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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music, Feelings and Relationships - Implementation and Evaluation of a Group Intervention for Children in Shelters
- ClinicalTrials.gov ID
- NCT05755178
- Acronym / sponsor ID
- MGSB
- Conditions
- Domestic Violence, Child Development, Psychological Distress, Music Therapy, Group Intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Kronoberg County CouncilOther government
- Collaborators
- Musik i Syd, Kvinnojouren Blenda
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Musical group intervention | Experimental | Behavioral: Music, feelings and relationships - music group for children at sheltersA 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. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 3-10 years
- Currently living or have lived at shelter together with a caregiver
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music, feelings and relationships - music group for children at sheltersA 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. | Behavioural | Musical group intervention |
Primary outcome
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.
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on Strengths and Difficulties Questionnaire - Parent version at termination of intervention. (time frame: Up to 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.