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Completed

NCT Number: NCT03219190

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

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Key information

Conditions

Prescription Drug Abuse Alcohol Drinking Behavior Chemically-Induced Disorders Cigarette Smoking Drinking Behavior Drug Misuse Mental Disorders Prescription Drug Misuse Smoking Substance Abuse Substance Use (Drugs, Alcohol) Substance-Related Disorders Tobacco Smoking Tobacco Use

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Health Promotion Associates, Inc.

White Plains, New York, 10604, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LST High School Hybrid

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.

Primary outcomes

  1. 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

  1. Alcohol Use

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

    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

  2. Tobacco Use

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

    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

  3. Marijuana Use

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

    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

  4. Inhalant Use

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

    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

  5. Substance Use Intentions

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

    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

  6. Perceived Risk of Prescription Drug Misuse

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

    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

  7. Life Skills

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

    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

Sponsors and collaborators

Lead sponsor

National Health Promotion Associates, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2017
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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