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Enrolling by Invitation

NCT Number: NCT05755178

Musical 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.

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Key information

Conditions

Domestic Violence Child Development Group Intervention Music Therapy Psychological Distress

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Research and Development, Region Kronoberg

Vaxjo, 35112, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

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

    Time frame: 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.

    Time frame: Up to 4 months

    Qualitative data from interviews with parents.

  4. 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.

Sponsors and collaborators

Lead sponsor

Kronoberg County Council

Other Gov

Collaborators

  • Kvinnojouren Blenda
  • Musik i Syd

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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