Randomized Trial of the Effects of Musical Training on Child Development in the Venezuela Orchestra Program (El Sistema)

Study Overview
=================
Brief Summary
-----------------
This study evaluates Venezuela's National System of Child and Youth Orchestras, better known as El Sistema.

Detailed Description
-----------------
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).

Official Title
-----------------
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)

Conditions
-----------------
Child Development

Intervention / Treatment
-----------------
* Behavioral: Treatment (Invited entry 2012)
* Behavioral: Control (Invited entry 2013)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 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, 2012. Sites received applications from 2,603 guardians on behalf of 2,999 children. Exclusion criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (Invited entry 2012)<br>Children offered entry to music program in September 2012 | Behavioral: Treatment (Invited entry 2012)<br>* Entry to music program offered in September 2012<br>|
| Experimental: Control (Invited entry 2013)<br>Children offered entry to music program delayed until September 2013 | Behavioral: Control (Invited entry 2013)<br>* Entry to music program offered in September 2013<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child self-regulatory skills | self-reported 10 item self-control scale; response inhibition (Go/no-go), attention functioning (Flanker), and planning skills (Tower of London) | 1 year (baseline 2012 to followup 2013) | 
| Child Behaviors | prosocial behavior (SDQ Strengths subscale), difficulties (SDQ Difficulties subscale), risk-taking (risky driving game), and aggression (aggressive behavior and propensity scales) | 1 year (baseline 2012-followup 2013) | 
| Child Prosocial Skills and Connections | child self-esteem (Rosenberg scale), empathy (Bryant scale), and school and family engagement (BERS-2 subscales) | 1 year | 
| Child Cognitive Skills | working memory (digit recall), processing speed (symbol search), and visual-spatial reasoning (Raven) | 1 year (baseline 2012-followup 2013) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Guardian Collective Efficacy | collective efficacy scale of Sampson et. al. 1997 | 1 year (baseline 2012-followup 2013) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
child development, music training, self-regulation, exposure to violence