Personalized Health Assessment Related to Medications (Project PHARM)
Condition: Feedback, Psychological; Clinical Trial; Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

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.
    

Intervention name(s): Web-based PFI; Assessment Only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment