ADHDNCT05063669
Cognitive Intervention in Attention Deficit and Hyperactivity Disorder
A study testing Cognitive Occupational Therapy in people with ADHD and Cognitive Deficit, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Attention Deficit Hyperactivity Disorder is a disorder in which children show insufficient attention span, hyperactivity and impulsivity according to their developmental level. It is stated that in the absence of rehabilitation, the child's social and academic functionality gradually deteriorates, there are problems… Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- ADHD, Cognitive Deficit
- What is being tested?
- Cognitive Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 30 Dec 2020
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 9-12 years
- Clinical diagnosis of ADHD according to DSM-V criteria by a psychiatrist
- Not taking any medication for ADHD or taking a fixed dose 3 months ago
Who cannot join
- Any medical or mental health problems
- Any secondary diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cognitive Occupational Therapy Interventions on Executive Functions in Children With Attention Deficit and Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder is a disorder in which children show insufficient attention span, hyperactivity and impulsivity according to their developmental level. It is stated that in the absence of rehabilitation, the child's social and academic functionality gradually deteriorates, there are problems in cognitive function processes and executive dysfunctions that affect daily life. The aim of this study was to investigate the effects of cognitive occupational therapy interventions on executive functions in children with Attention Deficit and Hyperactivity Disorder. 21 children aged 9-12 years were included in the research (10 study group-11 control group). One individual and one group session was applied to the study group at Biruni University Occupational Therapy Unit as 2 times per week for 8 weeks. Both groups were evaluated at the beginning and after 8 weeks with Children's Color Trails Test, Verbal Fluency Test and Stroop Test T-Bag Form. Wilcoxon Paired Sample Test and Mann Whitney U Test were used for analysis of intervention results and comparison between groups.
Read the detailed description
Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or growing. In individuals with ADHD, clinical findings may vary depending on development. It is frequently observed that ADHD, which has a progressive character, continues into adulthood after childhood and adolescence.
The study was conducted in Biruni University Occupational Therapy Unit. Since the individuals participating in the study were under the age of 18, an informed consent form was signed by their parents. The research was carried out between June and December 2020. The study included children aged 9-12 years who were diagnosed with ADHD according to DSM-V criteria by a psychiatrist, did not use any medication for ADHD, or were given a fixed dose 3 months ago and did not plan to change their treatment. Children who could not participate in the study because of any medical or mental health problems and who were diagnosed with any secondary diagnosis were excluded. First of all, the sociodemographic form was applied to the participants. The form consisted of questions to determine age, gender, disease history, presence of drugs used continuously, education level of parents, and whether the participant or family member had neurological or psychiatric disorders. Stroop Test T Bag Form (ST-TBAG), The Children's Color Trails Test (CCTT) and Verbal Fluency Test (VFT) were applied to all participants before and after intervention. Occupational therapy applications were carried out 40 minutes, twice a week (one individual session and one group intervention session) and total of 8 weeks. In the sessions, activities aimed at reasoning and empathy skills, problem solving, evaluating emotional cues, evaluating events from different perspectives, providing personal control, delaying reactions, motor planning, visual perception and prolonging attention span were applied. The interventions were varied according to the personal characteristics of the individuals. In group interventions with three or four participants, group games in the form of cooperation or competition were planned to develop motor planning and cognitive strategy and it was aimed to improve children's rapid decision making and adaptation skills.
Research data were evaluated in SPSS 22.0 package program. Mean±standard deviation (X±SD) was determined for the variables determined by measurement. The Wilcoxon Paired Two-Sample Test was used to compare the first and last evaluation data of the intervention and control groups and the Mann Whitney-U test was used to compare the demographic and initial evaluation data of both groups. A significance value of p<0.05 was accepted in all statistical analyses.
- Conditions
- ADHD, Cognitive Deficit
- Being tested
- Cognitive Occupational Therapy
- Keywords
- Attention Deficit and Hyperactivity Disorder, Executive functions, Occupational therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Occupational TherapyBehavioural
In the sessions, activities aimed at reasoning and empathy skills, problem solving, evaluating emotional cues, evaluating events from different perspectives, providing personal control, delaying reactions, motor planning, visual perception and prolonging attention span were applied. The interventions were varied according to the personal characteristics of the individuals. In group interventions with three or four participants, group games in the form of cooperation or competition were planned to develop motor planning and cognitive strategy and it was aimed to improve children's rapid decision making and adaptation skills.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Occupational Therapy | Experimental | Occupational therapy applications were carried out 40 minutes, twice a week (one individual session and one group intervention session) and total of 8 weeks. In the sessions, activities aimed at reasoning and empathy skills, problem solving, evaluating emotional cues, evaluating events from different perspectives, providing personal control, delaying reactions, motor planning, visual perception and prolonging attention span were applied. The interventions were varied according to the personal characteristics of the individuals. In group interventions with three or four participants, group games in the form of cooperation or competition were planned to develop motor planning and cognitive strategy and it was aimed to improve children's rapid decision making and adaptation skills. Receives: Behavioral: Cognitive Occupational Therapy |
| Control | No intervention | No intervention was performed in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop Test T Bag Form
Stroop Test T Bag Form evaluates selective or focused attention and is administered with four 14x21.5 cm white cards. On the first card, random color names (blue, green, red, yellow) are printed in black letters, in a total of 10 rows with five words per line. The second card has the same number of dots printed with these colors, the third card has the same number of color names with the colors written (each written color name is printed in a different color), the fourth card has random words written in different colors.14 Participants were first asked to read the black printed card as fast as possible. The errors and corrections made during this period and the total time spent were recorded. Color names written in color in the second stage, the colors of the shapes in the third stage, word colors without color names in the fourth stage and in the fifth stage, the test was completed by recording the accuracy and duration of saying the word colors, which are the color names.
Measured: 2 weeks
The Children's Color Trails Test
The Children's Color Trails Test was used as a measure in which the first part measures psychomotor speed and the second part evaluates executive function and visuospatial working memory, reflecting the ability to change strategy.
Measured: 2 weeks
Verbal Fluency Test
Verbal Fluency Test VFT is a short screening test that evaluates cognitive function. The two most commonly used variations of the test focus on semantic and phonemic criteria.13 In the first, words in the same semantic field are requested (for example, animals), in the second, it is requested to evoke as many words with the same phoneme as possible (for example, words starting with /a/). One minute was determined for each letter (the letter B is given as an example) and the participant was asked to say every word that can be remembered, provided that there were no proper names starting with the letters K, A and S. Then they were asked to count the fruits, animals and products that could be bought in the supermarket, again for one minute per category and the results were recorded.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start15 Jun 2020
- Primary completion20 Sep 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remziye Akarsu, Biruni University
- Investigators
- Remziye Akarsu, MS, Principal investigator, Biruni UniversityBaşar Öztürk, PhD, Study director, Biruni UniversityAmine Karademir, Bachelor, Study chair, Biruni UniversityMelek Görgülü, Bachelor, Study chair, Biruni UniversityBetül Güler, Bachelor, Study chair, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063669
- Sponsor's protocol ID
- BiruniOccupationalTherapy
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Occupational Therapy Interventions on Executive Functions in Children With Attention Deficit and Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT05063669
- Acronym / sponsor ID
- BiruniOccupationalTherapy
- Conditions
- ADHD, Cognitive Deficit
- Keywords
- Attention Deficit and Hyperactivity Disorder, Executive functions, Occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 1 Oct 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 Hyperactivity Disorder is a disorder in which children show insufficient attention span, hyperactivity and impulsivity according to their developmental level. It is stated that in the absence of rehabilitation, the child's social and academic functionality gradually deteriorates, there are problems in cognitive function processes and executive dysfunctions that affect daily life. The aim of this study was to investigate the effects of cognitive occupational therapy interventions on executive functions in children with Attention Deficit and Hyperactivity Disorder. 21 children aged 9-12 years were included in the research (10 study group-11 control group). One individual and one group session was applied to the study group at Biruni University Occupational Therapy Unit as 2 times per week for 8 weeks. Both groups were evaluated at the beginning and after 8 weeks with Children's Color Trails Test, Verbal Fluency Test and Stroop Test T-Bag Form. Wilcoxon Paired Sample Test and Mann Whitney U Test were used for analysis of intervention results and comparison between groups.
Detailed description
Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or growing. In individuals with ADHD, clinical findings may vary depending on development. It is frequently observed that ADHD, which has a progressive character, continues into adulthood after childhood and adolescence.
The study was conducted in Biruni University Occupational Therapy Unit. Since the individuals participating in the study were under the age of 18, an informed consent form was signed by their parents. The research was carried out between June and December 2020. The study included children aged 9-12 years who were diagnosed with ADHD according to DSM-V criteria by a psychiatrist, did not use any medication for ADHD, or were given a fixed dose 3 months ago and did not plan to change their treatment. Children who could not participate in the study because of any medical or mental health problems and who were diagnosed with any secondary diagnosis were excluded. First of all, the sociodemographic form was applied to the participants. The form consisted of questions to determine age, gender, disease history, presence of drugs used continuously, education level of parents, and whether the participant or family member had neurological or psychiatric disorders. Stroop Test T Bag Form (ST-TBAG), The Children's Color Trails Test (CCTT) and Verbal Fluency Test (VFT) were applied to all participants before and after intervention. Occupational therapy applications were carried out 40 minutes, twice a week (one individual session and one group intervention session) and total of 8 weeks. In the sessions, activities aimed at reasoning and empathy skills, problem solving, evaluating emotional cues, evaluating events from different perspectives, providing personal control, delaying reactions, motor planning, visual perception and prolonging attention span were applied. The interventions were varied according to the personal characteristics of the individuals. In group interventions with three or four participants, group games in the form of cooperation or competition were planned to develop motor planning and cognitive strategy and it was aimed to improve children's rapid decision making and adaptation skills.
Research data were evaluated in SPSS 22.0 package program. Mean±standard deviation (X±SD) was determined for the variables determined by measurement. The Wilcoxon Paired Two-Sample Test was used to compare the first and last evaluation data of the intervention and control groups and the Mann Whitney-U test was used to compare the demographic and initial evaluation data of both groups. A significance value of p<0.05 was accepted in all statistical analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Occupational Therapy | Experimental | Behavioral: Cognitive Occupational TherapyOccupational therapy applications were carried out 40 minutes, twice a week (one individual session and one group intervention session) and total of 8 weeks. In the sessions, activities aimed at reasoning and empathy skills, problem solving, evaluating emotional cues, evaluating events from different perspectives, providing personal control, delaying reactions, motor planning, visual perception and prolonging attention span were applied. The interventions were varied according to the personal characteristics of the individuals. In group interventions with three or four participants, group games in the form of cooperation or competition were planned to develop motor planning and cognitive strategy and it was aimed to improve children's rapid decision making and adaptation skills. |
| Control | No intervention | –No intervention was performed in this group. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 9-12 years
- Clinical diagnosis of ADHD according to DSM-V criteria by a psychiatrist
- Not taking any medication for ADHD or taking a fixed dose 3 months ago
Key exclusion criteria (2 listed)
- Any medical or mental health problems
- Any secondary diagnosis
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 Occupational TherapyIn the sessions, activities aimed at reasoning and empathy skills, problem solving, evaluating emotional cues, evaluating events from different perspectives, providing personal control, delaying reactions, motor planning, visual perception and prolonging attention span were applied. The interventions were varied according to the personal characteristics of the individuals. In group interventions with three or four participants, group games in the form of cooperation or competition were planned to develop motor planning and cognitive strategy and it was aimed to improve children's rapid decision making and adaptation skills. | Behavioural | Cognitive Occupational Therapy |
Primary outcome
Stroop Test T Bag Form
Time frame: 2 weeks
Stroop Test T Bag Form evaluates selective or focused attention and is administered with four 14x21.5 cm white cards. On the first card, random color names (blue, green, red, yellow) are printed in black letters, in a total of 10 rows with five words per line. The second card has the same number of dots printed with these colors, the third card has the same number of color names with the colors written (each written color name is printed in a different color), the fourth card has random words written in different colors.14 Participants were first asked to read the black printed card as fast as possible. The errors and corrections made during this period and the total time spent were recorded. Color names written in color in the second stage, the colors of the shapes in the third stage, word colors without color names in the fourth stage and in the fifth stage, the test was completed by recording the accuracy and duration of saying the word colors, which are the color names.
The Children's Color Trails Test
Time frame: 2 weeks
The Children's Color Trails Test was used as a measure in which the first part measures psychomotor speed and the second part evaluates executive function and visuospatial working memory, reflecting the ability to change strategy.
Verbal Fluency Test
Time frame: 2 weeks
Verbal Fluency Test VFT is a short screening test that evaluates cognitive function. The two most commonly used variations of the test focus on semantic and phonemic criteria.13 In the first, words in the same semantic field are requested (for example, animals), in the second, it is requested to evoke as many words with the same phoneme as possible (for example, words starting with /a/). One minute was determined for each letter (the letter B is given as an example) and the participant was asked to say every word that can be remembered, provided that there were no proper names starting with the letters K, A and S. Then they were asked to count the fruits, animals and products that could be bought in the supermarket, again for one minute per category and the results were recorded.
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 1 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Remziye Akarsu, MS principal investigator
Biruni University
Başar Öztürk, PhD study director
Biruni University
Amine Karademir, Bachelor study chair
Biruni University
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 Occupational Therapy in people with ADHD and Cognitive Deficit, run by Biruni 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 3 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 1 Oct 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?
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?
Stroop Test T Bag Form (time frame: 2 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 1 Oct 2021.