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

Child Development Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369315
• Other study ID #: IDB-2014-VE-1
• Status: Completed
• Phase: N/A
• First received: February 16, 2015
• Last updated: December 6, 2016
• Start date: February 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Inter-American Development Bank
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2914
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Development

Intervention

Behavioral:
• Treatment (Invited entry 2012)
Entry to music program offered in September 2012
• Control (Invited entry 2013)
Entry to music program offered in September 2013

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inter-American Development Bank

References & Publications (1)

Alemán X, Duryea S, Guerra NG, McEwan PJ, Muñoz R, Stampini M, Williamson AA. The Effects of Musical Training on Child Development: a Randomized Trial of El Sistema in Venezuela. Prev Sci. 2016 Nov 28. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	Child Prosocial Skills and Connections	child self-esteem (Rosenberg scale), empathy (Bryant scale), and school and family engagement (BERS-2 subscales)	1 year	No
Primary	Child Cognitive Skills	working memory (digit recall), processing speed (symbol search), and visual-spatial reasoning (Raven)	1 year (baseline 2012-followup 2013)	No
Secondary	Guardian Collective Efficacy	collective efficacy scale of Sampson et. al. 1997	1 year (baseline 2012-followup 2013)	No

External Links

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