NCT07253558

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 14, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

ADHDAttentionCaregiverExecutive functionsMusic-based activities

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 6 weeks after intervention.

Secondary Outcomes (2)

  • Executive Function Skills

    Baseline and 6 weeks after intervention.

  • Caregiver Burden Level

    Baseline and 6 weeks after intervention.

Study Arms (1)

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.

Behavioral: Music-Based Occupational Therapy

Interventions

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.

Music-Based Occupational Therapy

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Beykoz, 34820, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 21315892BACKGROUND

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Not applicable. This is an open-label single-arm study. The intervention was openly delivered to all participants by the same occupational therapist. No blinding was applied to participants or outcome assessors.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Research Assistant, Department of Occupational Therapy, Istanbul Medipol University; PhD Student, Health Sciences University

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 28, 2025

Study Start

April 30, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations