Design of a Multi-site Cluster Randomized Trial to Study the Effects of Musical Training on Child Development in the National System of Child and Youth Orchestras in Venezuela (El Sistema)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,914
- 主要终点
- Child Prosocial Skills and Connections
研究概览
简要总结
This study evaluates Venezuela's National System of Child and Youth Orchestras, better known as "El Sistema".
详细描述
The randomized control trial was conducted in 16 music centers in Venezuela between May 2012 and November 2013, with a population of 6-14 year olds seeking entry to the program. During an application period (May-July 2012), 2,603 guardians (the experimental cluster) applied on behalf of 2,999 6-14 year olds. Approximately half of the guardians were randomly offered early admission in September 2012, with the rest offered admission in September 2013. Baseline and follow-up data were collected on outcomes which will be explored for full-group and specific sub-groups (children with less educated mothers, and boys or girls exposed to violence).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Excess demand in 5 geographic areas: 24 music centers across the 5 states were identified as the experimental sites based on the likelihood of having excess demand by families in the 2012-13 academic year.
- •Apply protocol: Experimental sites agreed to accept written applications from guardians between May 7 and July 8, 2012 (without informing guardians of admission decisions until after randomization). Directors consented to participate in the experiment and received training in the experimental protocol. Children were eligible to apply if they would be 6 to 14 years old on September 1,
- •Sites received applications from 2,603 guardians on behalf of 2,999 children.
排除标准
- •Music center level: Two sites were excluded because their directors declined to follow the experimental protocol, and six were excluded because of insufficient demand to carry out randomized experiment.
- •Child/guardian level: By prior agreement, each site director could award early admission to a small number of applicants (no more than 5% of positions). In eight sites, 85 children (of 74 guardians) were excluded from the study because they entered through these positions allotted to site directors. Children were also lost from study if parental consent and child assent not given.
研究组 & 干预措施
Treatment (Invited entry 2012)
Children offered entry to music program in September 2012
干预措施: Treatment (Invited entry 2012) (Behavioral)
Control (Invited entry 2013)
Children offered entry to music program delayed until September 2013
干预措施: Control (Invited entry 2013) (Behavioral)
结局指标
主要结局
Child Prosocial Skills and Connections
时间窗: 1 year
child self-esteem (Rosenberg scale), empathy (Bryant scale), and school and family engagement (BERS-2 subscales)
Child Behaviors
时间窗: 1 year (baseline 2012-followup 2013)
prosocial behavior (SDQ Strengths subscale), difficulties (SDQ Difficulties subscale), risk-taking (risky driving game), and aggression (aggressive behavior and propensity scales)
Child self-regulatory skills
时间窗: 1 year (baseline 2012 to followup 2013)
self-reported 10 item self-control scale; response inhibition (Go/no-go), attention functioning (Flanker), and planning skills (Tower of London)
Child Cognitive Skills
时间窗: 1 year (baseline 2012-followup 2013)
working memory (digit recall), processing speed (symbol search), and visual-spatial reasoning (Raven)
次要结局
- Guardian Collective Efficacy(1 year (baseline 2012-followup 2013))