Attention Deficit and Hyperactivity Disorder (ADHD)MBOT-ADHDNCT07253558
Effects of Music-Based Occupational Therapy on Attention and Executive Functions in Children With ADHD
A study testing Music-Based Occupational Therapy in people with Attention Deficit and Hyperactivity Disorder (ADHD), run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Attention Deficit/Hyperactivity Disorder (ADHD) is a neurodevelopmental condition that affects children's attention, behavior, and emotional regulation. This study examined whether occupational therapy sessions that include structured music activities can improve attention and executive functions in children with ADHD… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Attention Deficit and Hyperactivity Disorder (ADHD)
- What is being tested?
- Music-Based Occupational Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2022to 30 Apr 2023
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of ADHD
- Being between 5 and 12 years of age.
- Residing in Istanbul.
- The caregiver scoring 21 or above on the Parental Stress Index (PSI).
- The caregiver being between 18 and 65 years of age
Who cannot join
- Having an additional diagnosis accompanying ADHD.
- Having experienced a cardiopulmonary problem within the last 3 months.
- Having previously learned to play a musical instrument.
- The caregiver scoring 31 or above on the Beck Depression Inventory (BDI).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Beykoz, 34820
About this study
Official title: Effects of Music-Based Occupational Therapy Activities on Attention and Executive Functions in Children With Attention Deficit and Hyperactivity Disorder
Attention Deficit/Hyperactivity Disorder (ADHD) is a neurodevelopmental condition that affects children's attention, behavior, and emotional regulation. This study examined whether occupational therapy sessions that include structured music activities can improve attention and executive functions in children with ADHD compared to standard occupational therapy. Thirty-nine children aged 6 to 17 participated and were randomly assigned to two groups. The music-based group received 45-minute sessions once a week for six weeks using harmonica and drum activities, while the control group received standard occupational therapy. Children's attention, executive skills, and caregiver stress were measured before and after the intervention using standardized parent-report scales. Both groups improved after therapy, but the music-based occupational therapy group showed greater gains in attention.
Read the detailed description
Attention Deficit/Hyperactivity Disorder (ADHD) is a complex neurodevelopmental condition that affects attention, motor control, and executive functioning. In addition to pharmacological approaches, behavioral and sensory-based occupational therapy interventions are increasingly being used to support self-regulation and participation in daily activities.
This randomized controlled study was conducted to evaluate the effects of occupational therapy-based music activities on attention, executive functions, and caregiver burden in children with ADHD. Thirty-nine children aged 6-17 years with a clinical diagnosis of ADHD were included. Participants were randomly assigned to the experimental group (occupational therapy-based music; n=19) or the control group (standard occupational therapy; n=20). The intervention group received 45-minute sessions once a week for six consecutive weeks. The sessions incorporated harmonica and drum activities to enhance rhythmic coordination, sensory processing, and cognitive engagement within the occupational therapy framework. The control group received standard occupational therapy during the same period, focusing on activity organization, attention training, and behavioral strategies. Outcome measures were collected at baseline and at the end of the sixth week. Attention was assessed with the DSM-V Level 2 Inattention Scale, executive functions with the Childhood Executive Function Inventory (CHEXI), and caregiver burden with the Zarit Caregiver Burden Scale. Statistical analyses revealed significant improvements in all variables in both groups, with a greater effect on attention levels in the music-based occupational therapy group. These findings suggest that structured music-based occupational therapy can be an effective complementary intervention to improve attention, executive function, and family well-being in children with ADHD.
- Being tested
- Music-Based Occupational Therapy
- Keywords
- ADHD, Attention, Caregiver, Executive functions, Music-based activities
- 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.
Music-Based Occupational TherapyBehavioural
This behavioral intervention consisted of six weeks of occupational therapy-based music sessions lasting 45 minutes each, performed once a week. The intervention involved therapeutic use of harmonica and drums integrated into occupational therapy sessions to support sensory processing, attention, and motor planning in children with ADHD. The approach focused on enhancing attention, executive function, play skills, and self-regulation through rhythm-based sensory and motor engagement.
| Study group | Role | What they receive |
|---|---|---|
| Music-Based Occupational Therapy | Experimental | Participants in the experimental group received music-based occupational therapy for children with ADHD. The sessions were held once a week for six weeks, each lasting approximately 45 minutes. During the sessions, occupational therapy-based music activities were conducted using harmonicas and drums. These instruments were selected for their therapeutic potential to enhance fine motor skills, provide oral-motor sensory input, and promote rhythmic coordination. Sessions were conducted individually in a clinical environment and aimed to improve attention, executive functions, and caregiver-related outcomes. Receives: Behavioral: Music-Based Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention Performance
Change in attention performance of children with ADHD after six weeks of music-based occupational therapy. Attention levels are assessed using the DSM-V Level 2 Inattention Scale, an 8-item parent-report questionnaire that evaluates inattention symptoms during the past seven days. The DSM-5 Level 2 Inattention Scale provides a four-point Likert-type assessment for screening inattention (0 = none, 1 = a little, 2 = quite a bit, 3 = very much). The sum of the scores obtained from the eight items can range between 0 and 24. A higher score indicates greater severity of inattention.
Measured: Baseline and 6 weeks after intervention.
Secondary outcomes (2)
Executive Function Skills
Change in executive function skills, including working memory, inhibition, planning, and regulation, after six weeks of music-based occupational therapy. Executive functions are assessed using the Childhood Executive Functioning Inventory (CHEXI) - Parent Form. The CHEXI (Childhood Executive Function Inventory), which consists of 26 items, is divided into four subscales: working memory (9 items), planning (6 items), inhibition (6 items), and regulation (5 items). The questions are answered by either parents or teachers. Each item uses a 1-to-5 scale to rate the degree of accuracy of the statement (1: absolutely not true, 5: absolutely true). The parent is asked to indicate how well the child fits that statement by selecting the appropriate number. As the total score obtained from the CHEXI increases, the child's executive functions weaken.
Measured: Baseline and 6 weeks after intervention.
Caregiver Burden Level
Change in caregiver burden levels after the six-week music-based occupational therapy program. Caregiver burden is assessed using the Zarit Burden Interview (ZBI), which measures the physical, emotional, and social impact of care responsibilities on the primary caregiver. The total score of the scale ranges between 19 and 95, and the higher the score, the higher the burden experienced by the individual.
Measured: Baseline and 6 weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start30 Apr 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
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 Attention Deficit and Hyperactivity Disorder (ADHD)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study was based on an occupational therapy-centered intervention model designed to enhance attention and executive functioning skills in children with attention deficit hyperactivity disorder (ADHD). The intervention model consisted of two structured therapeutic approaches. The first, the Occupational Therapy-Based Music Activity Model, integrated core principles of sensory integration, motor planning, and emotional regulation through rhythmic and interactive musical experiences. This approach emphasized active engagement, auditory-motor coordination, and task-oriented participation, aiming to support sustained attention, impulse control, and goal-directed behavior. The music-based sessions were delivered by an occupational therapist using structured group activities involving rhythm instruments, body movements, and attention-focused musical games. The second model, the Structured Occupational Therapy ADHD Protocol, served as the control intervention and was developed in accordance
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University
- Responsible party
- Principal investigator, Ibrahim Erarslan, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253558
- Sponsor's protocol ID
- E-10840098-772.02-2028
- Acronym
- MBOT-ADHD
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical considerations and privacy protection of child participants. The data include sensitive clinical and psychological information that cannot be anonymized sufficiently for open sharing. Only aggregated results will be reported in publications.
Publications
Yeniceli D, Sener E, Korkmaz OT, Dogrukol-Ak D, Tuncel N. A simple and sensitive LC-ESI-MS (ion trap) method for the determination of bupropion and its major metabolite, hydroxybupropion in rat plasma and brain microdialysates. Talanta. 2011 Mar 15;84(1):19-26. doi: 10.1016/j.talanta.2010.11.063. Epub 2010 Dec 21.
PubMed 21315892
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music-Based Occupational Therapy Activities on Attention and Executive Functions in Children With Attention Deficit and Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT07253558
- Acronym / sponsor ID
- MBOT-ADHD / E-10840098-772.02-2028
- Keywords
- ADHD, Attention, Caregiver, Executive functions, Music-based activities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Rutgers University
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 28 Nov 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.
Attention Deficit/Hyperactivity Disorder (ADHD) is a neurodevelopmental condition that affects children's attention, behavior, and emotional regulation. This study examined whether occupational therapy sessions that include structured music activities can improve attention and executive functions in children with ADHD compared to standard occupational therapy. Thirty-nine children aged 6 to 17 participated and were randomly assigned to two groups. The music-based group received 45-minute sessions once a week for six weeks using harmonica and drum activities, while the control group received standard occupational therapy. Children's attention, executive skills, and caregiver stress were measured before and after the intervention using standardized parent-report scales. Both groups improved after therapy, but the music-based occupational therapy group showed greater gains in attention.
Detailed description
Attention Deficit/Hyperactivity Disorder (ADHD) is a complex neurodevelopmental condition that affects attention, motor control, and executive functioning. In addition to pharmacological approaches, behavioral and sensory-based occupational therapy interventions are increasingly being used to support self-regulation and participation in daily activities.
This randomized controlled study was conducted to evaluate the effects of occupational therapy-based music activities on attention, executive functions, and caregiver burden in children with ADHD. Thirty-nine children aged 6-17 years with a clinical diagnosis of ADHD were included. Participants were randomly assigned to the experimental group (occupational therapy-based music; n=19) or the control group (standard occupational therapy; n=20). The intervention group received 45-minute sessions once a week for six consecutive weeks. The sessions incorporated harmonica and drum activities to enhance rhythmic coordination, sensory processing, and cognitive engagement within the occupational therapy framework. The control group received standard occupational therapy during the same period, focusing on activity organization, attention training, and behavioral strategies. Outcome measures were collected at baseline and at the end of the sixth week. Attention was assessed with the DSM-V Level 2 Inattention Scale, executive functions with the Childhood Executive Function Inventory (CHEXI), and caregiver burden with the Zarit Caregiver Burden Scale. Statistical analyses revealed significant improvements in all variables in both groups, with a greater effect on attention levels in the music-based occupational therapy group. These findings suggest that structured music-based occupational therapy can be an effective complementary intervention to improve attention, executive function, and family well-being in children with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study was based on an occupational therapy-centered intervention model designed to enhance attention and executive functioning skills in children with attention deficit hyperactivity disorder (ADHD). The intervention model consisted of two structured therapeutic approaches. The first, the Occupational Therapy-Based Music Activity Model, integrated core principles of sensory integration, motor planning, and emotional regulation through rhythmic and interactive musical experiences. This approach emphasized active engagement, auditory-motor coordination, and task-oriented participation, aiming to support sustained attention, impulse control, and goal-directed behavior. The music-based sessions were delivered by an occupational therapist using structured group activities involving rhythm instruments, body movements, and attention-focused musical games. The second model, the Structured Occupational Therapy ADHD Protocol, served as the control intervention and was developed in accordance
| Arm | Type | Receives |
|---|---|---|
| Music-Based Occupational Therapy | Experimental | Behavioral: Music-Based Occupational TherapyParticipants in the experimental group received music-based occupational therapy for children with ADHD. The sessions were held once a week for six weeks, each lasting approximately 45 minutes. During the sessions, occupational therapy-based music activities were conducted using harmonicas and drums. These instruments were selected for their therapeutic potential to enhance fine motor skills, provide oral-motor sensory input, and promote rhythmic coordination. Sessions were conducted individually in a clinical environment and aimed to improve attention, executive functions, and caregiver-related outcomes. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinical diagnosis of ADHD
- Being between 5 and 12 years of age.
- Residing in Istanbul.
- The caregiver scoring 21 or above on the Parental Stress Index (PSI).
- The caregiver being between 18 and 65 years of age
Key exclusion criteria (4 listed)
- Having an additional diagnosis accompanying ADHD.
- Having experienced a cardiopulmonary problem within the last 3 months.
- Having previously learned to play a musical instrument.
- The caregiver scoring 31 or above on the Beck Depression Inventory (BDI).
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 |
|---|---|---|
| Music-Based Occupational TherapyThis behavioral intervention consisted of six weeks of occupational therapy-based music sessions lasting 45 minutes each, performed once a week. The intervention involved therapeutic use of harmonica and drums integrated into occupational therapy sessions to support sensory processing, attention, and motor planning in children with ADHD. The approach focused on enhancing attention, executive function, play skills, and self-regulation through rhythm-based sensory and motor engagement. | Behavioural | Music-Based Occupational Therapy |
Primary outcome
Attention Performance
Time frame: Baseline and 6 weeks after intervention.
Change in attention performance of children with ADHD after six weeks of music-based occupational therapy. Attention levels are assessed using the DSM-V Level 2 Inattention Scale, an 8-item parent-report questionnaire that evaluates inattention symptoms during the past seven days. The DSM-5 Level 2 Inattention Scale provides a four-point Likert-type assessment for screening inattention (0 = none, 1 = a little, 2 = quite a bit, 3 = very much). The sum of the scores obtained from the eight items can range between 0 and 24. A higher score indicates greater severity of inattention.
2 secondary outcomes
Executive Function Skills
Time frame: Baseline and 6 weeks after intervention.
Caregiver Burden Level
Time frame: Baseline and 6 weeks after intervention.
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 28 Nov 2025.
- Background: PubMed 21315892Yeniceli D, Sener E, Korkmaz OT, Dogrukol-Ak D, Tuncel N. A simple and sensitive LC-ESI-MS (ion trap) method for the determination of bupropion and its major metabolite, hydroxybupropion in rat plasma and brain microdialysates. Talanta. 2011 Mar 15;84(1):19-26. doi: 10.1016/j.talanta.2010.11.063. Epub 2010 Dec 21.
- Case report published in Cureus related to therapeutic interventions in ADHD (PDF).Link provided by the sponsor.
- Research article published in DergiPark related to occupational therapy-based interventions in children with ADHD.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical considerations and privacy protection of child participants. The data include sensitive clinical and psychological information that cannot be anonymized sufficiently for open sharing. Only aggregated results will be reported in publications.
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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 Music-Based Occupational Therapy in people with Attention Deficit and Hyperactivity Disorder (ADHD), run by Istanbul Medipol University Hospital 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 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 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?
Attention Performance (time frame: Baseline and 6 weeks after intervention.). 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 NCT07253558, 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 28 Nov 2025.