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Enrolling by invitation NCT05755178

Musical Group Intervention for Children in Shelters

No phase Interventional Domestic Violence Child Development Psychological Distress Music Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music, feelings and relationships - music group for children at shelters.
Who it may be relevant to
Registry conditions: Domestic Violence, Child Development, Psychological Distress, Music Therapy. Basic parameters: 3 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Change from baseline on Strengths and Difficulties Questionnaire - Parent version at termination of intervention. [Time frame: Up to 4 months]
  • Change from baseline on Child Healthy Utility 9D at termination of intervention. [Time frame: Up to 4 months]
  • Change from baseline on Emotion Questionnaire for parents at termination of intervention. [Time frame: Up to 4 months]
Secondary outcome measures (3)
  • Evaluation form Music group for children at shelters - child version [Time frame: Up to 4 months]
  • Evaluation form Music group for children at shelters - parent version [Time frame: Up to 4 months]
  • Evaluation form Music group for children at shelters - professional version [Time frame: Up to 4 months]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Department of Research and Development, Region Kronoberg — Vaxjo

Identifiers

NCT: NCT05755178 · MGSB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗