Domestic ViolenceNCT05755178
Musical Group Intervention for Children in Shelters
A study testing Music, feelings and relationships - music group for children at shelters in people with Domestic Violence and Child Development, run by Kronoberg County Council at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Domestic Violence, Child Development, Psychological Distress
- What is being tested?
- Music, feelings and relationships - music group for children at shelters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2023to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-10 years
- Currently living or have lived at shelter together with a caregiver
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Research and Development, Region Kronoberg
Vaxjo, 35112
About this study
Official title: Music, Feelings and Relationships - Implementation and Evaluation of a 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.
Read the 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.
- Conditions
- Domestic Violence, Child Development, Psychological Distress, Music Therapy, Group Intervention
- Being tested
- Music, feelings and relationships - music group for children at shelters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music, feelings and relationships - music group for children at sheltersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Musical group intervention | Experimental | 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. Receives: Behavioral: Music, feelings and relationships - music group for children at shelters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on Strengths and Difficulties Questionnaire - Parent version at termination of intervention.
Caregiver report of child psychopathology. Minimum score 0, maximum score 40, higher score indicating worse outcome.
Measured: Up to 4 months
Change from baseline on Child Healthy Utility 9D at termination of intervention.
Caregiver report of child health related quality of life. Minimum score 0, maximum score 36, higher score indicating worse outcome.
Measured: Up to 4 months
Change from baseline on Emotion Questionnaire for parents at termination of intervention.
Caregiver report of child health related quality of life. Minimum score 0, maximum score 36135, higher score indicating worse outcome.
Measured: Up to 4 months
Secondary outcomes (3)
Evaluation form Music group for children at shelters - child version
Scores and free text answers on satisfaction and experiences of participating in the intervention.
Measured: Up to 4 months
Evaluation form Music group for children at shelters - parent version
Scores and free text answers on parental satisfaction and experiences after havein a child participating in the intervention.
Measured: Up to 4 months
Evaluation form Music group for children at shelters - professional version
Scores and free text answers on satisfaction and experiences of participating in the intervention.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Mar 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kronoberg County Council
- Sponsor type
- Other government
- Collaborators
- Musik i Syd, Kvinnojouren Blenda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755178
- Sponsor's protocol ID
- MGSB
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No