Musical Group Intervention for Children in Shelters

Sponsor
Kronoberg County Council (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05755178
Collaborator
Musik i Syd (Other), Kvinnojouren Blenda (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music, feelings and relationships - music group for children at shelters
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Music, Feelings and Relationships - Implementation and Evaluation of a Group Intervention for Children in Shelters
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline on Strengths and Difficulties Questionnaire - Parent version at termination of intervention. [Up to 4 months]

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

  2. Change from baseline on Child Healthy Utility 9D at termination of intervention. [Up to 4 months]

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

  3. Change from baseline on Emotion Questionnaire for parents at termination of intervention. [Up to 4 months]

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

Secondary Outcome Measures

  1. Evaluation form Music group for children at shelters - child version [Up to 4 months]

    Scores and free text answers on satisfaction and experiences of participating in the intervention.

  2. Evaluation form Music group for children at shelters - parent version [Up to 4 months]

    Scores and free text answers on parental satisfaction and experiences after havein a child participating in the intervention.

  3. Evaluation form Music group for children at shelters - professional version [Up to 4 months]

    Scores and free text answers on satisfaction and experiences of participating in the intervention.

Other Outcome Measures

  1. Feasibility of the intervention Music group for children at shelters. [Up to 4 months]

    Log after each session on participation and adaptions made.

  2. Childrens' experiences of participating in Music group for children at shelters. [Up to 4 months]

    Qualitative data from interviews with children.

  3. Parents' experiences of having a child participating in Music group for children at shelters. [Up to 4 months]

    Qualitative data from interviews with parents.

  4. Professionals' experiences of participating in Music group for children at shelters. [through study completion, an average of 2 years]

    Qualitative data from interviews with professionals taking part in the intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age 3-10 years

  • Currently living or have lived at shelter together with a caregiver

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Research and Development, Region Kronoberg Växjö Sweden 35112

Sponsors and Collaborators

  • Kronoberg County Council
  • Musik i Syd
  • Kvinnojouren Blenda

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kronoberg County Council
ClinicalTrials.gov Identifier:
NCT05755178
Other Study ID Numbers:
  • MGSB
First Posted:
Mar 6, 2023
Last Update Posted:
Mar 6, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 6, 2023