A High School Program for Preventing Prescription Drug Misuse

National Health Promotion Associates

Status: Completed

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

Treatments: Behavioral: LST High School Hybrid

Study type: Interventional

Funder types: Industry

Identifiers

NCT03219190

1R44DA04327301

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,804 patients

Sex: All

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,804 participants in 2 patient groups

LST High School Hybrid

Experimental group

Description:

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

Treatment:

Behavioral: LST High School Hybrid

Treatment as Usual (Control)

No Intervention group

Description:

Standard health education