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Evaluation of Universal Prevention Curriculum for Schools in Peru

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Universal Prevention Curriculum Training for Schools
Sponsored by
HBSA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use

Eligibility Criteria

11 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Students in participating schools aged 11 to 19

Exclusion Criteria:

  • Not attending participating schools

Sites / Locations

  • Prevention Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

Only implemented Unplugged prevention program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 4, 2021
Last Updated
January 5, 2021
Sponsor
HBSA
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1. Study Identification

Unique Protocol Identification Number
NCT04699526
Brief Title
Evaluation of Universal Prevention Curriculum for Schools in Peru
Official Title
Evaluation of Universal Prevention Curriculum for Schools in Peru
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HBSA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27012 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Received UPC training, school policy and climate interventions, and Unplugged prevention program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Only implemented Unplugged prevention program
Intervention Type
Other
Intervention Name(s)
Universal Prevention Curriculum Training for Schools
Intervention Description
School administrators and teachers participated in UPC training and formed prevention leadership action teams
Primary Outcome Measure Information:
Title
Cigarette smoking
Description
Smoking cigarettes
Time Frame
1 year
Title
Alcohol use
Description
Drinking alcoholic beverages
Time Frame
1 year
Title
Heavy drinking
Description
Five or more consecutive alcoholic drinks
Time Frame
1 year
Title
Marijuana use
Description
Marijuana use
Time Frame
1 year
Title
Other drug use
Description
Use of inhalants, cocaine, PCB, hallucinogens
Time Frame
1 year
Title
Problems
Description
Problems related to substance use
Time Frame
1 year
Title
Friends' substance use
Description
Friends' use of tobacco, alcohol, marijuana and other drugs
Time Frame
1 year
Title
Awareness of school policies
Description
Awareness of school tobacco and alcohol policies
Time Frame
1 year
Title
School bonding
Description
School bonding
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Students in participating schools aged 11 to 19 Exclusion Criteria: Not attending participating schools
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mallie J Paschall, PhD
Organizational Affiliation
HBSA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prevention Research Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Evaluation of Universal Prevention Curriculum for Schools in Peru

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