NCT03219190

Brief Summary

This project will develop and evaluate a program to prevent prescription drug misuse in high school students

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,804

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

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

First Submitted

Initial submission to the registry

July 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
4.5 years until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

July 13, 2017

Results QC Date

January 28, 2026

Last Update Submit

February 18, 2026

Conditions

Keywords

AdolescencePrescription Drug MisusePreventionHybridE-learningCigarette SmokingAlcohol UseLife Skills

Outcome Measures

Primary Outcomes (1)

  • Prescription Drug Misuse (i.e., Prescription Drug Use Without a Doctor's Prescription)

    This measure includes prescription drug misuse of sedatives, painkillers, and stimulants. Frequency of sedative, painkiller, and stimulant use without a doctor's prescription; measured on a 9-point scale, including Never (1), A few times but NOT in the past year (2), A few times a year (3), Once a month (4), A few times a month (5), Once a week (6), A few times a week (7), Once a day (8), More than once a day (9); Unabbreviated scale title: Prescription Drug Misuse (i.e., prescription drug use without a doctor's prescription); Minimum value = 1; maximum value = 9; Higher scores are a worse outcome

    Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

Secondary Outcomes (7)

  • Alcohol Use

    Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

  • Tobacco Use

    Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

  • Marijuana Use

    Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

  • Inhalant Use

    Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

  • Substance Use Intentions

    Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

  • +2 more secondary outcomes

Study Arms (2)

LST High School Hybrid

EXPERIMENTAL

Provided with the prevention program, consisting of e-learning modules and classroom sessions.

Behavioral: LST High School Hybrid

Treatment as Usual (Control)

NO INTERVENTION

Standard health education normally provided by the school

Interventions

The preventive intervention for high school PDM will: (1) utilize both online e-learning modules and interactive classroom sessions to address PDM and concurrent alcohol/drug abuse; (2) positively change social norms surrounding PDM and alcohol/drug abuse; (3) change positive expectancies about the benefits of PDM; (4) discourage diversion of prescription medication; (5) enhance protective factors by building social, self-regulation, and relationship skills through interactive learning and behavioral rehearsal scenarios; and (6) include online booster sessions.

LST High School Hybrid

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • High school aged-youth

You may not qualify if:

  • All students in the classroom were eligible to participate in the intervention. However, at the discretion of local school staff, students with significant cognitive impairment or severe learning disabilities were excused from completing the study questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Health Promotion Associates, Inc.

White Plains, New York, 10604, United States

Location

Related Publications (1)

  • Retraction of "Preventing tobacco and alcohol use among high school students through a hybrid online and in-class intervention: A randomized controlled trial," by Williams et al. (2025). Psychol Addict Behav. 2026 Feb;40(1):125. doi: 10.1037/adb0001131.

MeSH Terms

Conditions

Substance-Related DisordersPrescription Drug MisuseCigarette SmokingAlcohol Drinking

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersDrug MisuseTobacco SmokingSmokingBehaviorTobacco UseDrinking Behavior

Results Point of Contact

Title
Christopher Williams
Organization
National Health Promotion Associates, Inc

Study Officials

  • Christopher Williams, PhD, MPH

    National Health Promotion Associates, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

July 13, 2017

First Posted

July 17, 2017

Study Start

February 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

March 10, 2026

Results First Posted

March 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations