NCT04699526

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27,012

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

1.6 years

First QC Date

January 4, 2021

Last Update Submit

January 5, 2021

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Universal Prevention Curriculum Training for Schools

Control

NO INTERVENTION

Only implemented Unplugged prevention program

Interventions

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

Intervention

Eligibility Criteria

Age11 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Students in participating schools aged 11 to 19

You may not qualify if:

  • Not attending participating schools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prevention Research Center

Berkeley, California, 94704, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Schools

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

  • Mallie J Paschall, PhD

    HBSA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 7, 2021

Study Start

May 1, 2018

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

January 7, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
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.

Locations