Menu
Enrolling by invitation NCT07481968

Community-Based Music Mindfulness Intervention on Children

No phase Interventional Mental Health Issue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Meditation.
Who it may be relevant to
Registry conditions: Mental Health Issue. Basic parameters: 8 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Behavioral Meditation
    In-person guided meditation

Primary outcome measures

  • Mean Score Attentional Control Scale for Children [Time frame: 8 weeks]
Secondary outcome measures (1)
  • Mean Score of Social Connectedness Scale [Time frame: 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Clinical Translational Research Center — Buffalo

Identifiers

NCT: NCT07481968 · STUDY00009943

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗