A High School Program for Preventing Prescription Drug Misuse
Overview
- Phase
- N/A
- Intervention
- LST High School Hybrid
- Conditions
- Not specified
- Sponsor
- National Health Promotion Associates, Inc.
- Enrollment
- 1804
- Locations
- 1
- Primary Endpoint
- Prescription Drug Misuse (i.e., Prescription Drug Use Without a Doctor's Prescription)
- Status
- Completed
- Last Updated
- last month
Overview
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.
Investigators
Christopher Williams
Senior Research Scientist
National Health Promotion Associates, Inc.
Eligibility Criteria
Inclusion Criteria
- •Correction of Minimum and Maximum Ages: The correct minimum and maximum age range for the study population is ages 14-
- •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.
Arms & Interventions
LST High School Hybrid
Provided with the prevention program, consisting of e-learning modules and classroom sessions.
Intervention: LST High School Hybrid
Treatment as Usual (Control)
Standard health education normally provided by the school
Outcomes
Primary Outcomes
Prescription Drug Misuse (i.e., Prescription Drug Use Without a Doctor's Prescription)
Time Frame: Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported
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
Secondary Outcomes
- Substance Use Intentions(Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported)
- Life Skills(Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported)
- 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)
- Perceived Risk of Prescription Drug Misuse(Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported)