NCT05755178

Brief Summary

The aim of the study is to augment knowledge on interventions for children who live, or have lived, in shelters after exposure to domestic violence. Research questions concern the feasibility of a music group intervention for children. The experiences of children, caregivers, and professionals will be investigated. Additionally, outcomes concerning emotional reactivity, capacity for emotional regulation, quality of life, and psychological health will be evaluated.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress83%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

February 12, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

2.3 years

First QC Date

February 12, 2023

Last Update Submit

October 8, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change from baseline on Strengths and Difficulties Questionnaire - Parent version at termination of intervention.

    Caregiver report of child psychopathology. Minimum score 0, maximum score 40, higher score indicating worse outcome.

    Up to 4 months

  • Change from baseline on Child Healthy Utility 9D at termination of intervention.

    Caregiver report of child health related quality of life. Minimum score 0, maximum score 36, higher score indicating worse outcome.

    Up to 4 months

  • Change from baseline on Emotion Questionnaire for parents at termination of intervention.

    Caregiver report of child health related quality of life. Minimum score 0, maximum score 36135, higher score indicating worse outcome.

    Up to 4 months

Secondary Outcomes (3)

  • Evaluation form Music group for children at shelters - child version

    Up to 4 months

  • Evaluation form Music group for children at shelters - parent version

    Up to 4 months

  • Evaluation form Music group for children at shelters - professional version

    Up to 4 months

Other Outcomes (4)

  • Feasibility of the intervention Music group for children at shelters.

    Up to 4 months

  • Childrens' experiences of participating in Music group for children at shelters.

    Up to 4 months

  • Parents' experiences of having a child participating in Music group for children at shelters.

    Up to 4 months

  • +1 more other outcomes

Study Arms (1)

Musical group intervention

EXPERIMENTAL

A music group intervention, offered to children 3-10 years who live or have lived at a shelter. 6 group sessions with musicians and music therapist and a group of 4-8 children. Focus on improving recognition and regulation of emotions, and on relational capacity with adults and peers.

Behavioral: Music, feelings and relationships - music group for children at shelters

Interventions

A music group intervention, offered to children 3-10 years who live or have lived at a shelter. 6 group sessions with musicians and music therapist and a group of 4-8 children. Focus on improving recognition and regulation of emotions, and on relational capacity with adults and peers.

Musical group intervention

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 3-10 years
  • Currently living or have lived at shelter together with a caregiver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Research and Development, Region Kronoberg

Vaxjo, 35112, Sweden

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2023

First Posted

March 6, 2023

Study Start

March 1, 2023

Primary Completion

June 30, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations