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This project will develop and evaluate a program to prevent prescription drug misuse in high school students
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LST High School Hybrid | Experimental | Provided with the prevention program, consisting of e-learning modules and classroom sessions. |
|
| Treatment as Usual (Control) | No Intervention | Standard health education normally provided by the school |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Correction of Minimum and Maximum Ages: The correct minimum and maximum age range for the study population is ages 14-18.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Williams, PhD, MPH | National Health Promotion Associates, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Health Promotion Associates, Inc. | White Plains | New York | 10604 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41627337 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | LST High School Hybrid | Provided with the prevention program, consisting of e-learning modules and classroom sessions. 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. |
| FG001 | Treatment as Usual (Control) | Standard health education normally provided by the school |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | LST High School Hybrid | Provided with the prevention program, consisting of e-learning modules and classroom sessions. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | score on a scale | Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LST High School Hybrid | Provided with the prevention program, consisting of e-learning modules and classroom sessions. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Williams | National Health Promotion Associates, Inc | 914-421-2525 | cwilliams@nhpamail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2026 | Jan 28, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D063487 | Prescription Drug Misuse |
| D000073865 | Cigarette Smoking |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000076064 | Drug Misuse |
| D000073869 | Tobacco Smoking |
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|
| 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 |
| BG001 | Treatment as Usual (Control) | Standard health education normally provided by the school |
| BG002 | Total | Total of all reporting groups |
| Schools |
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| years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
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| OG001 | Treatment as Usual (Control) | Standard health education normally provided by the school |
|
|
| Secondary | 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 | Not Posted | Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported | Participants |
| Secondary | 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 | Not Posted | Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported | Participants |
| Secondary | 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 | Not Posted | Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported | Participants |
| Secondary | 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 | Not Posted | Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported | Participants |
| Secondary | 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 | Not Posted | Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported | Participants |
| Secondary | 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 | Posted | Mean | Standard Error | score on a scale | Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported |
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| Secondary | 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 | Not Posted | Assessed at pre-test and post-test assessment, post-test assessment approximately 2-4 weeks post-intervention reported | Participants |
| 0 |
| 731 |
| 0 |
| 731 |
| 0 |
| 731 |
| EG001 | Treatment as Usual (Control) | Standard health education normally provided by the school | 0 | 504 | 0 | 504 | 0 | 504 |
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| D012907 |
| Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D004327 | Drinking Behavior |
| Prescription stimulants, risk o harm |
|