NCT07218055

Brief Summary

This study is again looking at the use of music and music therapy experiences in navigating depression. The researchers will provide 11 sessions of music therapy and half will be followed by recitals at the Third Street School Music Settlement where the kids enrolled in our study will observe and interact with the performers and discuss and reflect on anxiety and performance and how sharing personal creativity affects them intra and interpersonally.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable depression

Timeline
2mo left

Started Sep 2025

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Sep 2025Aug 2026

Study Start

First participant enrolled

September 8, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2026

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

11 months

First QC Date

October 15, 2025

Last Update Submit

October 15, 2025

Conditions

Keywords

Children's sadnessanxietyfragilitymusic experiences in child assessment

Outcome Measures

Primary Outcomes (1)

  • Conor-Davidson Resilience Scale

    The Conor-Davidson Resilience Scale 10-item (Conor \& Davidson, 2003, 2007) or CD-RISC10 is scale measuring the resilience of an individual. Each item is rated on a 5-point scale from 0 (not true at all) to 4 (True nearly all the time) with scoring from 0 to 40. The higher an individual scores, the greater their resilience. The lower an individual scores, the lower the individual's resilience.

    end of 6 months

Secondary Outcomes (1)

  • CDI2 or Children's Depression Inventory, Second Edition

    end of 6 months

Study Arms (2)

Music

EXPERIMENTAL

Will receive assessment of music and 11 music therapy sessions as well as pretesting and f/u testing

Other: Music therapy

Control

SHAM COMPARATOR

Will receive assessment of music pre-testing and follow up post testing

Other: Music therapy

Interventions

hourly weekly music therapy sessions

Also known as: Verbal procession concert activity
ControlMusic

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Must indicate depression -or symptoms thereof by parent in writing

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Union Square

New York, New York, 10003, United States

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Joanne V Loewy, D.A., LCAT, MT-BC

    Icahn School of Medicine at Mount Sinai

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Randomly assigned to treatment or control
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Ransom assignment to intervention or control across 6 month period-11 sessions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor/Director

Study Record Dates

First Submitted

October 15, 2025

First Posted

October 20, 2025

Study Start

September 8, 2025

Primary Completion (Estimated)

August 4, 2026

Study Completion (Estimated)

August 4, 2026

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 3 months and ending 5 years following article publication.
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to Shantelena.Mouzon@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included in the URL field below).
More information

Locations