Mental Health IssueNCT07481968
Community-Based Music Mindfulness Intervention on Children
A study testing Meditation in people with Mental Health Issue, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages: 8-12
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Translational Research Center
Buffalo, New York, 14203
About this study
Official title: 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?
Read more
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
- Conditions
- Mental Health Issue
- Being tested
- Meditation
- Keywords
- Meditation, Music, Mindfulness, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
In-person guided meditation
| Study group | Role | What they receive |
|---|---|---|
| In-person with recorded music | Experimental | 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. Receives: Behavioral: Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Score Attentional Control Scale for Children
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.
Measured: 8 weeks
Secondary outcomes (1)
Mean Score of Social Connectedness Scale
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start20 May 2026
- Primary completion20 Aug 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamal B. Williams, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481968
- Sponsor's protocol ID
- STUDY00009943
- Status last verified
- Jul 2026
- First submitted
- 11 Mar 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared in aggregate through pre-prints, publications, and community stakeholders.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Community-Based Music Mindfulness Intervention on Psychological and Physiological Outcomes in Children
- ClinicalTrials.gov ID
- NCT07481968
- Acronym / sponsor ID
- STUDY00009943
- Conditions
- Mental Health Issue
- Keywords
- Meditation, Music, Mindfulness, Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Mar 2026 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-person with recorded music | Experimental | Behavioral: MeditationParticipants 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Ages: 8-12
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| MeditationIn-person guided meditation | Behavioural | In-person with recorded music |
Primary outcome
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.
1 secondary outcome
Mean Score of Social Connectedness Scale
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared in aggregate through pre-prints, publications, and community stakeholders.
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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 Meditation in people with Mental Health Issue, run by State University of New York at Buffalo at 1 site in United States.
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 1 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mean Score Attentional Control Scale for Children (time frame: 8 weeks). 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 1 Oct 2026.