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Clinical Trials/NCT05755178
NCT05755178Active, not recruitingNot Applicable

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

Kronoberg County Council1 site in 1 country96 target enrollmentStarted: March 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
96
Locations
1
Primary Endpoint
Change from baseline on Strengths and Difficulties Questionnaire - Parent version at termination of intervention.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
3 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

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.

Intervention: Music, feelings and relationships - music group for children at shelters (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Evaluation form Music group for children at shelters - child version(Up to 4 months)
  • Evaluation form Music group for children at shelters - parent version(Up to 4 months)
  • Evaluation form Music group for children at shelters - professional version(Up to 4 months)

Investigators

Sponsor
Kronoberg County Council
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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