Prescription Drug Abuse, Substance Abuse, Substance Use (Drugs, Alcohol)
Conditions
Keywords
Adolescence, Prescription Drug Misuse, Prevention, Hybrid, E-learning, Cigarette Smoking, Alcohol Use, Life Skills
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.
Interventions
BEHAVIORALLST 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.
Sponsors
National Health Promotion Associates, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
Yes
Inclusion 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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prescription Drug Misuse (i.e., Prescription Drug Use Without a Doctor's Prescription) | 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
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use | 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 |
| Tobacco Use | 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 |
| Marijuana Use | 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 |
| Inhalant Use | 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 |
| Substance Use Intentions | 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 |
| Perceived Risk of Prescription Drug Misuse | 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 |
| Life Skills | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristopher Williams, PhD, MPH
National Health Promotion Associates, Inc.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 15.2 years |
| Race/Ethnicity, Customized Hispanic/Latino | 48 Participants |
| Race/Ethnicity, Customized Non-White | 66 Participants |
| Race/Ethnicity, Customized White | 1005 Participants |
| Sex: Female, Male Female | 407 Participants |
| Sex: Female, Male Male | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 731 | 0 / 504 |
| other Total, other adverse events | 0 / 731 | 0 / 504 |
| serious Total, serious adverse events | 0 / 731 | 0 / 504 |
Outcome results
None listed