- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05755178
Musical Group Intervention for Children in Shelters
Music, Feelings and Relationships - Implementation and Evaluation of a Group Intervention for Children in Shelters
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Växjö, Sweden, 35112
- Department of Research and Development, Region Kronoberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 3-10 years
- Currently living or have lived at shelter together with a caregiver
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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