Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:35 AM
Study NCT ID:
NCT07481968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-Based Music Mindfulness Intervention on Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Score Attentional Control Scale for Children', 'timeFrame': '8 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mean Score of Social Connectedness Scale', 'timeFrame': '8 weeks', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meditation', 'Music', 'Mindfulness', 'Children'], 'conditions': ['Mental Health Issue']}, 'descriptionModule': {'briefSummary': "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:\n\n* How do participants' psychological states change from the start to the end of the intervention?\n* What physiological changes, including heart rate variability and sleep patterns, are observed after the intervention?\n* Is this study feasible and acceptable to the community?\n\nParticipants will:\n\n* Attend in-person sessions, bi-weekly for 8 weeks\n* Regularly complete psychometric assessments\n* Wear fitness trackers daily, including overnight, throughout the study period\n* Track self-guided intervention online\n* Participate in semi-structured interviews pre-/post-study"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages: 8-12\n\nExclusion Criteria:\n\n* Regular mindfulness or meditation practice (at least once/week)\n* Participation in formal meditation or mindfulness interventions within the past year\n* Suicidal ideation, self-injurious behaviour, or homicidal ideation\n* Active psychosis symptoms\n* Hospitalization within the past 6 months for psychiatric or medical conditions\n* Diagnosis of seizure disorder or other neurological disorders\n* History of thyroid or cardiovascular diseases\n* Current substance use disorders'}, 'identificationModule': {'nctId': 'NCT07481968', 'briefTitle': 'Community-Based Music Mindfulness Intervention on Children', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Evaluating a Community-Based Music Mindfulness Intervention on Psychological and Physiological Outcomes in Children', 'orgStudyIdInfo': {'id': 'STUDY00009943'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In-person with recorded music', 'description': '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.', 'interventionNames': ['Behavioral: Meditation']}], 'interventions': [{'name': 'Meditation', 'type': 'BEHAVIORAL', 'description': 'In-person guided meditation', 'armGroupLabels': ['In-person with recorded music']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Jamal B Williams, PhD', 'role': 'CONTACT', 'email': 'jbwillia@buffalo.edu', 'phone': '716-888-4875'}], 'facility': 'Clinical Translational Research Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Deborah Frimpong', 'role': 'CONTACT', 'email': 'dfrimpon@buffalo.edu', 'phone': '647-550-7008'}], 'facility': 'Delavan Grider Community Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'centralContacts': [{'name': 'Jamal B Williams, PhD', 'role': 'CONTACT', 'email': 'jbwillia@buffalo.edu', 'phone': '716-888-4875'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified data will be shared in aggregate through pre-prints, publications, and community stakeholders.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Jamal B. Williams', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}