Child DevelopmentNCT02369315
Randomized Trial of the Effects of Musical Training on Child Development in the Venezuela Orchestra Program (El Sistema)
A study testing Treatment (Invited entry 2012) in people with Child Development, run by Inter-American Development Bank.
Trial summary
This study evaluates Venezuela's National System of Child and Youth Orchestras, better known as "El Sistema". Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Child Development
- What is being tested?
- Treatment (Invited entry 2012)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,914 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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)
This study evaluates Venezuela's National System of Child and Youth Orchestras, better known as "El Sistema".
Read the 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).
- Conditions
- Child Development
- Being tested
- Treatment (Invited entry 2012), Control (Invited entry 2013)
- Keywords
- child development, music training, self-regulation, exposure to violence
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment (Invited entry 2012)Behavioural
Entry to music program offered in September 2012
Control (Invited entry 2013)Behavioural
Entry to music program offered in September 2013
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Invited entry 2012) | Experimental | Children offered entry to music program in September 2012 Receives: Behavioral: Treatment (Invited entry 2012) |
| Control (Invited entry 2013) | Experimental | Children offered entry to music program delayed until September 2013 Receives: Behavioral: Control (Invited entry 2013) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 1 year
Child Cognitive Skills
working memory (digit recall), processing speed (symbol search), and visual-spatial reasoning (Raven)
Measured: 1 year (baseline 2012-followup 2013)
Secondary outcomes (1)
Guardian Collective Efficacy
collective efficacy scale of Sampson et. al. 1997
Measured: 1 year (baseline 2012-followup 2013)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startFeb 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,914 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inter-American Development Bank
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Duryea, Ph.D., Principal investigator, Inter-American Development BankPatrick McEwan, Ph.D., Principal investigator, Wellesley CollegeNancy Guerra, Ph.D., Principal investigator, University of DelawareMarco Stampini, Ph.D., Principal investigator, Inter-American Development Bank
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369315
- Sponsor's protocol ID
- IDB-2014-VE-1
- Status last verified
- Dec 2016
- First submitted
- 16 Feb 2015
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27896644
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02369315
- Acronym / sponsor ID
- IDB-2014-VE-1
- Conditions
- Child Development
- Keywords
- child development, music training, self-regulation, exposure to violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,914 participants (actual)
- Lead sponsor
- Inter-American Development BankUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates Venezuela's National System of Child and Youth Orchestras, better known as "El Sistema".
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (Invited entry 2012) | Experimental | Behavioral: Treatment (Invited entry 2012)Children offered entry to music program in September 2012 |
| Control (Invited entry 2013) | Experimental | Behavioral: Control (Invited entry 2013)Children offered entry to music program delayed until September 2013 |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment (Invited entry 2012)Entry to music program offered in September 2012 | Behavioural | Treatment (Invited entry 2012) |
| Control (Invited entry 2013)Entry to music program offered in September 2013 | Behavioural | Control (Invited entry 2013) |
Primary outcome
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)
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)
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)
Child Cognitive Skills
Time frame: 1 year (baseline 2012-followup 2013)
working memory (digit recall), processing speed (symbol search), and visual-spatial reasoning (Raven)
1 secondary outcome
Guardian Collective Efficacy
Time frame: 1 year (baseline 2012-followup 2013)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Results publication: PubMed 27896644Aleman 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.
- The Effects of Musical Training on Child Development: a Randomized Trial of El Sistema in VenezuelaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Duryea, Ph.D. principal investigator
Inter-American Development Bank
Patrick McEwan, Ph.D. principal investigator
Wellesley College
Nancy Guerra, Ph.D. principal investigator
University of Delaware
Questions about this trial
What is this clinical trial studying?
A study testing Treatment (Invited entry 2012) in people with Child Development, run by Inter-American Development Bank.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child self-regulatory skills (time frame: 1 year (baseline 2012 to followup 2013)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02369315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.