Clinical trial NCT05755178: Musical Group Intervention for Children in Shelters
Official title: Music, Feelings and Relationships - Implementation and Evaluation of a Group Intervention for Children in Shelters
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Domestic Violence
Child Development
Psychological Distress
Music Therapy
Group Intervention
Lead sponsor: Kronoberg County Council
Sponsor class: OTHER_GOV
Collaborators: name: Musik i Syd
name: Kvinnojouren Blenda
First posted: 2023-03-06
Enrollment: 96
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Change from baseline on Strengths and Difficulties Questionnaire - Parent version at termination of intervention.
timeFrame: Up to 4 months
measure: Change from baseline on Child Healthy Utility 9D at termination of intervention.
timeFrame: Up to 4 months
measure: Change from baseline on Emotion Questionnaire for parents at termination of intervention.
timeFrame: Up to 4 months
Secondary outcomes:
measure: Evaluation form Music group for children at shelters - child version
timeFrame: Up to 4 months
measure: Evaluation form Music group for children at shelters - parent version
timeFrame: Up to 4 months
measure: Evaluation form Music group for children at shelters - professional version
timeFrame: Up to 4 months
Other outcomes:
measure: Feasibility of the intervention Music group for children at shelters.
timeFrame: Up to 4 months
measure: Childrens' experiences of participating in Music group for children at shelters.
timeFrame: Up to 4 months
measure: Parents' experiences of having a child participating in Music group for children at shelters.
timeFrame: Up to 4 months
measure: Professionals' experiences of participating in Music group for children at shelters.
timeFrame: through study completion, an average of 2 years
Locations:
city: Växjö
country: Sweden
facility: Department of Research and Development, Region Kronoberg
Study officials:
References: