Community Galleries - Art and Children in Action: Protocol for a Cluster Non-Randomized Controlled Trial of an Art-Based Intervention to Promote Child Psychological Adjustment, Self-Concept and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 20
- 主要终点
- Change from baseline in the total difficulties as assessed by The Strengths and Difficulties Questionnaire.
研究概览
简要总结
The goal of this trial is to evaluate whether a community-based visual arts intervention can improve self-concept, psychological adjustment, and health-related quality of life (HRQoL) in children aged between 6 and 12, from socioeconomically disadvantaged neighborhoods.
The main questions it aims to answer are:
- Does the intervention improve children's psychological adjustment, as the primary outcome?
- Does the intervention improve self-concept and health-related quality of life (HRQoL) as the secondary outcomes?
- Is the intervention cost-effective compared to the waitlist control?
Researchers will compare children receiving the visual arts intervention (intervention group) with children not receiving the intervention (waiting list control group) to see if the program leads to measurable improvements in psychological adjustment, self-concept, and health-related quality of life.
Participants will:
- Take part in one-hour weekly visual arts sessions for nine months, led by professional artists;
- Participate in community art exhibitions at the end of the program;
- Complete questionnaires on psychological adjustment, self-concept, HRQoL, and societal resource use at baseline and post-intervention;
- Teachers/technicians will complete questionnaires on children's psychological adjustment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be enrolled in elementary school and registered as a participant or student in one of the 10 schools or institutions, partners of the Community Galleries project.
排除标准
- •Cognitive deficit, neurological disease or global developmental disorder
研究组 & 干预措施
Visual Art Intervention
The arts intervention will consist of two parts: (a) implementation of one-hour session of Visual Arts (e.g., painting, drawing, printing techniques exercises). (b) Children's final artistic products will be displayed in Community Galleries in their neighbourhood in an opening ceremony.
干预措施: Visual arts (Other)
Waitlist Control
结局指标
主要结局
Change from baseline in the total difficulties as assessed by The Strengths and Difficulties Questionnaire.
时间窗: Baseline and 9 months
The Strengths and Difficulties Questionnaire (SDQ) produces a total difficulties score ranging from 0 to 40, with higher scores indicating greater difficulties. It also comprises five subscales, each scored from 0 to 10: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Relationship Problems, and Prosocial Behaviour (for which higher scores indicate more prosocial behaviours).
次要结局
- Change from baseline of Self-concept as assed by The Self-Perception Profile for Children and the The Pictorial Scale of Perceived Competence and Social Acceptance for Young Children.(Baseline and 9 months)
- Quality-adjusted life years (QALY) gains from baseline as assed by the Child Health Utility 9 Dimensions.(Baseline and 9 months.)