NCT07481968

Brief 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. 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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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 Progress25%
Apr 2026Nov 2026

First Submitted

Initial submission to the registry

March 11, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 15, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

March 11, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

MeditationMusicMindfulnessChildren

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (1)

  • Mean Score of Social Connectedness Scale

    8 weeks

Study Arms (1)

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.

Behavioral: Meditation

Interventions

MeditationBEHAVIORAL

In-person guided meditation

In-person with recorded music

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ages: 8-12

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical Translational Research Center

Buffalo, New York, 14203, United States

Location

Delavan Grider Community Center

Buffalo, New York, 14215, United States

Location

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Jamal B Williams, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 19, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 15, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified data will be shared in aggregate through pre-prints, publications, and community stakeholders.

Locations