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Completed

NCT Number: NCT02369315

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

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

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Key information

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment (Invited entry 2012)

Behavioral

Entry to music program offered in September 2012

Control (Invited entry 2013)

Behavioral

Entry to music program offered in September 2013

Primary outcomes

  1. Child self-regulatory skills

    Time frame: 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)

  2. Child Behaviors

    Time frame: 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)

  3. Child Prosocial Skills and Connections

    Time frame: 1 year

    child self-esteem (Rosenberg scale), empathy (Bryant scale), and school and family engagement (BERS-2 subscales)

  4. Child Cognitive Skills

    Time frame: 1 year (baseline 2012-followup 2013)

    working memory (digit recall), processing speed (symbol search), and visual-spatial reasoning (Raven)

Secondary outcomes

  1. Guardian Collective Efficacy

    Time frame: 1 year (baseline 2012-followup 2013)

    collective efficacy scale of Sampson et. al. 1997

Sponsors and collaborators

Lead sponsor

Inter-American Development Bank

Other

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 23, 2015
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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