- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07253558
Effects of Music-Based Occupational Therapy on Attention and Executive Functions in Children With ADHD (MBOT-ADHD)
Effects of Music-Based Occupational Therapy Activities on Attention and Executive Functions in Children With Attention Deficit and Hyperactivity Disorder
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Beykoz
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Istanbul, Beykoz, Turkey (Türkiye), 34820
- Istanbul Medipol University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music-Based Occupational Therapy
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline and 6 weeks after intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Executive Function Skills
Time Frame: Baseline and 6 weeks after intervention.
|
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.
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Baseline and 6 weeks after intervention.
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|
Caregiver Burden Level
Time Frame: Baseline and 6 weeks after intervention.
|
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.
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Baseline and 6 weeks after intervention.
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-2028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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