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

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)

This study evaluates Venezuela's National System of Child and Youth Orchestras, better known as "El Sistema".

Study Overview

• Status: Completed
• Conditions: Child Development
• Intervention / Treatment: Behavioral: Treatment (Invited entry 2012); Behavioral: Control (Invited entry 2013)

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).

• Study Type: Interventional
• Enrollment (Actual): 2914
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (Invited entry 2012); Children offered entry to music program in September 2012	Behavioral: Treatment (Invited entry 2012); Entry to music program offered in September 2012
Experimental: Control (Invited entry 2013); Children offered entry to music program delayed until September 2013	Behavioral: Control (Invited entry 2013); Entry to music program offered in September 2013

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)

Collaborators and Investigators

• Sponsor: Inter-American Development Bank
• Investigators: Principal Investigator: Suzanne Duryea, Ph.D., Inter-American Development Bank; Principal Investigator: Patrick McEwan, Ph.D., Wellesley College; Principal Investigator: Nancy Guerra, Ph.D., University of Delaware; Principal Investigator: Marco Stampini, Ph.D., Inter-American Development Bank

Publications and helpful links

General Publications

• Aleman X, Duryea S, Guerra NG, McEwan PJ, Munoz R, Stampini M, Williamson AA. The Effects of Musical Training on Child Development: a Randomized Trial of El Sistema in Venezuela. Prev Sci. 2017 Oct;18(7):865-878. doi: 10.1007/s11121-016-0727-3.

Helpful Links

• The Effects of Musical Training on Child Development: a Randomized Trial of El Sistema in Venezuela

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: February 16, 2015
• First Posted (Estimate): February 23, 2015

Study Record Updates

• Last Update Posted (Estimate): December 8, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: self-regulation; child development; exposure to violence; music training
• Other Study ID Numbers: IDB-2014-VE-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO