A High School Program for Preventing Prescription Drug Misuse

NCT ID: NCT03219190

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1804 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-07-01

Brief Summary

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

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.

Conditions

Prescription Drug Abuse; Substance Abuse; Substance Use (Drugs, Alcohol)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

LST High School Hybrid

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

Group Type: EXPERIMENTAL

LST High School Hybrid

Intervention Type: BEHAVIORAL

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.

Treatment as Usual (Control)

Standard health education

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• High school aged-youth

Exclusion Criteria

• Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Health Promotion Associates, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Christopher Williams

Senior Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Williams, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

National Health Promotion Associates, Inc.

Locations

National Health Promotion Associates, Inc.

White Plains, New York, United States

Countries

United States

Other Identifiers

1R44DA04327301

Identifier Type: -

Identifier Source: org_study_id