Musical Group Intervention for Children in Shelters

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05755178
• Other study ID #: MGSB
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Kronoberg County Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Additionally, outcomes concerning emotional reactivity, capacity for emotional regulation, quality of life, and psychological health will be evaluated.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 96
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

• Age 3-10 years

• Currently living or have lived at shelter together with a caregiver

Related Conditions & MeSH terms

• Child Development
• Domestic Violence
• Music Therapy
• Psychological Distress

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Research and Development, Region Kronoberg	Växjö

Sponsors (3)

Lead Sponsor	Collaborator
Kronoberg County Council	Kvinnojouren Blenda, Musik i Syd

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of the intervention Music group for children at shelters.	Log after each session on participation and adaptions made.	Up to 4 months
Other	Childrens' experiences of participating in Music group for children at shelters.	Qualitative data from interviews with children.	Up to 4 months
Other	Parents' experiences of having a child participating in Music group for children at shelters.	Qualitative data from interviews with parents.	Up to 4 months
Other	Professionals' experiences of participating in Music group for children at shelters.	Qualitative data from interviews with professionals taking part in the intervention.	through study completion, an average of 2 years
Primary	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.	Up to 4 months
Primary	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.	Up to 4 months
Primary	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.	Up to 4 months
Secondary	Evaluation form Music group for children at shelters - child version	Scores and free text answers on satisfaction and experiences of participating in the intervention.	Up to 4 months
Secondary	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.	Up to 4 months
Secondary	Evaluation form Music group for children at shelters - professional version	Scores and free text answers on satisfaction and experiences of participating in the intervention.	Up to 4 months