Cognitive OrientationNCT05125120
THE EFFECT OF THE COGNITIVE ORIENTATION TO DAILY OCCUPATIONAL PERFORMANCE (CO-OP) APPROACH IN CHILDREN WITH ATTENTION DEFICIT AND HYPERACTIVITY DISORDER ON MOTOR PERFORMANCE AND EXECUTIVE FUNCTIONS
A study testing COGNİTİVE ORİENTATİTON DAİLY OCCUPATİONAL PERFORMANCE APPROACH in people with Cognitive Orientation and Executive Dysfunction, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Attention deficit and hyperactivity disorder (ADHD) is a behavioural and neurodevelopmental disorder that can affect behavioural, emotional, academic, social, and cognitive functions and is not age-appropriate. The prevalence of ADHD among school children is reported to be 3%-11%. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Orientation, Executive Dysfunction, Motor Activity
- What is being tested?
- COGNİTİVE ORİENTATİTON DAİLY OCCUPATİONAL PERFORMANCE APPROACH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 30 Dec 2021
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child is between 7 and 12 years old
- Meeting the diagnostic criteria for ADHD
- Continuing drug therapy with methylphenidate
- Attending school
Who cannot join
- Having a mental, chronic neurological or orthopedic disorder in addition to ADHD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF THE COGNITIVE ORIENTATION TO DAILY OCCUPATIONAL PERFORMANCE (CO-OP) APPROACH IN CHILDREN WITH ATTENTION DEFICIT AND HYPERACTIVITY DISORDER ON MOTOR PERFORMANCE AND EXECUTIVE FUNCTIONS: A RANDOMIZED CONTROLLED STUDY
Attention deficit and hyperactivity disorder (ADHD) is a behavioural and neurodevelopmental disorder that can affect behavioural, emotional, academic, social, and cognitive functions and is not age-appropriate. The prevalence of ADHD among school children is reported to be 3%-11%. Children with ADHD have difficulties paying attention to details, concentrating, completing tasks and following instructions, among other social and academic challenges. In children with ADHD, insufficient activity in the prefrontal regions of the brain has been evidenced, which is linked to executive function skills. Such children have difficulties in performing executive functions that require a high level of cognitive skills, such as self-control and regulation, as well as sequencing and planning tasks. The Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) addresses executive dysfunction as a characteristic of ADHD. At the same time, 45%-70% of these children show problems in motor skills. Motor problems associated with ADHD, such as manual dexterity, bilateral coordination, and postural balance, can lead to difficulty in everyday living tasks, such as eating and writing, as well as social adaptability, academic skills, and peer interactions. For this reason, motor skill problems along with symptoms of inattention, hyperactivity, and impulsivity, should be addressed as part of the treatment strategy. ADHD has an impact on a child's independence for daily activities. As a result, child-specific occupational therapy approaches are critical for the sensory, motor, and cognitive areas that affect children's occupational performance in basic and instrumental activities of daily living, participation, rest and sleep, play, and leisure.
Read the detailed description
Afyonkarahisar University of Health Sciences Non-Invasive Clinical Research Ethics Committee evaluated the study with the 2011-KAEK-2 ethics committee code. The study was planned to be carried out in Afyonkarahisar State Hospital Occupational Therapy Unit. It was planned to include 30 children between the ages of 7 and 12 who were diagnosed with ADHD according to the DSM-5 criteria by a child psychiatrist. Children will be randomly divided into two groups: 15 in the intervention group and 15 in the control group. At the beginning of the study, the purpose of the study will be explained to the family and the child and informed consent forms will be signed. Standard tests will be applied after the sociodemographic information of the child and his family is obtained. With the CO-OP approach, the intervention group will receive two sessions of therapy per week, each for approximately one hour, for a total of 6 weeks and 12 sessions. After 6 weeks, standard assessments will be repeated. The control group will receive the same standardized assessments at baseline and 6 weeks later with no further intervention.
- Conditions
- Cognitive Orientation, Executive Dysfunction, Motor Activity
- Being tested
- COGNİTİVE ORİENTATİTON DAİLY OCCUPATİONAL PERFORMANCE APPROACH
- Medical subject headings
- Orientation, Spatial, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COGNİTİVE ORİENTATİTON DAİLY OCCUPATİONAL PERFORMANCE APPROACHOther
Polatajko et al. (2001) developed the CO-OP approach, which is an occupation-oriented problem-solving approach that combines cognitive strategies to help children acquire motor abilities throughout daily tasks (9, 29). The CO-OP approach of therapy focuses on the goal or task at hand rather than the acquisition of functions in occupational performance. CO-OP is a 'deductive' or 'occupational performance-oriented' approach that focuses on the activity target selected throughout the therapy, as opposed to 'inductive' or 'impairment-focused' alternatives (13). As a verbal approach, CO-OP focuses on skill acquisition at the activity level and strives to provide children with global problem-solving skills. Necessary performance strategies specific to the child and the activity are determined with a customised programme (12, 30). Skill acquisition, cognitive strategy development, and adapting and transferring these acquired skills to daily life are the three key goals of the approach.
| Study group | Role | What they receive |
|---|---|---|
| Attention Deficit and Hyperactivity Disorder | Other | Attention Deficit and Hyperactivity Disorder (CO-OP Group) Attention Deficit and Hyperactivity Disorder (Control Group) Receives: Other: COGNİTİVE ORİENTATİTON DAİLY OCCUPATİONAL PERFORMANCE APPROACH |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Canadian Occupational Performance Measure (COPM)
It is an client-centred semi-structured interview method in which individuals score their performance and satisfaction in the activities that they need, want, or are required to accomplish in the areas of self-care, productivity, and leisure (17, 18). On a 10-point scale (1=not able to do=not satisfied at all, 10=can be done=pleased), the individual ranks the activities that he or she considers significant for themselves separately in terms of performance and satisfaction
Measured: five weeks
Goal Attainment Scaling (GAS)
It is used to determine whether children have met their functional activity goals. It's critical that the objectives are clear, measurable, and well-timed (21, 22). The various achievable results for each aim are defined independently at five levels while scoring the GAS: -2, -1, 0, +1, and +2. The initial level is -2, and the child's level is re-evaluated after the application
Measured: five weeks
The Bruininks-Oseretsky Test of Motor Proficiency and Performance-Short Form (BOTMP-SF)
The BOTMP-SF which was modified from the long version and is used to assess children's motor abilities, has 14 items and a maximum score of 98. BOTMP-SF assesses upper extremity coordination, balance, visual-motor control, and other skills in three areas: gross motor, gross-fine motor, and fine motor
Measured: five weeks
The Executive Functions and Occupational Routines Scale (EFORTS)
This scale is used to assess executive function skills and activity routines of children aged 6-12 years, including impulsivity, verbal and nonverbal memory, self-regulation, planning, and problem-solving. It is divided into three sections: morning-evening routine, game-entertainment routines, and social routines
Measured: five weeks
Visual Analogue Scale (VAS)
The VAS is a scale for converting some values that are difficult to measure numerically into numerical data. The participant uses a vertical line on a 0-10 cm scale to denote his or her emotional state, and the distance is measured with a ruler. The VAS was used to measure the level of satisfaction of families with therapy in this study.
Measured: five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Mar 2020
- Primary completion30 Sep 2021
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive OrientationStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEDANUR GÜRLEK, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125120
- Sponsor's protocol ID
- HU.SGURLEK.001
- Status last verified
- Nov 2021
- First submitted
- 24 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gurlek S, Bumin G. The effect of cognitive orientation to daily occupational performance in children with attention deficit hyperactivity disorder: A pilot randomized controlled study. Appl Neuropsychol Child. 2026 Apr-Jun;15(2):169-178. doi: 10.1080/21622965.2024.2385679. Epub 2024 Jul 31.
PubMed 39081141
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF THE COGNITIVE ORIENTATION TO DAILY OCCUPATIONAL PERFORMANCE (CO-OP) APPROACH IN CHILDREN WITH ATTENTION DEFICIT AND HYPERACTIVITY DISORDER ON MOTOR PERFORMANCE AND EXECUTIVE FUNCTIONS: A RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT05125120
- Acronym / sponsor ID
- HU.SGURLEK.001
- Conditions
- Cognitive Orientation, Executive Dysfunction, Motor Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 18 Nov 2021 (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.
Attention deficit and hyperactivity disorder (ADHD) is a behavioural and neurodevelopmental disorder that can affect behavioural, emotional, academic, social, and cognitive functions and is not age-appropriate. The prevalence of ADHD among school children is reported to be 3%-11%. Children with ADHD have difficulties paying attention to details, concentrating, completing tasks and following instructions, among other social and academic challenges. In children with ADHD, insufficient activity in the prefrontal regions of the brain has been evidenced, which is linked to executive function skills. Such children have difficulties in performing executive functions that require a high level of cognitive skills, such as self-control and regulation, as well as sequencing and planning tasks. The Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) addresses executive dysfunction as a characteristic of ADHD. At the same time, 45%-70% of these children show problems in motor skills. Motor problems associated with ADHD, such as manual dexterity, bilateral coordination, and postural balance, can lead to difficulty in everyday living tasks, such as eating and writing, as well as social adaptability, academic skills, and peer interactions. For this reason, motor skill problems along with symptoms of inattention, hyperactivity, and impulsivity, should be addressed as part of the treatment strategy. ADHD has an impact on a child's independence for daily activities. As a result, child-specific occupational therapy approaches are critical for the sensory, motor, and cognitive areas that affect children's occupational performance in basic and instrumental activities of daily living, participation, rest and sleep, play, and leisure.
Detailed description
Afyonkarahisar University of Health Sciences Non-Invasive Clinical Research Ethics Committee evaluated the study with the 2011-KAEK-2 ethics committee code. The study was planned to be carried out in Afyonkarahisar State Hospital Occupational Therapy Unit. It was planned to include 30 children between the ages of 7 and 12 who were diagnosed with ADHD according to the DSM-5 criteria by a child psychiatrist. Children will be randomly divided into two groups: 15 in the intervention group and 15 in the control group. At the beginning of the study, the purpose of the study will be explained to the family and the child and informed consent forms will be signed. Standard tests will be applied after the sociodemographic information of the child and his family is obtained. With the CO-OP approach, the intervention group will receive two sessions of therapy per week, each for approximately one hour, for a total of 6 weeks and 12 sessions. After 6 weeks, standard assessments will be repeated. The control group will receive the same standardized assessments at baseline and 6 weeks later with no further intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Attention Deficit and Hyperactivity Disorder | Other | Other: COGNİTİVE ORİENTATİTON DAİLY OCCUPATİONAL PERFORMANCE APPROACHAttention Deficit and Hyperactivity Disorder (CO-OP Group) Attention Deficit and Hyperactivity Disorder (Control Group) |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The child is between 7 and 12 years old
- Meeting the diagnostic criteria for ADHD
- Continuing drug therapy with methylphenidate
- Attending school
Key exclusion criteria (1 listed)
- Having a mental, chronic neurological or orthopedic disorder in addition to ADHD
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 |
|---|---|---|
| COGNİTİVE ORİENTATİTON DAİLY OCCUPATİONAL PERFORMANCE APPROACHPolatajko et al. (2001) developed the CO-OP approach, which is an occupation-oriented problem-solving approach that combines cognitive strategies to help children acquire motor abilities throughout daily tasks (9, 29). The CO-OP approach of therapy focuses on the goal or task at hand rather than the acquisition of functions in occupational performance. CO-OP is a 'deductive' or 'occupational performance-oriented' approach that focuses on the activity target selected throughout the therapy, as opposed to 'inductive' or 'impairment-focused' alternatives (13). As a verbal approach, CO-OP focuses on skill acquisition at the activity level and strives to provide children with global problem-solving skills. Necessary performance strategies specific to the child and the activity are determined with a customised programme (12, 30). Skill acquisition, cognitive strategy development, and adapting and transferring these acquired skills to daily life are the three key goals of the approach. | Other | Attention Deficit and Hyperactivity Disorder |
Primary outcome
The Canadian Occupational Performance Measure (COPM)
Time frame: five weeks
It is an client-centred semi-structured interview method in which individuals score their performance and satisfaction in the activities that they need, want, or are required to accomplish in the areas of self-care, productivity, and leisure (17, 18). On a 10-point scale (1=not able to do=not satisfied at all, 10=can be done=pleased), the individual ranks the activities that he or she considers significant for themselves separately in terms of performance and satisfaction
Goal Attainment Scaling (GAS)
Time frame: five weeks
It is used to determine whether children have met their functional activity goals. It's critical that the objectives are clear, measurable, and well-timed (21, 22). The various achievable results for each aim are defined independently at five levels while scoring the GAS: -2, -1, 0, +1, and +2. The initial level is -2, and the child's level is re-evaluated after the application
The Bruininks-Oseretsky Test of Motor Proficiency and Performance-Short Form (BOTMP-SF)
Time frame: five weeks
The BOTMP-SF which was modified from the long version and is used to assess children's motor abilities, has 14 items and a maximum score of 98. BOTMP-SF assesses upper extremity coordination, balance, visual-motor control, and other skills in three areas: gross motor, gross-fine motor, and fine motor
The Executive Functions and Occupational Routines Scale (EFORTS)
Time frame: five weeks
This scale is used to assess executive function skills and activity routines of children aged 6-12 years, including impulsivity, verbal and nonverbal memory, self-regulation, planning, and problem-solving. It is divided into three sections: morning-evening routine, game-entertainment routines, and social routines
Visual Analogue Scale (VAS)
Time frame: five weeks
The VAS is a scale for converting some values that are difficult to measure numerically into numerical data. The participant uses a vertical line on a 0-10 cm scale to denote his or her emotional state, and the distance is measured with a ruler. The VAS was used to measure the level of satisfaction of families with therapy in this study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Derived from this study: PubMed 39081141Gurlek S, Bumin G. The effect of cognitive orientation to daily occupational performance in children with attention deficit hyperactivity disorder: A pilot randomized controlled study. Appl Neuropsychol Child. 2026 Apr-Jun;15(2):169-178. doi: 10.1080/21622965.2024.2385679. Epub 2024 Jul 31.
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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 COGNİTİVE ORİENTATİTON DAİLY OCCUPATİONAL PERFORMANCE APPROACH in people with Cognitive Orientation and Executive Dysfunction, run by Hacettepe 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 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: status not confirmed, as of the sponsor's last update on 18 Nov 2021. 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?
Results are not available in the source record.
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 Canadian Occupational Performance Measure (COPM) (time frame: five weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05125120, which also lists 1 linked publication.
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 Nov 2021.