Overview

This trial is active, not recruiting.

Condition child development
Treatments treatment (invited entry 2012), control (invited entry 2013)
Sponsor Inter-American Development Bank
Start date February 2012
End date November 2015
Trial size 2914 participants
Trial identifier NCT02369315, IDB-2014-VE-1

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Children offered entry to music program in September 2012
treatment (invited entry 2012)
Entry to music program offered in September 2012
(Experimental)
Children offered entry to music program delayed until September 2013
control (invited entry 2013)
Entry to music program offered in September 2013

Primary Outcomes

Measure
Child self-regulatory skills
time frame: 1 year (baseline 2012 to followup 2013)
Child Behaviors
time frame: 1 year (baseline 2012-followup 2013)
Child Prosocial Skills and Connections
time frame: 1 year
Child Cognitive Skills
time frame: 1 year (baseline 2012-followup 2013)

Secondary Outcomes

Measure
Guardian Collective Efficacy
time frame: 1 year (baseline 2012-followup 2013)

Eligibility Criteria

Male or female participants from 6 years up to 14 years old.

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.

Additional Information

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)
Principal investigator Suzanne Duryea, Ph.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Inter-American Development Bank.