Autism Spectrum DisorderNCT07717853
Preliminary Effects of the CO-OP Approach in Children With Autism Spectrum Disorder
A study testing Cognitive Orientation to Daily Occupational Performance Approach in people with Autism Spectrum Disorder, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
Autism spectrum disorder may affect children's participation in daily occupations through difficulties related to motor planning, problem-solving, attention, behavioral regulation, and sensory processing. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Cognitive Orientation to Daily Occupational Performance Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2026to 30 Sep 2026
- 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having a clinical diagnosis of autism spectrum disorder
- Being of primary school age
- Having communication and cooperation skills sufficient to participate in the - Cognitive Orientation to Daily Occupational Performance intervention
- Having at least one daily occupational performance goal identified by the child and/or family
- Being able to attend the assessment and intervention sessions regularly
- Provision of written informed consent by a parent or legal guardian
Who cannot join
- Having a severe neurological, orthopedic, or psychiatric condition that may substantially affect the assessment or intervention process
- Having severe behavioral difficulties that prevent safe and consistent participation in the intervention sessions
- Having participated in an intensive, structured cognitive strategy-based intervention program within the previous 6 months
- Withdrawal of the child or parent/legal guardian from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ceren Davutoğlu contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atlas University
Istanbul, Istanbul, 34762
Zeynep Çorakcı Yazıcıoğlu, 05376699979, zcorakci@gmail.com
Ceren Davutoğlu
About this study
Official title: Preliminary Effects of the Cognitive Orientation to Daily Occupational Performance Approach on Occupational Performance in Children With Autism Spectrum Disorder: A Pilot Study
Autism spectrum disorder may affect children's participation in daily occupations through difficulties related to motor planning, problem-solving, attention, behavioral regulation, and sensory processing. The Cognitive Orientation to Daily Occupational Performance approach is a goal-oriented intervention that supports children in identifying and using cognitive strategies to improve the performance of personally meaningful activities.
This pilot study aims to examine the preliminary effects of a 10-session Cognitive Orientation to Daily Occupational Performance intervention on occupational performance, satisfaction with performance, observed performance quality, and individualized goal attainment in primary school-aged children with autism spectrum disorder. Possible changes in autism-related behavioral characteristics and sensory processing patterns will also be examined.
Read the detailed description
Children with autism spectrum disorder may experience difficulties in performing and participating in daily occupations due to differences in executive functioning, motor planning, attention, behavioral regulation, and sensory processing.
The Cognitive Orientation to Daily Occupational Performance approach is a client-centered, performance-based intervention that uses collaborative goal setting, guided discovery, dynamic performance analysis, domain-specific strategies, and the global problem-solving strategy "Goal-Plan-Do-Check." The approach aims not only to improve performance in selected activities but also to support strategy use, generalization, and transfer of learning to daily life.
In this single-group pilot study, eligible children with autism spectrum disorder will receive 10 individual intervention sessions based on the Cognitive Orientation to Daily Occupational Performance approach. Before the intervention, individualized occupational performance goals will be identified with the child and family. Baseline assessments will evaluate perceived occupational performance and satisfaction, observed performance quality, individualized goal attainment, autism-related behaviors, and sensory processing characteristics.
Following completion of the 10-session intervention program, the same outcome measures will be administered again. Pre-intervention and post-intervention scores will be compared to estimate the preliminary effects and clinical relevance of the intervention. The findings are expected to provide feasibility and preliminary effect-size data for future studies with larger samples and controlled designs.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Cognitive Orientation to Daily Occupational Performance Approach
- Keywords
- Autism Spectrum Disorder, Cognitive Orientation to Daily Occupational Performance, Occupational Therapy
- 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.
Cognitive Orientation to Daily Occupational Performance ApproachBehavioural
Also called CO-OP Approach
The Cognitive Orientation to Daily Occupational Performance approach is an individualized, goal-oriented intervention designed to improve the performance of meaningful daily activities through cognitive strategy use and guided discovery. Participants will complete 10 individual sessions, each lasting approximately 45 to 60 minutes. The intervention will target individualized occupational performance goals identified with the child and family. The global strategy "Goal-Plan-Do-Check" and task-specific strategies will be used to facilitate skill acquisition, problem-solving, generalization, and transfer.
| Study group | Role | What they receive |
|---|---|---|
| CO-OP Intervention | Experimental | Participants will receive 10 individual sessions based on the Cognitive Orientation to Daily Occupational Performance approach. The intervention will focus on child- and family-identified daily occupational performance goals. Sessions will involve collaborative goal setting, dynamic performance analysis, guided discovery, cognitive strategy use, and the global strategy "Goal-Plan-Do-Check." Strategies will be practiced in relation to the selected activities, with emphasis on generalization and transfer to daily life. Receives: Behavioral: Cognitive Orientation to Daily Occupational Performance Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
Satisfaction with performance for each prioritized activity is rated on a scale from 1 to 10, with higher scores indicating greater satisfaction. The mean satisfaction score will be calculated. Change will be determined by comparing baseline and post-intervention scores.
Measured: Baseline and immediately after completion of the 10-session intervention
Performance Quality Rating Scale
The Performance Quality Rating Scale is an observational measure used to rate the quality of performance of individualized activities. Performance is rated from 1 to 10, with higher scores indicating better performance quality. Each participant's selected occupational goals will be rated at baseline and after the intervention.
Measured: Baseline and immediately after completion of the 10-session intervention
Secondary outcomes (2)
Goal Attainment Scale
Goal Attainment Scale is an individualized method for evaluating the extent to which intervention goals are achieved. Performance for each goal is rated on a five-point scale ranging from -2 to +2. A score of 0 represents the expected level of goal attainment, negative scores represent performance below the expected level, and positive scores represent performance above the expected level.
Measured: Baseline and immediately after completion of the 10-session intervention
Childhood Autism Rating Scale
The Childhood Autism Rating Scale is a caregiver-reported measure of autism-related behavioral characteristics across sensory behavior, relating, body and object use, language, and social and self-help domains. Items are scored using weighted values, and higher total scores indicate a greater number or severity of autism-related behavioral characteristics.
Measured: Baseline and immediately after completion of the 10-session intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start10 Jul 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Yazicioglu, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717853
- Sponsor's protocol ID
- Yazicioglu_3
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Effects of the Cognitive Orientation to Daily Occupational Performance Approach on Occupational Performance in Children With Autism Spectrum Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT07717853
- Acronym / sponsor ID
- Yazicioglu_3
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Cognitive Orientation to Daily Occupational Performance, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Jul 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.
Autism spectrum disorder may affect children's participation in daily occupations through difficulties related to motor planning, problem-solving, attention, behavioral regulation, and sensory processing. The Cognitive Orientation to Daily Occupational Performance approach is a goal-oriented intervention that supports children in identifying and using cognitive strategies to improve the performance of personally meaningful activities.
This pilot study aims to examine the preliminary effects of a 10-session Cognitive Orientation to Daily Occupational Performance intervention on occupational performance, satisfaction with performance, observed performance quality, and individualized goal attainment in primary school-aged children with autism spectrum disorder. Possible changes in autism-related behavioral characteristics and sensory processing patterns will also be examined.
Detailed description
Children with autism spectrum disorder may experience difficulties in performing and participating in daily occupations due to differences in executive functioning, motor planning, attention, behavioral regulation, and sensory processing.
The Cognitive Orientation to Daily Occupational Performance approach is a client-centered, performance-based intervention that uses collaborative goal setting, guided discovery, dynamic performance analysis, domain-specific strategies, and the global problem-solving strategy "Goal-Plan-Do-Check." The approach aims not only to improve performance in selected activities but also to support strategy use, generalization, and transfer of learning to daily life.
In this single-group pilot study, eligible children with autism spectrum disorder will receive 10 individual intervention sessions based on the Cognitive Orientation to Daily Occupational Performance approach. Before the intervention, individualized occupational performance goals will be identified with the child and family. Baseline assessments will evaluate perceived occupational performance and satisfaction, observed performance quality, individualized goal attainment, autism-related behaviors, and sensory processing characteristics.
Following completion of the 10-session intervention program, the same outcome measures will be administered again. Pre-intervention and post-intervention scores will be compared to estimate the preliminary effects and clinical relevance of the intervention. The findings are expected to provide feasibility and preliminary effect-size data for future studies with larger samples and controlled designs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CO-OP Intervention | Experimental | Behavioral: Cognitive Orientation to Daily Occupational Performance ApproachParticipants will receive 10 individual sessions based on the Cognitive Orientation to Daily Occupational Performance approach. The intervention will focus on child- and family-identified daily occupational performance goals. Sessions will involve collaborative goal setting, dynamic performance analysis, guided discovery, cognitive strategy use, and the global strategy "Goal-Plan-Do-Check." Strategies will be practiced in relation to the selected activities, with emphasis on generalization and transfer to daily life. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Having a clinical diagnosis of autism spectrum disorder
- Being of primary school age
- Having communication and cooperation skills sufficient to participate in the - Cognitive Orientation to Daily Occupational Performance intervention
- Having at least one daily occupational performance goal identified by the child and/or family
- Being able to attend the assessment and intervention sessions regularly
Key exclusion criteria (4 listed)
- Having a severe neurological, orthopedic, or psychiatric condition that may substantially affect the assessment or intervention process
- Having severe behavioral difficulties that prevent safe and consistent participation in the intervention sessions
- Having participated in an intensive, structured cognitive strategy-based intervention program within the previous 6 months
- Withdrawal of the child or parent/legal guardian from the study
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 |
|---|---|---|
| Cognitive Orientation to Daily Occupational Performance ApproachAlso: CO-OP ApproachThe Cognitive Orientation to Daily Occupational Performance approach is an individualized, goal-oriented intervention designed to improve the performance of meaningful daily activities through cognitive strategy use and guided discovery. Participants will complete 10 individual sessions, each lasting approximately 45 to 60 minutes. The intervention will target individualized occupational performance goals identified with the child and family. The global strategy "Goal-Plan-Do-Check" and task-specific strategies will be used to facilitate skill acquisition, problem-solving, generalization, and transfer. | Behavioural | CO-OP Intervention |
Primary outcome
Canadian Occupational Performance Measure
Time frame: Baseline and immediately after completion of the 10-session intervention
Satisfaction with performance for each prioritized activity is rated on a scale from 1 to 10, with higher scores indicating greater satisfaction. The mean satisfaction score will be calculated. Change will be determined by comparing baseline and post-intervention scores.
Performance Quality Rating Scale
Time frame: Baseline and immediately after completion of the 10-session intervention
The Performance Quality Rating Scale is an observational measure used to rate the quality of performance of individualized activities. Performance is rated from 1 to 10, with higher scores indicating better performance quality. Each participant's selected occupational goals will be rated at baseline and after the intervention.
2 secondary outcomes
Goal Attainment Scale
Time frame: Baseline and immediately after completion of the 10-session intervention
Childhood Autism Rating Scale
Time frame: Baseline and immediately after completion of the 10-session intervention
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 21 Jul 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.
Ceren Davutoğlu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Orientation to Daily Occupational Performance Approach in people with Autism Spectrum Disorder, run by Atlas 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 6 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: looking for participants now, as of the sponsor's last update on 21 Jul 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 Zeynep Çorakcı Yazıcıoğlu (+905376699979, zcorakci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (time frame: Baseline and immediately after completion of the 10-session intervention). 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 21 Jul 2026.