ClinicalTrials.gg
CompletedNCT04699526Updated Jan 7, 2021

Evaluation of Universal Prevention Curriculum for Schools in Peru

An interventional study of Universal Prevention Curriculum Training for Schools in Substance Use, sponsored by HBSA. Completed at 1 site in United States. Open to participants aged 11 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-07.

Sponsored by HBSA · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled May 2018, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
27,012
Allocation
Randomized
Ages
11 Years to 19 Years
Sex
All
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Study 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). 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.

02

Conditions studied

  • Substance Use
03

In context

Substance-Related Disorders

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

This study's enrollment of 27,012 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

HBSA is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Students in participating schools aged 11 to 19

Exclusion criteria

Exclusion Criteria:

  • Not attending participating schools
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27,012 participants (actual)

Study arms

  • Experimental
    Intervention

    Received UPC training, school policy and climate interventions, and Unplugged prevention program

    Other: Universal Prevention Curriculum Training for Schools

  • No intervention
    Control

    Only implemented Unplugged prevention program

Interventions

  • OtherUniversal Prevention Curriculum Training for Schools

    School administrators and teachers participated in UPC training and formed prevention leadership action teams

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What researchers measure

Primary outcomes

  1. Cigarette smoking

    Smoking cigarettes

    Time frame: 1 year

  2. Alcohol use

    Drinking alcoholic beverages

    Time frame: 1 year

  3. Heavy drinking

    Five or more consecutive alcoholic drinks

    Time frame: 1 year

  4. Marijuana use

    Marijuana use

    Time frame: 1 year

  5. Other drug use

    Use of inhalants, cocaine, PCB, hallucinogens

    Time frame: 1 year

  6. Problems

    Problems related to substance use

    Time frame: 1 year

  7. Friends' substance use

    Friends' use of tobacco, alcohol, marijuana and other drugs

    Time frame: 1 year

  8. Awareness of school policies

    Awareness of school tobacco and alcohol policies

    Time frame: 1 year

  9. School bonding

    School bonding

    Time frame: 1 year

07

Study locations

1 site
  • Prevention Research Center
    Berkeley, California 94704, United States
08

References and documents

Individual participant data

Plan to share: Yes — De-identified participant data will be available to other researchers upon request after completion of the current study in December 2022.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data will become available after completion of the current study in December 2022, and will be available for five years afterwards.

Access criteria: Data access information will be provided by the Principal Investigator.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04699526
Lead sponsor
HBSA
Responsible party
Mallie J. Paschall, Ph.D. (Senior Research Scientist, HBSA) — Principal investigator
First posted
Jan 7, 2021
Start date
May 1, 2018
Primary completion
Nov 30, 2019
Completion
Nov 30, 2019
Last update
Jan 7, 2021

Study contacts

Mallie J Paschall, PhD
principal investigator · HBSA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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