Substance UseNCT04699526
Evaluation of Universal Prevention Curriculum for Schools in Peru
A study testing Universal Prevention Curriculum Training for Schools in people with Substance Use, run by HBSA at 1 site in United States.
Trial summary
This randomized controlled trial was conducted to evaluate a universal prevention curriculum (UPC) training for Peruvian school administrators and teachers to reduce substance use among students. Twenty-eight schools were randomly assigned to intervention and control conditions (14 per condition). Read more about this study
- Who is it for?
- Ages 11 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- Universal Prevention Curriculum Training for Schools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27,012 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 30 Nov 2019
- 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 11 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students in participating schools aged 11 to 19
Who cannot join
- Not attending participating schools
Trial locations and contacts
1 site in 1 country.
United States1 site
Prevention Research Center
Berkeley, California, 94704
About this study
This randomized controlled trial was conducted to evaluate a universal prevention curriculum (UPC) training for Peruvian school administrators and teachers to reduce substance use among students. Twenty-eight schools were randomly assigned to intervention and control conditions (14 per condition). Substance use outcomes were assessed with repeated cross-sectional samples of students in 2018 and 2019. Multi-level analyses were conducted to assess intervention effects on students' substance use and related problems.
Read the detailed description
This randomized controlled trial was conducted to evaluate a universal prevention curriculum (UPC) training for Peruvian school administrators and teachers to reduce substance use among students. Twenty-eight schools were randomly assigned to intervention and control conditions (14 per condition). Prevention leadership action teams were formed at intervention schools to implement evidence-based school policies and positive school climate activities, and a classroom substance use prevention curriculum. Substance use outcomes were assessed with repeated cross-sectional samples of students in 2018 and 2019. Multi-level analyses were conducted to assess intervention effects on students' substance use and related problems.
- Conditions
- Substance Use
- Being tested
- Universal Prevention Curriculum Training for Schools
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal Prevention Curriculum Training for SchoolsOther
School administrators and teachers participated in UPC training and formed prevention leadership action teams
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Received UPC training, school policy and climate interventions, and Unplugged prevention program Receives: Other: Universal Prevention Curriculum Training for Schools |
| Control | No intervention | Only implemented Unplugged prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette smoking
Smoking cigarettes
Measured: 1 year
Alcohol use
Drinking alcoholic beverages
Measured: 1 year
Heavy drinking
Five or more consecutive alcoholic drinks
Measured: 1 year
Marijuana use
Marijuana use
Measured: 1 year
Other drug use
Use of inhalants, cocaine, PCB, hallucinogens
Measured: 1 year
Problems
Problems related to substance use
Measured: 1 year
Friends' substance use
Friends' use of tobacco, alcohol, marijuana and other drugs
Measured: 1 year
Awareness of school policies
Awareness of school tobacco and alcohol policies
Measured: 1 year
School bonding
School bonding
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 May 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- HBSA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mallie J. Paschall, Ph.D., HBSA
- Investigators
- Mallie J Paschall, PhD, Principal investigator, HBSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699526
- Sponsor's protocol ID
- Peru UPC Evaluation
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be available to other researchers upon request after completion of the current study in December 2022.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Universal Prevention Curriculum for Schools in Peru
- ClinicalTrials.gov ID
- NCT04699526
- Acronym / sponsor ID
- Peru UPC Evaluation
- Conditions
- Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27,012 participants (actual)
- Lead sponsor
- HBSAUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 7 Jan 2021 (actual)
- 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 randomized controlled trial was conducted to evaluate a universal prevention curriculum (UPC) training for Peruvian school administrators and teachers to reduce substance use among students. Twenty-eight schools were randomly assigned to intervention and control conditions (14 per condition). Substance use outcomes were assessed with repeated cross-sectional samples of students in 2018 and 2019. Multi-level analyses were conducted to assess intervention effects on students' substance use and related problems.
Detailed description
This randomized controlled trial was conducted to evaluate a universal prevention curriculum (UPC) training for Peruvian school administrators and teachers to reduce substance use among students. Twenty-eight schools were randomly assigned to intervention and control conditions (14 per condition). Prevention leadership action teams were formed at intervention schools to implement evidence-based school policies and positive school climate activities, and a classroom substance use prevention curriculum. Substance use outcomes were assessed with repeated cross-sectional samples of students in 2018 and 2019. Multi-level analyses were conducted to assess intervention effects on students' substance use and related problems.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Universal Prevention Curriculum Training for SchoolsReceived UPC training, school policy and climate interventions, and Unplugged prevention program |
| Control | No intervention | –Only implemented Unplugged prevention program |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Students in participating schools aged 11 to 19
Key exclusion criteria (1 listed)
- Not attending participating schools
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 |
|---|---|---|
| Universal Prevention Curriculum Training for SchoolsSchool administrators and teachers participated in UPC training and formed prevention leadership action teams | Other | Intervention |
Primary outcome
Cigarette smoking
Time frame: 1 year
Smoking cigarettes
Alcohol use
Time frame: 1 year
Drinking alcoholic beverages
Heavy drinking
Time frame: 1 year
Five or more consecutive alcoholic drinks
Marijuana use
Time frame: 1 year
Marijuana use
Other drug use
Time frame: 1 year
Use of inhalants, cocaine, PCB, hallucinogens
Problems
Time frame: 1 year
Problems related to substance use
Friends' substance use
Time frame: 1 year
Friends' use of tobacco, alcohol, marijuana and other drugs
Awareness of school policies
Time frame: 1 year
Awareness of school tobacco and alcohol policies
School bonding
Time frame: 1 year
School bonding
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 7 Jan 2021.
- Individual participant dataSharing planned: Yes. De-identified participant data will be available to other researchers upon request after completion of the current study in December 2022.
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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.
Mallie J Paschall, PhD principal investigator
HBSA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Universal Prevention Curriculum Training for Schools in people with Substance Use, run by HBSA at 1 site in United States.
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 1 inclusion and 1 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 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cigarette smoking (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2021.