NCT02369315

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,914

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

4.8 years

First QC Date

February 16, 2015

Last Update Submit

December 6, 2016

Conditions

Keywords

child developmentmusic trainingself-regulationexposure to violence

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Guardian Collective Efficacy

    1 year (baseline 2012-followup 2013)

Study Arms (2)

Treatment (Invited entry 2012)

EXPERIMENTAL

Children offered entry to music program in September 2012

Behavioral: Treatment (Invited entry 2012)

Control (Invited entry 2013)

EXPERIMENTAL

Children offered entry to music program delayed until September 2013

Behavioral: Control (Invited entry 2013)

Interventions

Entry to music program offered in September 2012

Treatment (Invited entry 2012)

Entry to music program offered in September 2013

Control (Invited entry 2013)

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Self-Control

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

February 23, 2015

Study Start

February 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 8, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share