living activities. The intervention will be structured according to the child's individual needs, functional capacity, developmental level, and difficulties in daily living activities. The intervention program will use activities aimed at supporting the child's performance in areas such as self-care, feeding, dressing, toileting, personal care, functional mobility, and participation in daily living routines. During the intervention process, the child's existing skills will be evaluated, and activities suitable for the child will be planned in line with activity analysis and a task-oriented approach. The intervention program will generally include the following components: Assessment of the child's performance in daily living activities Setting individual goals Activity analysis and activity-based intervention Working on self-care and daily living skills | Other | Control Group, Study Group |
Primary outcome
Sociodemographic form
Time frame: 4 weeks
age at diagnosis, weekly therapy frequency, total number of occupational therapy sessions, and sociodemographic data were recorded for all participants. All assessment forms were completed by caregivers during face-to-face interviews conducted before and after the intervention period.
Sensory Processing Measure-Home (SPM-Home)
Time frame: 4 weeks
The Sensory Processing Measure - Home Form (SPM-H) is a caregiver-reported questionnaire designed to evaluate sensory processing and related functional behaviors in children aged 5 to 12 years (Parham \& Ecker, 2007). The form consists of 75 items and is completed by parents or primary caregivers in approximately 15-20 minutes. The SPM-H assesses several sensory domains, including vision, hearing, touch, body awareness, and balance and motion. These subscales contribute to a total sensory score. In addition, the scale includes social participation and planning/ideas subscales, which reflect higher-order integrative functions influenced by sensory processing. Items are rated on a four-point frequency scale ranging from "never" to "always," with higher scores indicating greater sensory processing difficulties. Raw scores are converted into standardized T-scores, which are interpreted as typical performance, some problems, or definite dysfunction. The Turkish adaptation of the scale demon
2 secondary outcomes
Dunn Sensory Profile
Time frame: 4 weeks
Executive Function Occupational Routine Scale (EFORTS)
Time frame: 4 weeks
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 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy Intervention in people with Autism Spectrum Disorder, run by SEDANUR GÜRLEK.
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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Sociodemographic form (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 3 Aug 2026.