Musical Group Intervention for Children in Shelters

October 9, 2023 updated by: Kronoberg County Council

Music, Feelings and Relationships - Implementation and Evaluation of a Group Intervention for Children in Shelters

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.

Study Overview

Detailed Description

Research problem and specific questions The project uses a mixed methods design in a naturalistic setting. Qualitative data concerning how children, caregivers and professionals experience the intervention and quantitative data concerning practical feasibility, adaptions made, and children's reported psychological health and quality of life will be studied. Data will be collected through questionnaires, log-forms, evaluation forms, and interviews with children, parents, and professionals. Thematic analysis and Interpretative phenomenological analysis will be used for qualitative data. Descriptive statistics and non-parametric methods will be used as applicable for quantitative data.

Plan for project realization The music group intervention will be offered to children 3-10 years, who live or have lived at a shelter. In all 12 groups with 4-8 children in each (48-96 children) will be realized. Collaboration with 2-3 shelters is established.

Questionnaires designed to measure psychological health, health-related quality of life, emotion reactivity, and capacity for emotional regulation will be administrated to caregivers pre- and post-intervention. A log-form will be filled out by professionals after each group session. Evaluation forms will be administrated to children, caregivers, and professionals after completing the intervention. Qualitative interviews focusing on feasibility, acceptance, and experiences of the intervention will be carried through with children, caregivers and professionals post intervention.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Växjö, Sweden, 35112
        • Department of Research and Development, Region Kronoberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Musical group intervention

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline on Strengths and Difficulties Questionnaire - Parent version at termination of intervention.
Time Frame: Up to 4 months
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.
Time Frame: Up to 4 months
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.
Time Frame: Up to 4 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation form Music group for children at shelters - child version
Time Frame: Up to 4 months
Scores and free text answers on satisfaction and experiences of participating in the intervention.
Up to 4 months
Evaluation form Music group for children at shelters - parent version
Time Frame: Up to 4 months
Scores and free text answers on parental satisfaction and experiences after havein a child participating in the intervention.
Up to 4 months
Evaluation form Music group for children at shelters - professional version
Time Frame: Up to 4 months
Scores and free text answers on satisfaction and experiences of participating in the intervention.
Up to 4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the intervention Music group for children at shelters.
Time Frame: Up to 4 months
Log after each session on participation and adaptions made.
Up to 4 months
Childrens' experiences of participating in Music group for children at shelters.
Time Frame: Up to 4 months
Qualitative data from interviews with children.
Up to 4 months
Parents' experiences of having a child participating in Music group for children at shelters.
Time Frame: Up to 4 months
Qualitative data from interviews with parents.
Up to 4 months
Professionals' experiences of participating in Music group for children at shelters.
Time Frame: through study completion, an average of 2 years
Qualitative data from interviews with professionals taking part in the intervention.
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 12, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • MGSB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychological Distress

Clinical Trials on Music, feelings and relationships - music group for children at shelters

3
Subscribe