Attention Deficit Hyperactivity DisorderNCT06770725
Investigating the Effects of the Temporal Adaptation Approach in Children With ADHD
A study testing Temporal Adaptation Intervention and Conventional Occupational Therapy in people with Attention Deficit Hyperactivity Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the impact of temporal adaptation interventions on children with Attention Deficit Hyperactivity Disorder (ADHD), focusing on activity self-efficacy, time perception, daily activity routines, and executive functions. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Temporal Adaptation Intervention and Conventional Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2021to 31 Jan 2025
- 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
- Must be between 9 and 12 years of age.
- Clinical diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
- Must be willing to participate and adhere to the study protocols
Who cannot join
- Additional psychiatric or developmental diagnoses that can interfere with the study outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effect of the Temporal Adaptation Approach on Activity Self-Efficacy, Time Perception, and Daily Activity Routine With Executive Skills in Children With ADHD: A 1-Month Follow-Up Randomized Controlled Study
This study investigates the impact of temporal adaptation interventions on children with Attention Deficit Hyperactivity Disorder (ADHD), focusing on activity self-efficacy, time perception, daily activity routines, and executive functions. The intervention aims to address the challenges ADHD children face in time processing abilities, which include understanding the concept of time, being punctual, initiating and completing daily activities independently, planning and completing long-term projects, using a calendar, and hurrying when necessary.
The research will be conducted at the Hacettepe University Faculty of Health Sciences Department of Occupational Therapy's educational and research units. Participants will be children diagnosed with ADHD by a Child and Adolescent Psychiatrist. These children will then be randomly assigned to control and training groups. A total of 60 individuals, 30 for each group, will be included in the study based on power analysis. The effectiveness of the study will be shared, and should it prove effective, the same study will be replicated with the control group.
Read more
The intervention consists of activities designed to enhance temporal adaptation, adapted for ADHD from models in the literature. Over 10 weeks, the children will engage in weekly 60-minute sessions, each week focusing on different activities to improve temporal adaptation skills. Activities include teaching concepts of calendars and clocks, rhythm exercises with metronomes, time estimation games, daily and weekly planner preparation, time matching games, and exercises to improve time management and planning abilities.
Data will be collected using various tools including a demographic information form, time perception threshold measurement tasks, temporal production tasks, Child Activity Self-Assessment Scale (COSA), and Executive Functions and Occupational Routines Scale (EFORTS). The study's hypotheses test the null hypothesis that temporal adaptation intervention does not affect activity self-efficacy, time perception, daily activity routine, and executive functions in children aged 9-12 with ADHD.
This comprehensive approach aims to enhance the daily lives of children with ADHD by improving their ability to manage time effectively, thereby positively affecting their education, self-care, social relationships, and overall quality of life.
Read the detailed description
This study explores the efficacy of a temporal adaptation intervention in enhancing the quality of life and functional abilities of children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a neurodevelopmental disorder characterized by patterns of inattention, impulsivity, and hyperactivity that detrimentally influence an individual's academic, social, motor, sensory, and executive functioning. Notably, children with ADHD often struggle with time processing abilities, which can manifest as difficulties in understanding time concepts, adhering to schedules, and managing daily activities.
Background ADHD significantly impacts the cognitive and behavioural domains of affected children, leading to challenges in daily living and academic achievement. Previous research has identified specific issues in time perception and temporal processing among children with ADHD, including time duration discrimination and time reproduction. These difficulties extend to both the understanding and management of time, impacting their daily routines and task completion. Functional and structural imaging studies have shown that the brain regions involved in time processing overlap with areas implicated in the pathogenesis of ADHD, such as the neocerebellum, basal ganglia, and prefrontal cortex. Given the centrality of time management skills to academic performance, self-care, and social interactions, interventions aimed at improving these skills could significantly enhance the functional outcomes for children with ADHD.
Objective The primary objective of this research is to evaluate the effectiveness of a temporal adaptation intervention aimed at improving activity self-efficacy, time perception, daily activity routines, and executive functions among children with ADHD. The intervention seeks to address the specific temporal processing challenges faced by these children, potentially leading to better time management, planning, and organizational skills.
Methods The intervention will be structured around a series of activities and individual sessions designed based on models of temporal adaptation training adapted for ADHD. These activities will target the development of skills related to the understanding and management of time, such as using calendars and clocks, estimating the duration of activities, and planning and executing daily and long-term tasks.
Setting and Participants The research will be carried out at a university's health sciences faculty, utilizing its educational and research facilities. The study will include children who meet the inclusion criteria of being diagnosed with ADHD, within the age range of 9-12 years, and voluntarily agree to participate. Exclusion criteria include the presence of additional diagnoses and the unwillingness of parents to adhere to the intervention protocols.
Design A randomized controlled trial design will be employed, with participants being randomly assigned to either the intervention or control group. The intervention group will undergo the temporal adaptation training program, while the control group will receive no such training. The training program will span 10 weeks, with sessions held once a week for 60 minutes. Each session will focus on different activities tailored to improve temporal adaptation, such as teaching time concepts, rhythm exercises with a metronome, and games designed to enhance time estimation and planning skills.
Assessment Tools
A comprehensive set of tools will be used to evaluate the impact of the intervention on the participants, including:
Demographic Information Form: To collect baseline demographic data. Time Perception Threshold Measurement: To assess the ability to discriminate between different durations.
Temporal Production Task: To evaluate the accuracy of reproducing time intervals.
Child Activity Self-Assessment Scale (COSA): To measure perceived efficacy and importance in daily activities.
Executive Functions and Occupational Routines Scale (EFORTS): To assess executive functioning and daily routines.
Hypotheses The study will test several hypotheses, including the assumption that the temporal adaptation intervention has no effect on the measured outcomes. The alternative hypothesis posits that the intervention will significantly improve activity self-efficacy, time perception, daily activity routines, and executive functions in participating children.
Data Analysis Statistical analyses will be conducted using appropriate software, with comparisons made between pre- and post-intervention assessments within and between the intervention and control groups. The effectiveness of the intervention will be determined through Cohen's Effect Size, with predefined criteria for interpreting the magnitude of the effect.
Conclusion This study aims to provide evidence on the effectiveness of a temporal adaptation intervention for children with ADHD, focusing on enhancing their ability to understand and manage time. By improving time management and planning skills, the intervention seeks to positively affect educational achievements, self-care, social relationships, and overall quality of life for these children.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Temporal Adaptation Intervention, Conventional Occupational Therapy
- Keywords
- Attention Deficit Hyperactivity Disorder, Temporal Adaptation, Time Management, Time Perception, Occupational self-efficacy, Executive Functions
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Adaptation InterventionBehavioural
The research on temporal adaptation intervention will be conducted through activities and individual sessions within the framework of temporal adaptation intervention. The activities included in the temporal adaptation intervention used in our research have been adapted for ADHD by referencing temporal adaptation training models in the literature.
Conventional Occupational TherapyBehavioural
The control group will be given a 10-week-long conventional occupational therapy intervention by the investigator (Fatma Temizkan). The intervention will consist of occupational therapy approaches such as; obstacle courses, sensory integration, motor skills training, cognitive skills training, sequenced activities and so on.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The participants who are allocated to the Control Group arm will receive conventional occupational therapy interventions for the duration of the study. Receives: Behavioral: Conventional Occupational Therapy |
| Experimental Group | Experimental | Participants allocated to the Experimental Group will receive Temporal Adaptation Intervention during the study. Receives: Behavioral: Temporal Adaptation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Perception Threshold Measurement
Assesses the ability to discriminate between different durations.
Measured: From enrollment to the end of treatment at 10 weeks
Temporal Production Task
Evaluates the accuracy of reproducing time intervals.
Measured: From enrollment to the end of treatment at 10 weeks
Child Occupational Self-Assessment Scale
The Child Occupational Self-Assessment Scale measures perceived efficacy and importance in daily activities. The scale consists of 25 items that evaluate the children's perceived occupational performance and the importance of the occupations under seven areas. All questions are scored from 1 to 4. The scale yields 14 different sub-scores (a performance and an importance score for each area). The Communication and the Executive Functions sub-scores range between 6 and 24, the Motor Skills sub-scores range between 3 and 12, the Academic sub-scores range between 5 and 20 and the Self Regulation, Intrumental Activities of Daily Living and Activities of Daily Living sub-scores range between 2 and 8. For the performance sub-scores, a higher score indicate better perceived performance. For the importance sub-scores, a higher score indicate higher given importance.
Measured: From enrollment to the end of treatment at 10 weeks
Executive Functions and Occupational Routines Scale
The scale ssesses executive functioning and daily routines. The scale consists of 30 items, divided into subscales based on everyday functional routines, scored from 1 (never) to 5 (always). The scale does not have a total score, rather, a mean score is calculated for each sub-scale as well as the total scale. The mean score ranges between 1 and 5, with with higher scores indicating better executive control.
Measured: From enrollment to the end of treatment at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start3 Feb 2021
- Primary completion10 Oct 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Bumin, Hacettepe University
- Investigators
- Gonca Bumin, PhD., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770725
- Sponsor's protocol ID
- 61351342 / ARALIK 2023-06
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that are collected in this study contain individuals' performance scores on various tests, which can be indirectly related to their academic success and overall academic performance. Therefore, the informed consent that is collected from the participants states that their data will not be shared with third parties (any person or institution except for the research team and related ethical boards) except for ethical committees. Therefore, the data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of the Temporal Adaptation Approach on Activity Self-Efficacy, Time Perception, and Daily Activity Routine With Executive Skills in Children With ADHD: A 1-Month Follow-Up Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06770725
- Acronym / sponsor ID
- 61351342 / ARALIK 2023-06
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Temporal Adaptation, Time Management, Time Perception, Occupational self-efficacy, Executive Functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 13 Jan 2025 (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.
This study investigates the impact of temporal adaptation interventions on children with Attention Deficit Hyperactivity Disorder (ADHD), focusing on activity self-efficacy, time perception, daily activity routines, and executive functions. The intervention aims to address the challenges ADHD children face in time processing abilities, which include understanding the concept of time, being punctual, initiating and completing daily activities independently, planning and completing long-term projects, using a calendar, and hurrying when necessary.
The research will be conducted at the Hacettepe University Faculty of Health Sciences Department of Occupational Therapy's educational and research units. Participants will be children diagnosed with ADHD by a Child and Adolescent Psychiatrist. These children will then be randomly assigned to control and training groups. A total of 60 individuals, 30 for each group, will be included in the study based on power analysis. The effectiveness of the study will be shared, and should it prove effective, the same study will be replicated with the control group.
The intervention consists of activities designed to enhance temporal adaptation, adapted for ADHD from models in the literature. Over 10 weeks, the children will engage in weekly 60-minute sessions, each week focusing on different activities to improve temporal adaptation skills. Activities include teaching concepts of calendars and clocks, rhythm exercises with metronomes, time estimation games, daily and weekly planner preparation, time matching games, and exercises to improve time management and planning abilities.
Data will be collected using various tools including a demographic information form, time perception threshold measurement tasks, temporal production tasks, Child Activity Self-Assessment Scale (COSA), and Executive Functions and Occupational Routines Scale (EFORTS). The study's hypotheses test the null hypothesis that temporal adaptation intervention does not affect activity self-efficacy, time perception, daily activity routine, and executive functions in children aged 9-12 with ADHD.
This comprehensive approach aims to enhance the daily lives of children with ADHD by improving their ability to manage time effectively, thereby positively affecting their education, self-care, social relationships, and overall quality of life.
Detailed description
This study explores the efficacy of a temporal adaptation intervention in enhancing the quality of life and functional abilities of children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a neurodevelopmental disorder characterized by patterns of inattention, impulsivity, and hyperactivity that detrimentally influence an individual's academic, social, motor, sensory, and executive functioning. Notably, children with ADHD often struggle with time processing abilities, which can manifest as difficulties in understanding time concepts, adhering to schedules, and managing daily activities.
Background ADHD significantly impacts the cognitive and behavioural domains of affected children, leading to challenges in daily living and academic achievement. Previous research has identified specific issues in time perception and temporal processing among children with ADHD, including time duration discrimination and time reproduction. These difficulties extend to both the understanding and management of time, impacting their daily routines and task completion. Functional and structural imaging studies have shown that the brain regions involved in time processing overlap with areas implicated in the pathogenesis of ADHD, such as the neocerebellum, basal ganglia, and prefrontal cortex. Given the centrality of time management skills to academic performance, self-care, and social interactions, interventions aimed at improving these skills could significantly enhance the functional outcomes for children with ADHD.
Objective The primary objective of this research is to evaluate the effectiveness of a temporal adaptation intervention aimed at improving activity self-efficacy, time perception, daily activity routines, and executive functions among children with ADHD. The intervention seeks to address the specific temporal processing challenges faced by these children, potentially leading to better time management, planning, and organizational skills.
Methods The intervention will be structured around a series of activities and individual sessions designed based on models of temporal adaptation training adapted for ADHD. These activities will target the development of skills related to the understanding and management of time, such as using calendars and clocks, estimating the duration of activities, and planning and executing daily and long-term tasks.
Setting and Participants The research will be carried out at a university's health sciences faculty, utilizing its educational and research facilities. The study will include children who meet the inclusion criteria of being diagnosed with ADHD, within the age range of 9-12 years, and voluntarily agree to participate. Exclusion criteria include the presence of additional diagnoses and the unwillingness of parents to adhere to the intervention protocols.
Design A randomized controlled trial design will be employed, with participants being randomly assigned to either the intervention or control group. The intervention group will undergo the temporal adaptation training program, while the control group will receive no such training. The training program will span 10 weeks, with sessions held once a week for 60 minutes. Each session will focus on different activities tailored to improve temporal adaptation, such as teaching time concepts, rhythm exercises with a metronome, and games designed to enhance time estimation and planning skills.
Assessment Tools
A comprehensive set of tools will be used to evaluate the impact of the intervention on the participants, including:
Demographic Information Form: To collect baseline demographic data. Time Perception Threshold Measurement: To assess the ability to discriminate between different durations.
Temporal Production Task: To evaluate the accuracy of reproducing time intervals.
Child Activity Self-Assessment Scale (COSA): To measure perceived efficacy and importance in daily activities.
Executive Functions and Occupational Routines Scale (EFORTS): To assess executive functioning and daily routines.
Hypotheses The study will test several hypotheses, including the assumption that the temporal adaptation intervention has no effect on the measured outcomes. The alternative hypothesis posits that the intervention will significantly improve activity self-efficacy, time perception, daily activity routines, and executive functions in participating children.
Data Analysis Statistical analyses will be conducted using appropriate software, with comparisons made between pre- and post-intervention assessments within and between the intervention and control groups. The effectiveness of the intervention will be determined through Cohen's Effect Size, with predefined criteria for interpreting the magnitude of the effect.
Conclusion This study aims to provide evidence on the effectiveness of a temporal adaptation intervention for children with ADHD, focusing on enhancing their ability to understand and manage time. By improving time management and planning skills, the intervention seeks to positively affect educational achievements, self-care, social relationships, and overall quality of life for these children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Conventional Occupational TherapyThe participants who are allocated to the Control Group arm will receive conventional occupational therapy interventions for the duration of the study. |
| Experimental Group | Experimental | Behavioral: Temporal Adaptation InterventionParticipants allocated to the Experimental Group will receive Temporal Adaptation Intervention during the study. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Must be between 9 and 12 years of age.
- Clinical diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
- Must be willing to participate and adhere to the study protocols
Key exclusion criteria (1 listed)
- Additional psychiatric or developmental diagnoses that can interfere with the study outcomes
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 |
|---|---|---|
| Temporal Adaptation InterventionThe research on temporal adaptation intervention will be conducted through activities and individual sessions within the framework of temporal adaptation intervention. The activities included in the temporal adaptation intervention used in our research have been adapted for ADHD by referencing temporal adaptation training models in the literature. | Behavioural | Experimental Group |
| Conventional Occupational TherapyThe control group will be given a 10-week-long conventional occupational therapy intervention by the investigator (Fatma Temizkan). The intervention will consist of occupational therapy approaches such as; obstacle courses, sensory integration, motor skills training, cognitive skills training, sequenced activities and so on. | Behavioural | Control Group |
Primary outcome
Time Perception Threshold Measurement
Time frame: From enrollment to the end of treatment at 10 weeks
Assesses the ability to discriminate between different durations.
Temporal Production Task
Time frame: From enrollment to the end of treatment at 10 weeks
Evaluates the accuracy of reproducing time intervals.
Child Occupational Self-Assessment Scale
Time frame: From enrollment to the end of treatment at 10 weeks
The Child Occupational Self-Assessment Scale measures perceived efficacy and importance in daily activities. The scale consists of 25 items that evaluate the children's perceived occupational performance and the importance of the occupations under seven areas. All questions are scored from 1 to 4. The scale yields 14 different sub-scores (a performance and an importance score for each area). The Communication and the Executive Functions sub-scores range between 6 and 24, the Motor Skills sub-scores range between 3 and 12, the Academic sub-scores range between 5 and 20 and the Self Regulation, Intrumental Activities of Daily Living and Activities of Daily Living sub-scores range between 2 and 8. For the performance sub-scores, a higher score indicate better perceived performance. For the importance sub-scores, a higher score indicate higher given importance.
Executive Functions and Occupational Routines Scale
Time frame: From enrollment to the end of treatment at 10 weeks
The scale ssesses executive functioning and daily routines. The scale consists of 30 items, divided into subscales based on everyday functional routines, scored from 1 (never) to 5 (always). The scale does not have a total score, rather, a mean score is calculated for each sub-scale as well as the total scale. The mean score ranges between 1 and 5, with with higher scores indicating better executive control.
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 3 Feb 2025.
- Individual participant dataSharing planned: No. The data that are collected in this study contain individuals' performance scores on various tests, which can be indirectly related to their academic success and overall academic performance. Therefore, the informed consent that is collected from the participants states that their data will not be shared with third parties (any person or institution except for the research team and related ethical boards) except for ethical committees. Therefore, the data will not be shared with other researchers.
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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.
Gonca Bumin, PhD. study director
Hacettepe 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 Temporal Adaptation Intervention and Conventional Occupational Therapy in people with Attention Deficit Hyperactivity Disorder, 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 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: finished, as of the sponsor's last update on 3 Feb 2025. 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?
Time Perception Threshold Measurement (time frame: From enrollment to the end of treatment at 10 weeks). The study lists 4 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 Feb 2025.