Personalized Health Assessment Related to Medications (Project PHARM)

Study Overview
=================
Brief Summary
-----------------
This research will adapt an evidence based intervention for alcohol and other drugs and evaluate its efficacy on Prescription Stimulant Medication (PSM) misuse in a web-based format for use with college students who have misused PSMs.

Detailed Description
-----------------
This project proposes to evaluate the efficacy of Screening and Brief Interventions (SBIs) for reducing college students' PSM misuse through two different routes of screening and intervention across 9 colleges and universities spanning the United States. The research will consist of studies designed to 1) conduct focus groups to refine feedback materials (Study 1); 2) Conduct screening through the Registrar's student lists and implement a randomized controlled trial (RCT) of a web-based PSM intervention at all sites (Study 2); and 3) Evaluate the impact of the COVID-19 pandemic using the Study 2 sample on non-medical use of prescription stimulants, prescription opiates, alcohol use, marijuana use, and other substances during the COVID-19 pandemic, and understand motives, access, mental health impacts, and college student and young adult experiences during this unprecedented 12 months. Study 1 consists of conducting up to 5 focus groups of 8-12 people to elicit feedback regarding the Personalized Feedback Tool and make refinements prior to carrying out Study 2. In Study 2, students from 9 college campuses are screened for past year PSM misuse. Those meeting study criteria are invited to complete a web-based baseline survey and are randomized to either receive the web-based personalized feedback intervention (PFI) or to assessment only control. Participants complete follow-up assessments at 6 and 12 months post-baseline to evaluate intervention efficacy. The investigators hypothesize that participants who receive the PFI will reduce PSM misuse assessed at 6 and 12 month follow-ups. The investigators further expect reductions in perceived benefits of PSM and perceived descriptive norms for PSM, and increases in use of alternative behaviors to support academic success, and expect these changes will mediate impacts on PSM use at follow-ups. Secondary effects of the intervention on alcohol and marijuana use are also anticipated, and these reductions are expected to partially mediate PSM outcomes. Finally, PSM motives and demographics as potential moderators of intervention efficacy will also be explored. Lastly, in February of 2021, we received approval to modify the aims for Study 3 to evaluate the impact of the COVID-19 pandemic using the Study 2 sample. In an already consented, recruited, and well-characterized sample of high-risk young adults reporting poly-substance use (Study 2 participants, n=843), Study 3 aimed to describe changes in non-medical use of prescription stimulants, prescription opiates, alcohol use, marijuana use, and other substances during the COVID-19 pandemic, and understand motives, access, mental health impacts, and college student and young adult experiences during this unprecedented 12 months. Specifically, we intend to evaluate changes pre- and post-pandemic in non-medical use of PSM, non-medical use of prescription opioid medications (POM), alcohol use, and marijuana use, as well as mood utilizing Study 2 baseline and follow-up data, controlling for intervention condition and time since last assessment. We also will evaluate student status and living arrangement as moderators. The investigators hypothesize: (1) Young adults will report less PSM and less POM during the pandemic compared to pre-pandemic assessments, in part due to reduced ease of access and a change in motives for use; (2) Given previous findings that academic motives were 8 of the 9 most frequently endorsed reasons for PSM, and given perceptions that a move to virtual learning has been less academically challenging, we hypothesize that academic motives for PSM will decrease significantly during the pandemic compared to pre-pandemic; (3) Those no longer in school will report less PSM and less POM during the pandemic compared to pre-pandemic. (4) Those living at home will have decreased alcohol and marijuana use compared to pre-pandemic. Among those reporting current student status at the time of the new survey, we will be able to evaluate changes in motives for use, access, and academic pressure from baseline to present.

Official Title
-----------------
Personalized Health Assessment Related to Medications (Project PHARM)

Conditions
-----------------
Feedback, Psychological, Clinical Trial, Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: Web-based PFI
* Behavioral: Assessment Only


Participation Criteria
=================
Eligibility Criteria
-----------------
Study 1 Inclusion Criteria: Provides consent to participate Currently enrolled as a student at one of the participating campuses Between 18-25 year olds Misuse of prescription stimulants in the past year Study 1 Exclusion Criteria: There are no exclusion criteria other than not meeting inclusion criteria. Study 2 Inclusion Criteria: Provides consent to participate Currently enrolled as a student at one of the participating campuses and in their second semester/quarter or later Has an anticipated graduation date at least 12 months into the future Between 18-25 year olds Misuse of prescription stimulants in the past year Study 2 Exclusion Criteria: There are no exclusion criteria other than not meeting inclusion criteria. Study 3 Inclusion Criteria: Provides consent to participate Previous participation as a Study 2 participant. Study 3 Exclusion Criteria: There are no exclusion criteria other than not meeting inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-Based PFI<br>Participants randomized to the web-based PFI in Study 2 receive a 5 component Personalized Feedback Tool. The first component is presented immediately after the baseline survey and a link to each of the remaining 4 components is sent to participants spaced 1 to 2 weeks apart. The PFI components cover: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. Each component is comprised of personalized feedback presented in text and graphic format, and each component includes links to tips for making changes if and when the participant is contemplating or ready to commit to change. These tips include general relapse prevention strategies, as well as information about the importance of regular class attendance, study habits, and sleep habits for academic success. General educational tips/strategies for time management, as well as tips for initiating behavior change are also included. Each component takes approximately 5-10 minutes to review. | Behavioral: Web-based PFI<br>* A web-based 5 component Personalized Feedback Tool covering content on: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol.<br>|
| Other: Assessment Only<br>The Assessment Only group receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6-month follow-up, and 12-month follow-up in Study 2. | Behavioral: Assessment Only<br>* The Assessment Only condition receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6 month follow-up, and 12 month follow-up.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency | Assesses frequency of non-medical use of prescription stimulant medications. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months | 
| Change in Past 6 Month Medical Misuse of Prescription Stimulant Medication | Assesses past 6 month medical misuse of prescription stimulant medication. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months | 
| Change in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool) | Assesses problematic use of tobacco, alcohol, prescription, and illicit drugs over the past year and 3 months. Response options included: 0= Never, 1= Less than Monthly, 2= Monthly, 3= Weekly, 4= Daily or Almost Daily. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months | 
| Change in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants Only | Measures past 3 month non-medical use of prescription stimulants and associated negative consequences. Items were summed to create a scale summary score where higher values indicated more problematic use in the past 3 months (min=0, max=40). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months | 
| Change in Past 6 Month Prescription Stimulant Use Consequence Questionnaire | Assesses negative consequences associated with prescription stimulant misuse over the previous 6 months. A score of 0 indicates that a given consequence did not occur and a score of 1 indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=19). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | 6 and 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peak Quantity of Alcohol Consumed in Past Month | Assesses quantity in standard drinks of peak drinking episode of alcohol consumption over the past month. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months | 
| Change in Past 6 Month Daily Drinking Questionnaire | Assesses typical alcohol consumption over the course of a typical week. Responses for number of drinks consumed each day of a typical week were summed to create a summary score of total number of drinks consumed over a typical week. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months | 
| Change in Past 6 Month Rutgers Alcohol Problem Index | Measures negative alcohol-related consequences experienced over the past 6 months. A score of 0 indicates that a given consequence did not occur and a score of 1 indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=26). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months | 
| Change in Past Year, 6 Month, and 30 Day Marijuana Use Frequency | Items measure typical frequency of marijuana use and number of days used in the past year, 6 months, and 30 days. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months | 
| Change in Past 6 Month Rutgers Marijuana Problem Index | Measures negative marijuana-related consequences experienced over the past 6 months. A score of 0 indicates that a given consequence did not occur and a score of 1 indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=26). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months | 
| Change in Frequency of Past Month Alcohol Consumption | Assesses frequency (days) of alcohol consumption over the past month (min=0, max=31). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months | 
| Change in Typical Quantity in Standard Drinks Consumed on a Typical Occasion in the Past Month | Assesses typical drinking quantity in standard drinks of alcohol consumed during a typical drinking occasion over the past month. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |