Autism Spectrum DisorderNCT06038435
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
A study testing Cognitive Orientation Approach and Ayres Sensory Integration Therapy in people with Autism Spectrum Disorder and Executive Function, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is by using the Cognitive Orientation Approach on Daily Occupational Performance, which is also supported by the literature and applied by occupational therapists, in children diagnosed with Autism Spectrum Disorder, it is aimed to determine how children's executive function scores and… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder, Executive Function, Patient Participation
- What is being tested?
- Cognitive Orientation Approach and Ayres Sensory Integration Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2023to 31 Jan 2024
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being diagnosed with Autism Spectrum Disorder according to DSM-V by the Department of Child and Adolescent Mental Health
- Being between the ages of 7 years and 10 years and 11 months
- Score 30-36 points on the Childhood Autism Rating Scale
- Participation must be approved by the parent.
Who cannot join
- Having a concomitant neurological, psychiatric or orthopedic diagnosis
- Attending a program other than individual education
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, İ̇stanbul, 34762
About this study
Official title: The Effect of Cognitive Orientation Approach on Daily Occupational Performance on Executive Functions and Occupational Participation in Children With Autism Spectrum Disorder: Randomized Controlled Study With 1 Month Follow-up
The goal of this clinical trial is by using the Cognitive Orientation Approach on Daily Occupational Performance, which is also supported by the literature and applied by occupational therapists, in children diagnosed with Autism Spectrum Disorder, it is aimed to determine how children's executive function scores and occupational participation change.
The main questions it aims to answer are:
Read more
- Does the Cognitive Orientation Approach on Daily Occupational Performance have an effect on executive functions?
- Does the Cognitive Orientation Approach on Daily Occupational Performance have an effect on occupational performance?
Participants will:
- Evaluations will be applied to all participants
- Divided into intervention and control groups
- The intervention group will be given "Cognitive Orientation Approach on Daily Occupational Performance" and "Ayres Sensory Integration Therapy" followed up for about 10 weeks.
- The control group will be given "Ayres Sensory Integration Therapy" followed up for about 10 weeks.
- After 10 weeks, the results between the two groups will be compared.
- After the second evaluation, both groups will be followed for 1 month and the same evaluations will be repeated.
Researchers will compare intervention and control groups to see executive functions and occupational participation.
Read the detailed description
Autism spectrum disorder is a complex developmental disorder that can lead to dysfunctions in cognitive, emotion regulation, and communication skills.
At the beginning of the cognitive problems seen in children with autism, the pathophysiology in executive functions, which is affected by individual differences, comes to the fore. Difficulties related to executive functions such as cognitive flexibility and problem solving cause limitations in many basic areas, especially in daily life in autism.
The Cognitive Orientation Approach on Daily Occupational Performance, designed by Polatajko and others, is an activity-oriented problem-solving approach that uses cognitive strategies to develop motor skills in children who have difficulties during daily activities; It is a therapy method that focuses on the goal or the task itself, rather than the acquisition of functions within the activity performance. It is known that the approach is effective on social, emotional and organizational skills, especially cognitive skills in children with autism spectrum disorder.
- Being tested
- Cognitive Orientation Approach, Ayres Sensory Integration Therapy
- Keywords
- Autism Spectrum Disorder, Cognitive Orientation, Ayres Sensory Integration
- Medical subject headings
- Autism Spectrum Disorder, Patient Participation, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Orientation ApproachBehavioural
Cognitive training will be given for the selected occupation
Ayres Sensory Integration TherapyBehavioural
Sensory integration therapy will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Orientation Approach + Ayres Sensory Integration Therapy | Experimental | Cognitive Orientation Approach on Daily Occupational Performance (CO-OP) and Ayres Sensory Integration (ASI) Therapy will be applied together Receives: Behavioral: Cognitive Orientation Approach; Behavioral: Ayres Sensory Integration Therapy |
| Ayres Sensory Integration Therapy Only | Active comparator | Only Ayres Sensory Integration (ASI) Therapy will be applied Receives: Behavioral: Ayres Sensory Integration Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Behavior Rating Inventory of Executive Function
It is a rating used to evaluate the behavior of children and adolescents in the home and school environment, taking into account executive functions. It is a likert scale between 1-3 points and a score between 86-258 is obtained. High score is associated with impaired executive function.
Measured: 10 weeks
The Executive Function and Occupational Routines Scale
It evaluates children's skills such as impulsivity, verbal and non-verbal memory, self-regulation, planning and problem solving. It consists of 4 subtests including the total score. It is obtained by dividing each subtest score by the number of questions. It gives a score between 1-5 points. A high score indicates improvement.
Measured: 10 weeks
The Short Child Occupational Profile
The profile provides a comprehensive assessment of the child's activity participation and a holistic consideration of the factors that facilitate or limit occupational participation. It consists of 7 subtests including the total score. It is a likert scale between 1-4 points. While the "environmental" subtest is between 5-20 points, the other subtests are between 4-16 points. A higher score is associated with increased occupational performance.
Measured: 10 weeks
Secondary outcomes (1)
Canadian Occupational Performance Measure
It is a person-centered approach to establishing treatment goals and assessing perceived performance and satisfaction changes over time. Performance and satisfaction subtests score between 1-5. A higher score is associated with increased occupational performance.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start4 Sep 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
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 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038435
- Sponsor's protocol ID
- CORAKCİ-004
- Status last verified
- Feb 2024
- First submitted
- 7 Sep 2023
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Orientation Approach on Daily Occupational Performance on Executive Functions and Occupational Participation in Children With Autism Spectrum Disorder: Randomized Controlled Study With 1 Month Follow-up
- ClinicalTrials.gov ID
- NCT06038435
- Acronym / sponsor ID
- CORAKCİ-004
- Keywords
- Autism Spectrum Disorder, Cognitive Orientation, Ayres Sensory Integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 14 Sep 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.
The goal of this clinical trial is by using the Cognitive Orientation Approach on Daily Occupational Performance, which is also supported by the literature and applied by occupational therapists, in children diagnosed with Autism Spectrum Disorder, it is aimed to determine how children's executive function scores and occupational participation change.
The main questions it aims to answer are:
- Does the Cognitive Orientation Approach on Daily Occupational Performance have an effect on executive functions?
- Does the Cognitive Orientation Approach on Daily Occupational Performance have an effect on occupational performance?
Participants will:
- Evaluations will be applied to all participants
- Divided into intervention and control groups
- The intervention group will be given "Cognitive Orientation Approach on Daily Occupational Performance" and "Ayres Sensory Integration Therapy" followed up for about 10 weeks.
- The control group will be given "Ayres Sensory Integration Therapy" followed up for about 10 weeks.
- After 10 weeks, the results between the two groups will be compared.
- After the second evaluation, both groups will be followed for 1 month and the same evaluations will be repeated.
Researchers will compare intervention and control groups to see executive functions and occupational participation.
Detailed description
Autism spectrum disorder is a complex developmental disorder that can lead to dysfunctions in cognitive, emotion regulation, and communication skills.
At the beginning of the cognitive problems seen in children with autism, the pathophysiology in executive functions, which is affected by individual differences, comes to the fore. Difficulties related to executive functions such as cognitive flexibility and problem solving cause limitations in many basic areas, especially in daily life in autism.
The Cognitive Orientation Approach on Daily Occupational Performance, designed by Polatajko and others, is an activity-oriented problem-solving approach that uses cognitive strategies to develop motor skills in children who have difficulties during daily activities; It is a therapy method that focuses on the goal or the task itself, rather than the acquisition of functions within the activity performance. It is known that the approach is effective on social, emotional and organizational skills, especially cognitive skills in children with autism spectrum disorder.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Orientation Approach + Ayres Sensory Integration Therapy | Experimental | Behavioral: Cognitive Orientation Approach, Behavioral: Ayres Sensory Integration TherapyCognitive Orientation Approach on Daily Occupational Performance (CO-OP) and Ayres Sensory Integration (ASI) Therapy will be applied together |
| Ayres Sensory Integration Therapy Only | Active comparator | Behavioral: Ayres Sensory Integration TherapyOnly Ayres Sensory Integration (ASI) Therapy will be applied |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being diagnosed with Autism Spectrum Disorder according to DSM-V by the Department of Child and Adolescent Mental Health
- Being between the ages of 7 years and 10 years and 11 months
- Score 30-36 points on the Childhood Autism Rating Scale
- Participation must be approved by the parent.
Key exclusion criteria (2 listed)
- Having a concomitant neurological, psychiatric or orthopedic diagnosis
- Attending a program other than individual education
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 ApproachCognitive training will be given for the selected occupation | Behavioural | Cognitive Orientation Approach + Ayres Sensory Integration Therapy |
| Ayres Sensory Integration TherapySensory integration therapy will be applied. | Behavioural | Ayres Sensory Integration Therapy Only, Cognitive Orientation Approach + Ayres Sensory Integration Therapy |
Primary outcome
The Behavior Rating Inventory of Executive Function
Time frame: 10 weeks
It is a rating used to evaluate the behavior of children and adolescents in the home and school environment, taking into account executive functions. It is a likert scale between 1-3 points and a score between 86-258 is obtained. High score is associated with impaired executive function.
The Executive Function and Occupational Routines Scale
Time frame: 10 weeks
It evaluates children's skills such as impulsivity, verbal and non-verbal memory, self-regulation, planning and problem solving. It consists of 4 subtests including the total score. It is obtained by dividing each subtest score by the number of questions. It gives a score between 1-5 points. A high score indicates improvement.
The Short Child Occupational Profile
Time frame: 10 weeks
The profile provides a comprehensive assessment of the child's activity participation and a holistic consideration of the factors that facilitate or limit occupational participation. It consists of 7 subtests including the total score. It is a likert scale between 1-4 points. While the "environmental" subtest is between 5-20 points, the other subtests are between 4-16 points. A higher score is associated with increased occupational performance.
1 secondary outcome
Canadian Occupational Performance Measure
Time frame: 10 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 7 Feb 2024.
- 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. 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 Cognitive Orientation Approach and Ayres Sensory Integration Therapy in people with Autism Spectrum Disorder and Executive Function, 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 4 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: finished, as of the sponsor's last update on 7 Feb 2024. 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?
The Behavior Rating Inventory of Executive Function (time frame: 10 weeks). The study lists 3 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 7 Feb 2024.