- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07481968
Community-Based Music Mindfulness Intervention on Children
May 12, 2026 updated by: Jamal B. Williams, State University of New York at Buffalo
Evaluating a Community-Based Music Mindfulness Intervention on Psychological and Physiological Outcomes in Children
The goal of this clinical trial is to learn how community-based music mindfulness interventions impact anxiety, depression, and overall emotional well-being in children and adolescents with attention-deficit/hyperactivity disorder and/or anxiety. The main questions it aims to answer are:
- How do participants' psychological states change from the start to the end of the intervention?
- What physiological changes, including heart rate variability and sleep patterns, are observed after the intervention?
- Is this study feasible and acceptable to the community?
Participants will:
- Attend in-person sessions, bi-weekly for 8 weeks
- Regularly complete psychometric assessments
- Wear fitness trackers daily, including overnight, throughout the study period
- Track self-guided intervention online
- Participate in semi-structured interviews pre-/post-study
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jamal B Williams, PhD
- Phone Number: 716-888-4855
- Email: jbwillia@buffalo.edu
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14203
- Clinical Translational Research Center
-
Contact:
- Jamal B Williams, PhD
- Phone Number: 716-888-4875
- Email: jbwillia@buffalo.edu
-
Buffalo, New York, United States, 14215
- Delavan Grider Community Center
-
Contact:
- Deborah Frimpong
- Phone Number: 647-550-7008
- Email: dfrimpon@buffalo.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Ages: 8-12
Exclusion Criteria:
- Regular mindfulness or meditation practice (at least once/week)
- Participation in formal meditation or mindfulness interventions within the past year
- Suicidal ideation, self-injurious behaviour, or homicidal ideation
- Active psychosis symptoms
- Hospitalization within the past 6 months for psychiatric or medical conditions
- Diagnosis of seizure disorder or other neurological disorders
- History of thyroid or cardiovascular diseases
- Current substance use disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: In-person with recorded music
Participants are guided through in-person meditation twice a week, for 8 weeks.
These sessions will last approximately 1 hour and include guided meditation and completion of self-reported psychometric assessments.
Participants will also have access to virtual music-backed guided meditations to listen to between in-person sessions.
|
In-person guided meditation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Score Attentional Control Scale for Children
Time Frame: 8 weeks
|
The Attentional Control Scale for Children (ACS-C) is a validated, self-reported questionnaire.
It contains 20-items to assess attentional control abilities.
Scores are rated on a 4-point Likert scale.
Total scores range from 20 to 80, with higher scores indicating greater attentional control.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Score of Social Connectedness Scale
Time Frame: 8 weeks
|
The Social Connectedness Scale (SCS) is a validated, 20-item, self-reported questionnaire.
It assesses perceived social connectedness: the sense of being connected and part of a larger community or social group.
The scores are rated on a 6-point Likert scale.
The total score ranges from 20 to 120; the output reflects the level of social connectedness.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
March 11, 2026
First Submitted That Met QC Criteria
March 14, 2026
First Posted (Actual)
March 19, 2026
Study Record Updates
Last Update Posted (Actual)
May 15, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00009943
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data will be shared in aggregate through pre-prints, publications, and community stakeholders.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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