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Enrolling by Invitation

NCT Number: NCT07481968

Community-Based Music Mindfulness Intervention on 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

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Key information

Conditions

Mental Health Issue

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Translational Research Center

Buffalo, New York, 14203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditation

Behavioral

In-person guided meditation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

Evaluating a Community-Based Music Mindfulness Intervention on Psychological and Physiological Outcomes in Children

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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