Evaluation of Universal Prevention Curriculum for Schools in Peru

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.

Study Overview

• Status: Completed
• Conditions: Substance Use
• Intervention / Treatment: Other: Universal Prevention Curriculum Training for Schools

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 Type: Interventional
• Enrollment (Actual): 27012
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94704
      • Prevention Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Students in participating schools aged 11 to 19

Exclusion Criteria:

• Not attending participating schools

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Received UPC training, school policy and climate interventions, and Unplugged prevention program	Other: Universal Prevention Curriculum Training for Schools; School administrators and teachers participated in UPC training and formed prevention leadership action teams
No Intervention: Control; Only implemented Unplugged prevention program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarette smoking	Smoking cigarettes	1 year
Alcohol use	Drinking alcoholic beverages	1 year
Heavy drinking	Five or more consecutive alcoholic drinks	1 year
Marijuana use	Marijuana use	1 year
Other drug use	Use of inhalants, cocaine, PCB, hallucinogens	1 year
Problems	Problems related to substance use	1 year
Friends' substance use	Friends' use of tobacco, alcohol, marijuana and other drugs	1 year
Awareness of school policies	Awareness of school tobacco and alcohol policies	1 year
School bonding	School bonding	1 year

Collaborators and Investigators

• Sponsor: HBSA
• Investigators: Principal Investigator: Mallie J Paschall, PhD, HBSA

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: Peru UPC Evaluation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified participant data will be available to other researchers upon request after completion of the current study in December 2022.
• IPD Sharing Time Frame: Data will become available after completion of the current study in December 2022, and will be available for five years afterwards.
• IPD Sharing Access Criteria: Data access information will be provided by the Principal Investigator.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No