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

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ClinicalTrials.gov Identifier: NCT02369315
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Inter-American Development Bank

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

Condition or disease Intervention/treatment Phase
Child Development Behavioral: Treatment (Invited entry 2012) Behavioral: Control (Invited entry 2013) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2914 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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)
Study Start Date : February 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Guardian Collective Efficacy [ Time Frame: 1 year (baseline 2012-followup 2013) ]
    collective efficacy scale of Sampson et. al. 1997


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369315


Sponsors and Collaborators
Inter-American Development Bank
Investigators
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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
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Inter-American Development Bank
ClinicalTrials.gov Identifier: NCT02369315    
Other Study ID Numbers: IDB-2014-VE-1
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Inter-American Development Bank:
child development
music training
self-regulation
exposure to violence