A High School Program for Preventing Prescription Drug Misuse

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

Study Overview

• Status: Completed
• Conditions: Prescription Drug Abuse; Substance Abuse; Substance Use (Drugs, Alcohol)
• Intervention / Treatment: Behavioral: LST High School Hybrid

Detailed Description

This Fast-Track SBIR project is designed to address the critical need for an effective primary prevention approach for prescription misuse (PDM), an urgent public health crisis in the United States. The project involves developing and testing an innovative new approach to the primary prevention of PDM among high school students utilizing e-learning and small group facilitator-led intervention modalities. The intervention is an adaptation of the evidence-based substance abuse prevention approach called Life Skills Training (LST). The adapted intervention will address the relationship between PDM and alcohol, tobacco and other drug (ATOD) use and abuse; positively change social norms surrounding ATOD and PDM; discourage diversion of prescription medications; enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios.

Administrative Correction: This record was updated post-study to rectify administrative errors in the original registration and to reflect operational changes necessitated by the COVID-19 pandemic.

Correction of Secondary Outcomes: The Secondary Outcomes section has been corrected to include variables that were specified in several sections of the original registration and collected during the trial, but were inadvertently omitted from the "Outcome Measures" field in the initial registration. These include: alcohol use, tobacco use, marijuana use, inhalant use, perceived risk of prescription sedative, painkiller, and stimulant misuse, and life skills (self-regulation, communication, media resistance, anxiety management, refusal skills).

Update on Study Duration and Follow-up: The COVID-19 pandemic caused significant delays in study implementation and data collection. Although the original protocol specified 12- and 24-month follow-ups, the 24-month assessment was canceled because the study delays extended the timeline beyond the NIH/NIDA performance period. Additionally, widespread school closures and access restrictions resulted in high attrition at the 12-month time point, rendering those data insufficient for meaningful analysis. Consequently, the study analysis focuses exclusively on the immediate post-intervention timeframe.

Clarification on Terminology: Although our original grant application and ClinicalTrials.gov registration used the term Prescription Drug Abuse (PDA), we have adopted the more contemporary term Prescription Drug Misuse (PDM) to align with current best practices. PDM is defined here as the use of prescription drugs without a doctor's prescription.

• Study Type: Interventional
• Enrollment (Actual): 1804
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10604
      • National Health Promotion Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Correction of Minimum and Maximum Ages: The correct minimum and maximum age range for the study population is ages 14-18.

Inclusion Criteria:

• High school aged-youth

Exclusion Criteria:

• 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.

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: LST High School Hybrid; Provided with the prevention program, consisting of e-learning modules and classroom sessions.	Behavioral: LST High School Hybrid; 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.
No Intervention: Treatment as Usual (Control); Standard health education normally provided by the school

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use	This measure includes alcohol use and alcohol intoxication. Frequency of alcohol use and alcohol intoxication; 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: Alcohol Use; 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
Tobacco Use	This measure includes tobacco use. Frequency of cigarette/tobacco use; 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: Tobacco Use; 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
Marijuana Use	This measure includes marijuana use. Frequency of marijuana use; 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: Marijuana Use; 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
Inhalant Use	This measure includes inhalant use; 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: Inhalant Use; 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
Substance Use Intentions	This measure includes intentions to use substances: Intentions to use alcohol, get drunk, use tobacco, marijuana, and inhalants within the next year; measured on a 5-point scale from "Definitely Not" to "Definitely Will"; Unabbreviated scale title: Substance Use Intentions; Minimum value = 1; maximum value = 5; Higher scores are a worse outcome	Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported
Perceived Risk of Prescription Drug Misuse	This measure includes perceived risk of harm associated with using prescription sedatives, painkillers, and stimulants when prescribed for someone else, measured on a 4-point scale from "No Risk" to "Great Risk;" also option for "Can't say, drug unfamiliar"; Unabbreviated scale title: Perceived Risk of Prescription Drug Misuse; Minimum value = 1; maximum value = 4; Higher scores are a better outcome	Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported
Life Skills	Self-regulation skills: the ability to control one's thoughts, feelings, and behaviors; Communication skills: the ability to communicate effectively; Media resistance skills: the ability to resist messages from the media; Anxiety management skills: the ability to recognize and manage physical manifestations of anxiety; Refusal skills: the ability to resist pressure to use substances; All response options on a 5-point scale from "Strongly Disagree" to "Strongly Agree; except Communication skills, with response options on a 5-point scale from "Never" to "Always"; Unabbreviated scale title: Life Skills; Minimum value = 1; maximum value = 5; Higher scores are a better outcome	Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported

Collaborators and Investigators

• Sponsor: National Health Promotion Associates, Inc.
• Investigators: Principal Investigator: Christopher Williams, PhD, MPH, National Health Promotion Associates, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Prevention; Adolescence; Alcohol Use; Hybrid; Cigarette Smoking; E-learning; Prescription Drug Misuse; Life Skills
• Additional Relevant MeSH Terms: Drug Misuse; Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Behavior; Smoking; Tobacco Smoking; Tobacco Use; Alcohol Drinking; Substance-Related Disorders; Cigarette Smoking; Prescription Drug Misuse
• Other Study ID Numbers: 1R44DA04327301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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