Personalized Health Assessment Related to Medications (Project PHARM)
Phase: NA
Conditions: Feedback, Psychological, Clinical Trial, Substance Abuse
Sponsor: University of Washington

Official title: Personalized Health Assessment Related to Medication (Project PHARM) 
NCT number: NCT03037476 
Document date: August 23, 2019 
Document:  Study Protocol and Statistical Analysis Plan 
 

Research Strategy 
 
SIGNIFICANCE 
Definitions and Importance of Problem: Non-medical use of prescription drugs has been defined as 
“using a psychotherapeutic drug, even once, that was not prescribed for you, or that you took for only the 
experience or the feeling it caused”10. In addition, medical misuse of prescription drugs4, 16 refers to taking a 
medication at a higher or more frequent dose then prescribed. This application focuses on both kinds of 
misuse (non-medical and medical) of prescription stimulant medications (PSM; e.g., Adderall, Ritalin) which 
are the fastest growing class of illicit drugs20, 21.  PSM misuse is most prevalent among adolescents and young 
adults11, 15-19 with college students at high risk for PSM misuse20. Given the academic and other pressures 
faced by college students, PSM are likely to be misused by students to stay awake and alert in order to 
complete their work and study for exams. PSM have a high potential for abuse due to their reinforcing 
properties, and improper use can have potentially serious health effects, especially for individuals with 
underlying cardiac conditions. McCabe and colleagues suggested that college campuses provide an “ideal 
environment” to foster PSM misuse, due to increased access to substances on campus, cultural acceptability 
for substance use, and peer pressure,20 and also suggested college students may be at higher risk for PSM 
misuse, given the higher accessibility of different medications on campus, and the likelihood of students 
sharing their prescriptions with others25. For example, in a Canadian study, 78% of college students who 
engaged in PSM misuse reported obtaining the PSM from a friend or acquaintance holding a prescription for 
it26. College students who had PSM prescriptions are often approached or invited to divert these medications 
with up to 60% of those holding a prescription reportedly giving away or selling their PSM4, 16, 179, 181.  
Prevalence Rates and Consequences. Epidemiological trends indicate an increase in PSM misuse 
among young adults and college students, and rates are at their highest level in 15 years, which poses a 
growing public health concern20, 21, 23, 181. Estimated prevalence rates vary widely; in over 25 studies of college 
student PSM misuse conducted through 2009180, estimates ranged from a low of 5.9% for past 30 days, to a 
high of 36% for lifetime prevalence in a general sample and 55% for lifetime rate in a fraternity sample4, 24, 27, 28, 
180. Our own work has revealed that, by the fourth year of college, at least 31% of students have engaged in 
PSM misuse at least once in their lifetime, and annual prevalence peaks during the third year of college at 
approximately 20%1.  In addition to rising prevalence rates, there are many consequence of PSM: headaches 
(33% of users), stomachaches (33%), irritability (62%), sad mood (25%), and sleeping difficulties (72%)4, 29. 
PSM misuse has also been associated with health issues including cardiovascular failure, jitteriness, 
hyperthermia, seizures, and anxiety12, 186. Compared to students who do not, those who misused PSM also 
had more social difficulties, had lower GPA, and reported concerns about their academic performance29-31. Our 
research has also found students who misuse PSM skip classes more frequently and spend less time studying 
than those who do not use or who use only as prescribed27, 147.   
PSM Misuse and Co-occurrence of AOD. We have consistently shown that PSM misuse is also a marker 
for heavy AOD involvement as it seldom occurs in isolation1, 145-147. Students who engage in PSM misuse are at 
risk for a host of issues related to alcohol and marijuana use compared to those who do not use PSM and 
those who use but do not misuse (i.e., take the PSM as prescribed), including being more likely to have used 
other drugs, to report frequent binge drinking, and more likely to drive after binge drinking than other college 
students4, 29-30, 33, 36-37, 131. Adolescents and young adults have particularly high rates of concurrent poly-drug 
use with up to 90% of past-year PSM misusers reporting using other drugs, particularly marijuana31, 33-35. 
Students who misuse PSM are more likely to meet diagnostic criteria for dependence on alcohol and 
marijuana, and are more likely than students abusing other drugs to report any drug related problems and to 
experience nine out of ten drug related consequences as assessed by the Drug Abuse Screening Test-10 
(DAST-10)32-33. Thus, in addition to harm related to PSM misuse per se, considerable harm is related to the co-
occurrence of PSM misuse with excessive alcohol, marijuana, and other drug use.  
Dearth of Interventions and Missed Opportunities. Given the prevalence and consequences of PSM 
misuse on college campuses, the high co-occurrence with alcohol and marijuana, and the academic and public 
health implications, innovative prevention and treatment approaches are critically necessary14, 20, 33, 39-41. 
However, there are currently no documented efficacious interventions targeting college students who misuse 
PSM. The proposed study explicitly leverages expert knowledge (Arria) from existing NIDA-funded research on 
risk factors for PSM with expertise in screening and brief intervention (SBI) for college student alcohol and 
marijuana misuse by leaders in the field (Geisner, Kilmer, Larimer, Lee, Cimini) to develop and test such an 
intervention on three college campuses, in order to attack the problem of PSM misuse and bridge this 
important research and service gap. Consistent with other interventions in the college setting, we propose to 

use brief interventions whose primary target will be PSM misuse; however there is evidence that these types of 
interventions will have secondary effects/reductions on other substance use166. Thus, our approach is 
significant as it has the potential to be both efficacious and highly efficient for reducing PSM misuse and 
related comorbid alcohol and marijuana use in a high-risk population (i.e., college students).  
Evidence for Brief Interventions with College Students. The proposed intervention builds on the 
success of existing Brief Motivational Interviewing (MI)168 strategies such as Brief Alcohol Screening and 
Intervention for College Students (BASICS)5,6, but adapts the approach to focus on PSM misuse in addition to 
comorbid alcohol and marijuana misuse. The BASICS program incorporates personalized feedback regarding 
normative perceptions and actual norms, motives for using, and strategies to minimize negative consequences 
from alcohol use, and has been deemed by the NIAAA Task Force on College Drinking Prevention as a Tier 1 
Intervention63, 64. Several theories underlie BASICS, including Social Comparison65 and Social Learning 
Theory66 which suggest people compare themselves to others as a way to evaluate appropriateness of their 
own behavior and learn by watching others. While BASICS targets alcohol use, other substances have been 
the focus of in-person feedback-based interventions patterned after BASICS. For example, an in-person, 
personalized feedback intervention (PFI) for marijuana designed and evaluated by members of our team 
showed reductions in number of joints used and a trend toward fewer consequences compared to controls169. 
Thus, adapting PFIs to address PSM misuse is timely and fills a critical need. 
Prior research suggests that college students’ beliefs about the health risks and academic benefits of PSM 
are malleable, and that intervening on academic beliefs may reduce likelihood of future PSM misuse170.To 
date, however, we are aware of only one intervention study with PSM, and it sought to change college 
students’ expectancies regarding benefits of PSM rather than misuse per se171. Looby and colleagues’ 
intervention involved presenting the student with research-based information about the lack of evidence for a 
cognitive enhancement effect from PSM, and inviting the student to personalize that information based on 
feedback about how their own cognitive performance and subjective mood and arousal changed in response to 
a placebo substituted for methylphenidate. While the trial171 did not show a reduction in PSM misuse, which 
may have been due to their decision to focus on PSM initiation among stimulant-naïve students, it did 
demonstrate the efficacy of a face-to-face intervention for changing college students’ expectancies about PSM. 
The proposed work will build on our expertise in brief interventions by presenting personalized feedback about 
students’ experiences with and beliefs surrounding PSM misuse alongside information about actual norms, 
outcomes, and effects to elicit personally relevant reasons for changing. Translating this strategy into a more 
clinically feasible approach, the proposed intervention will leverage MI strategies as an alternative way of 
encouraging students to personalize research-based information. By developing discrepancies between values 
and goals of importance to the student (e.g., “everyone is using these and I want to do well academically too”) 
and ways in which the status quo could be in conflict with these (e.g., a minority of students report use, and 
those who use have lower grades), the feedback is designed to prompt contemplation of and a commitment to 
change.  
Web-Delivered Intervention. Derivatives of BASICS such as Web-based PFIs have been efficacious in 
reducing college student drinking 58-62. Personalized normative feedback (PNF) interventions for college 
student alcohol use67-68, which focus primarily on correcting misperceived descriptive norms by providing 
accurate normative feedback, have evolved from BASICS and resulted in significant effects on drinking 93-96. 
There is reason to believe normative feedback may have a similar impact on PSM misuse given recent data 
suggesting widespread normative misperceptions for PSM156. Thus, Study 1 aims to document accurate 
norms on each of the three participating campuses, in order to adapt normative feedback components of a PFI 
for PSM misuse. Consistent with preliminary research, we hypothesize that students’ perceived norms of PSM 
will be greater than actual norms and these normative perceptions will relate to student’s own PSM. 
Costs associated with personalizing information via the Web are quite low, suggesting wide potential reach 
and resultant public health benefit of even modest improvements42, 43, 45. Internet-delivered tailored prevention 
or intervention materials have targeted a range of health behaviors with a variety of populations42, including 
tobacco use43-44, 47-52, depression and anxiety53-57, and drinking58-62. Web approaches are attractive in a stepped 
care model due to cost-effectiveness, personalization, and widespread accessibility of the internet42-44. This 
approach may be ideal for students, as younger individuals not only wish to access health information through 
technology, but are critical of more traditional methods46. Thus, Study 2 aims to reach college students who 
engage in PSM misuse through web screening and intervention42. We hypothesize that participants who 
receive the PFI will reduce PSM misuse assessed at follow-ups. We 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. We 

further expect secondary effects of the intervention on alcohol and marijuana use, and expect these reductions 
will partially mediate PSM outcomes (see Mediators below). Finally, we will explore PSM motives and 
demographics as potential moderators of intervention efficacy (see Moderators below).  
In Person Feedback in Student Health and Counseling Centers. With well documented barriers related 
to implementing approaches developed in a lab setting or in the context of a research trial to “real world” 
clinical settings, Study 3 will test the efficacy of the PFI in a Student Counseling and Health Center at a large, 
diverse public university in the Northeastern U.S. Students presenting with medical and/or mental health 
concerns will be screened for PSM misuse as well as AOD use as part of their routine care and will be offered 
either an in-person session, the web-based PFI, or assessment only control based on random assignment. For 
practical purposes related to staff time in a busy clinical setting, web-based PFI, if effective with this population, 
would be preferable; however, if in-person PFI outperforms the web-based (or only under certain conditions for 
certain students), this will help identify how to best serve students who may be struggling. An important aspect 
of our in-person approach will be to use the student’s past experiences with PSM as a starting point. An MI-
trained interventionist will help the student to develop discrepancies, elicit change talk, provide students with 
opportunities to more thoroughly explore and question their beliefs, and offer alternatives by reviewing their 
personalized responses. MI has been an effective approach for other interventions, and it is an appropriate 
modality for this target population. Thus, Study 3 aims to determine whether and for whom in-person 
implementation of the PFI is more efficacious than web-based PFI in reducing PSM misuse and co-occurring 
alcohol and marijuana use. We hypothesize both web- and in-person PFI will be more efficacious than control. 
We also hypothesize in-person intervention will be more efficacious than web, particularly at long-term follow-
up (18-months), given some literature suggesting advantages of in-person PFI emerge over longer periods200. 
As with Study 2, we expect reductions in perceived benefits and norms of PSM and increases in alternative 
behaviors will mediate efficacy of both interventions, as will reductions in alcohol and marijuana use. We will 
explore demographics and PSM motives as moderators of overall and differential efficacy.   
Moderators: Motives for PSM misuse and Demographics. Evidence suggests students misuse 
prescription stimulants for a variety of reasons91-92, 159, 177. Understanding motives for PSM misuse is important 
to identify necessary intervention components and to determine for whom interventions are most useful. 
Motivational models of substance use suggest behavior is motivated by different reasons, leading to 
theoretically and psychologically distinct behaviors195, 196. Different motivations are associated with unique 
patterns of use and consequences, influencing when or where one will use a substance, how frequently or how 
much one will use, and what consequences may occur195, 196. Studies of PSM use through alternative 
assessment methods (e.g., Twitter and Wastewater analysis)182-184 have confirmed that PSM use among 
students peaks around mid-terms and finals, supporting that perceptions of academic benefit and academic 
motives lead to PSM misuse among students. Indeed, self-reported motives for use among students include 
improving concentration, to help with studying, enhance academic performance, and, with less frequency, to 
counteract effects of other drugs, lose weight, experiment, and/or get high1, 3, 29, 91-92, 159, 177. Overall, reasons for 
PSM misuse have been characterized into three main categories: academic motives, partying motives, and 
both academic and partying motives. The proposed intervention addresses each of these motives for PSM 
misuse. Students who engage in PSM misuse for academic reasons may benefit differently from those who 
use it more for recreational reasons. Each kind of user may benefit from alternative strategies to achieve 
desired academic and/or social outcomes rather than relying on PSM. Thus, the current study will explore 
whether student’s motives for PSM misuse will moderate intervention efficacy.  We will also explore whether 
characteristics including gender, race/ethnicity, and fraternity/sorority status moderate intervention effects.  
Mediators: Alcohol and Marijuana Comorbidity with PSM Misuse. Given the high correlation between 
PSM misuse and AOD, it is possible to conceptualize motives for PSM misuse as related to consequences of 
AOD. For students who report partying motives for PSM, the relationship between AOD use and PSM misuse 
is intuitively obvious in light of a shared propensity hypothesis. In some cases, students are seeking feelings of 
euphoria or a buzz from PSM1, 145 just as they do with other substances. In other cases, the appeal of PSM is 
in its ability to deliver wakefulness, which allows the user to extend a drinking session and thereby consume 
more alcohol1, 147. Yet even when the motives for PSM misuse appear to be purely academic, PSM misuse 
may still be closely linked to AOD use as a compensatory strategy, whereby students turn to PSM in hopes of 
making up for the classes and study time they missed as a result of their AOD use, or possibly to manage side-
effects of their alcohol and/or marijuana use. In the context of the college setting, heavy alcohol use has been 
associated with lower GPA, less engagement with faculty, and increased sleepiness160-162; conceivably, PSM 
could be used to combat and counter problems with fatigue and tiredness. Marijuana use is associated with 
deficits in attention, concentration, and memory, and this impact is more pronounced the more frequently 

someone uses, though shows improvement with sustained abstinence163-165. In fact, longitudinal analyses our 
team has conducted support the conclusion that PSM occurs in the context of AOD-related declines in 
academic performance147. Specifically, increases in alcohol and marijuana use over time appear to contribute 
to declines in class attendance, which in turn contribute to declines in GPA, and this cascade of events is 
strongly predictive of students engaging in PSM misuse for studying. In an intervention focused solely on 
reducing PSM misuse, most PSM misusers would have little room for decreasing their misuse due to the 
episodic use patterns (primarily around mid-terms and finals). Thus, in addition to directly targeting PSM 
misuse through a PFI, another reason for this application’s significance stems from its focus on reducing PSM 
misuse directly as well as targeting intervention components for co-occurring alcohol and marijuana misuse 
(mediators in Studies 2 and 3). We hypothesize that PFI will lead to reductions in comorbid alcohol and 
marijuana use, and that reductions in alcohol and marijuana use will serve to mediate reductions in PSM 
misuse. By focusing holistically on the student’s underlying substance use problems, an intervention targeting 
PSM misusers could have a substantial impact on a subset of college students who are at particularly high risk 
for co-occurring AOD use and associated consequences. Delivery of intervention components will be targeted 
to high risk times in the academic calendar to maximize benefits. 
Mediators: Beliefs, Perceptions, and Alternatives. Guided by the Health Belief Model, our approach  
targets students’ beliefs about benefits of PSM, based on evidence that higher perceived benefits and positive 
beliefs about PSM predict greater likelihood of use25, 27, 31, 170, 171, 176, 177, 178. Such beliefs can be impacted by 
academic and health-related information170.  According to the prototype-willingness model, motivation that 
drives behavior can be used to reduce thoughts associated with the behavior itself170. That is, given that PSM 
is primarily academically motivated, the proposed intervention will leverage the student’s underlying academic 
motives to create ambivalence about PSM misuse and cultivate motivations toward increasing alternative 
behaviors (i.e., regular class attendance, studying, sleep) and bolstering academic self-efficacy. At the same 
time, the intervention will also provide information about risk-factors accompanying PSM misuse as supported 
by the literature (i.e., increased AOD, lower GPA), which will help students develop less favorable perceptions 
about PSM and thereby reduce their own likelihood of future use. We hypothesize reductions in expected 
benefits of PSM will mediate efficacy of both web-based (Study 2 and 3) and in-person (Study 3) PFIs.   
Next, we will target students’ descriptive norms about how many of their peers engage in PSM misuse. 
Similar to research with alcohol, it has been suggested that college students over-estimate the prevalence of 
PSM use/misuse on their campuses, which may contribute to an erroneously held view of the normality of this 
behavior80, 167. For example, in one study176 71.4% of students reported PSM misuse among their peers, 
however only 9.2% actually used them. In another study8, 60% of college students knew someone who used. 
Our own recent study156 demonstrated that almost all college students (89%) inaccurately perceived the typical 
student as having used PSM (medically or non-medically) at least once in their life. Such misperceptions were 
associated with their own higher PSM misuse as well as higher hazardous drinking, prompting the suggestion 
that interventions aiming at correcting norms 
may be useful80, 156. We hypothesize 
reductions in perceived descriptive norms 
for PSM use will mediate both web- (Study 2 
and 3) and in-person (Study 3) PFI efficacy.  
Finally, the perceived benefits of healthier 
alternatives such as reducing AOD use, 
getting adequate sleep, studying regularly, 
and attending class will be targeted. 
Protective Behavioral Strategies (PBS)81-87 
have been related to reductions in problem 
drinking and account for treatment effects in 
college and community samples64, 88, 82-84, 89-
90, thus it is important to develop and test healthier alterantives for PSM misuse. We hypothesize that 
increased use of alternative strategies to achieve desired academic and social benefits will mediate efficacy of 
both web-based (Study 2 and 3) and in-person (Study 3) PFI.  
(b) Innovation: 
The proposed research is innovative for several reasons: 
1. Novel interventions to be adapted from existing methodology and tested with PSM: There have been 
no interventions of any kind developed for students who misuse PSM, and only one published intervention has 
targeted delay of onset of PSM through changing expectancies in this population. Lessons learned from prior 

research on brief interventions88, 98-100 will be applied to intervening with PSM misuse and comorbid AOD use in 
college students, representing an innovative response to this multi-faceted issue. The proposed feedback 
includes components uniquely relevant to PSM and the behaviors surrounding their misuse (e.g., diversion of 
medication). With the potential for attention problems interfering with full, sustained review of lengthy 
personalized feedback by the student, the current study breaks feedback down into concrete sections 
strategically delivered over the course of the quarter/semester. Students can go back and view the salient 
components of the intervention as often as they wish, also meeting the needs of a sample with potential 
attention challenges. Understanding factors influencing outcomes (e.g., motives, concurrent use with other 
substances) will help to further identify how to target interventions to maximize gains. Once the adapted 
materials are tested, larger trials can provide more evidence and aid in dissemination. Programming used for 
the intervention is easy to modify and relatively inexpensive to adapt for other campuses. Thus, this low cost104-
105, brief, personalized intervention fills an important gap in the services available at present for college 
students who misuse PSM.  
2. Collaboration between a team of experts. The research project will be conducted by a team with 
expertise in the epidemiology and treatment of PSM and co-occurring AOD use. We have been instrumental in 
understanding the risk factors and correlates of PSM in college students and in developing and testing 
efficacious in-person and web-delivered SBI/PFIs with college populations. Perceived descriptive norms and 
the overestimation of peers’ risk behaviors are pivotal in the development and maintenance of college student 
drinking and marijuana use, and correcting these misperceptions is effective at reducing both use and related 
harms.69, 70-79 Our team has been at the forefront of developing and testing such interventions5, 71, 74, 88, 93, 108-110, 
134, 137, 138, 143, 144. Given that no interventions have been developed or tested with college students who misuse 
PSM, we are uniquely qualified to adapt and test evidence based treatments in reducing the misuse of PSM. 
3. Shift current clinical practice paradigms in real world healthcare settings: The proposed project 
reaches beyond laboratory research by testing the study interventions in a campus-based primary health and 
mental health care setting, offering the opportunity to address issues of capacity-building, intervention fidelity, 
and cost-effectiveness as interventions are prepared to be taken to scale through dissemination. Study 3 is a 
natural extension of nearly a decade of work in building service delivery capacity by the Principal Investigator 
(Dr. Cimini), and practitioners at the Health Center and Counseling Center of the University at Albany, SUNY. 
With funding support from the Substance Abuse and Mental Health Services Administration, Center for 
Substance Abuse Treatment (SAMHSA-CSAT), Albany has built both research and service-focused 
infrastructures to deliver and evaluate SBI for alcohol use with fidelity in both the Health Center and 
Counseling Center. Based on the strength of our project results, we have received the attention of the White 
House Office of National Drug Control Policy, and our published work related to this project has informed the 
President’s 2009 and 2012 National Drug Control Strategy. Because there are currently more than 21.6 million 
individuals enrolled in colleges and universities across the nation (U.S. Department of Education, 2012), many 
of whom seek medical and mental health services from agencies within their institutions of higher education for 
presenting problems unrelated to their drug use, early intervention for PSM and AOD use within a college or 
university setting as part of routine medical and mental health care is a promising, innovative, cost-effective, 
and evidence-based strategy to investigate through research. The proposed study will assist both researchers 
and practitioners in identifying key implementation considerations when applying what has been learned in the 
laboratory to busy health and mental health care settings facing competing service demands, limited 
resources, and associated challenges to intervention fidelity. It will identify what is most important so we can 
take such interventions to scale across the nearly 4500 colleges/universities in the U.S. 
4. Excellent potential for national dissemination based on the linkages that exist among the project 
team members and their broader networks of both scientists and practitioners. This application seeks to 
create an approach to early intervention for college students who engage in misuse of PSM by adapting web-
based brief interventions. With PSM misuse gaining attention in the scientific literature and popular media, 
interest in responding effectively on college campuses is at an all-time high. With existing partnerships with 
national organizations already committed to addressing this issue (e.g., Drs. Geisner, Kilmer, & Larimer 
working with NASPA; Drs. Cimini & Kilmer working with Dartmouth’s National College Health Improvement 
Program), statewide initiatives that emphasize efforts to bring science to practice (e.g., Dr. Arria’s leadership 
role in the Maryland Collaborative to Reduce College Drinking and Related Problems, Dr. Kilmer’s position as 
chair of Washington’s College Coalition for Substance Abuse Prevention), and successful efforts to translate 
research findings for everyone from parents to policy makers, this team is uniquely positioned to focus on 
dissemination with an emphasis on “real world” applications on and relevance to college campuses.   
(c) Approach 

Preliminary/Pilot Studies: Dr. Arria is synonymous with the study of PSM and has conducted the largest 
longitudinal study to date (the NIDA-supported College Life Study) addressing the linkages between college 
students’ AOD use—including PSM—and outcomes such as academic performance and persistence, post-
college employment as well as on motives for PSM misuse27, 41, 145-149. Drs. Geisner, Larimer, Kilmer, and Lee 
have conducted or collaborated on numerous studies of college student substance use (alcohol, marijuana, 
and PSM) and related problems directly relevant to the proposed research88, 106-108, 143-144, 156, 169. We have 
conducted several RCTs of in-person feedback interventions for alcohol and marijuana, in addition to RCTs of 
computer- and web-delivered feedback for alcohol as a stand-alone intervention, with between-subjects effect 
sizes ranging from medium to large on normative perceptions (d = .61-.96) and drinking behavior (d = .35-.97) 
relative to assessment only93, 96. Dr. Cimini and her team have been translating research findings on prevention 
and intervention using a public health approach to a large public university-based primary health and mental 
health care delivery setting150-155. Our research team has demonstrated 1) a thorough knowledge of conducting 
research with college students who use and misuse PSM; 2) success in developing and evaluating efficacious 
interventions, including computer/web feedback and in-person feedback, in reducing alcohol use, 3) success in 
adapting feedback-based interventions for a variety of other presenting problems, including marijuana, 
gambling, and mood disorders, and for adapting them to in-person, real world settings; 4) success in 
establishing the role of normative misperceptions and AOD use as critical aspects of intervening with PSM 
misuse. Our work also demonstrates feasibility of our recruitment, retention, and intervention procedures. 
1) Misuse of Prescription Stimulant Medication. For the past decade, Dr. Arria has led the NIDA-funded 
College Life Study (CLS), which included over 1250 young adults originally enrolled as college students. She 
has focused on understanding the antecedents and consequences of all forms of substance use during 
college, and in particular on PSM. Her team has numerous publications1, 27, 41, 145-149, 159, 174, 178 on the risk 
factors for PSM misuse and longitudinal interrelationships between PSM misuse and other forms of drug use, 
and academic variables. Two recent studies at UW have also included items regarding PSM misuse. In the first 
(R01AA012547; Larimer PI, Kilmer, Lee Co-Is, Geisner collaborator), a random sample of 1477 students 
completed a web survey of stimulant use, of whom 3.8% reported misuse of their own PSM and 9.8% reported 
misuse of another’s PSM in the past year. In the second study, Kilmer and colleagues completed a survey of 
lifetime use among students 18-25 and found that 19% reported PSM misuse. Results also support a need to 
correct misperceptions; despite 81% having never used PSM, 89% believed the typical student had used for 
non-medical reasons at least once156.  Drs. Geisner, Kilmer, and Larimer have also recently begun (July 2014) 
a collaborative project with the National Association of Student Personnel Administrators (NASPA) to better 
understand trends, perceptions, motives, and effects related to PSM misuse. The UW team will lead a 9 
campus initiative to develop and conduct surveys and in-person focus groups with students and administrators 
to explore implications for prevention campaigns and make suggestions for intervention development – 
information from this project will undoubtedly set the stage for even greater success with the proposed 
research.  
2) Alcohol Use Interventions. We have been involved in development, implementation, and evaluation of 
individual-focused alcohol prevention approaches targeting at-risk students for 10-30 years. Drs. Larimer & 
Kilmer were part of the original development team for BASICS and related brief motivational PFI, which are 
currently recognized as among the best approaches for addressing college student problem drinking6, 98-100. 
The general approach6 has been found to result in significant reductions in alcohol consumption among heavy 
drinking students for up to four years5, 134,135.  Dr. Larimer has been PI of 4 studies of BASICS and related brief 
web-based PFIs for alcohol (R01AA010772; R01AA012547; U01AA014742; R01 AA018276); Drs. Kilmer, Lee, 
and Geisner served as Co-Is or collaborators on these studies. Data from the first of these four studies 
supported in-person PFI among fraternity members as well as provided support for perceived norms as 
predictors of alcohol use and consequences134, 137-140. The second project supported use of mailed PFI as a 
universal prevention strategy88 with significant effects on drinking 12-months post-intervention, and expanded 
our understanding of the relation between high-risk drinking and comorbid problems including depression141. 
Both projects demonstrate our ability to successfully conduct large scale intervention studies with college 
students. We recently demonstrated web-based PFI was efficacious for reducing the escalation of alcohol use 
across the transition out of high school for youth in the U.S. & Sweden142.  
3) Adapting PFI for Illicit Substance Use and Other Disorders. We have adapted web-based PFI for in-
person and online interventions for marijuana use144 (R21 DA025833), and comorbidity of substance use 
disorders and disordered gambling71 (R01DA025051). Drs. Lee (PI), Kilmer (Co-I), and Larimer (Co-I) 
developed a PFI for marijuana that, in an RCT, resulted in intervention effects for amount used and 
consequences169. Dr. Geisner adapted PFI to address the comorbidity of depressed mood and alcohol 

misuse109, and this combined intervention is efficacious in reducing misperceived drinking norms, which were 
related to changes in alcohol use for those with comorbid heavy drinking and depressed mood110. She has 
adapted this intervention for the web (R21: AA019993) and recently finished data collection with similar 
recruitment and up to 90% retention rates. Response rates and retention across all studies are comparable to 
those proposed in the current application. Dr. Cimini and her team have implemented and evaluated the 
effectiveness of evidence-based interventions and prevention practices addressing college drinking and drug 
use across a variety of contexts (including patients in university-based primary health and mental health care 
settings, student-athletes, mandated students, and first-year students) and intervention delivery formats 
(including individual, group, peer-delivered, computerized, mass media, and Web-delivered feedback formats). 
This prior research-to-service experience within the University at Albany’s clinical service delivery settings has 
resulted in the ability to implement these interventions in a standardized manner with a high degree of 
intervention integrity and fidelity, and to provide a thorough evaluation of these programs using a 
comprehensive set of assessment measures. Based on rigorous peer review, the brief alcohol intervention 
developed by Dr. Cimini and her team has been listed in SAMHSA’s National Registry of Evidence-based 
Programs and Practices, recognized for both quality of research and readiness for dissemination. Thus, the 
current study builds on a strong base of preliminary data in support of the proposed intervention and feasibility 
of the methodology.  
4) Perceived norms and AOD as theoretical mediators: We have completed 5 RCTs evaluating efficacy 
of computer/internet delivered PNF for alcohol use among college students93-95,142. Consistent with our 
proposed research hypotheses, drinking reductions in all studies were mediated by changes in perceived 
norms for the typical student, providing additional support for the correction of normative misperceptions as an 
active theoretical mechanism for intervention efficacy. Kilmer and colleagues143 also investigated the impact of 
norm misperception on illicit drug use. 5990 participants provided information on use, perceptions, and 
consequences of marijuana use. Two-thirds of participants reported no marijuana use, but 98% of respondents 
incorrectly predicted the “typical student” used marijuana at least once per year. Estimates of peer use and use 
by the typical student each added significantly to separate equations predicting variance in drug use and in 
related consequences. Dr. Cimini has collected preliminary data at UAlbany supporting misperceptions of the 
norm for PSM misuse. Specifically, students were asked “Within the last school year, do you think the typical 
student at your school used any of the following prescription drugs (for stimulants) that were not prescribed to 
him/ her?” Results indicated 74% of students perceived that the typical student used stimulants within the last 
year, though the actual rate of use on that campus was reported at 25%. Drs. Kilmer and Geisner recently 
published a paper on normative misperceptions of PSM156. Their research similarly found that students 
overestimated PSM misuse by other students and those normative estimates were associated with student’s 
own higher PSM use.  Living in a fraternity or sorority was related to higher PSM use and perceived norms. 
Finally, higher normative perceptions were associated with higher hazardous drinking. Thus, our preliminary 
studies and bio-sketches demonstrate our ability to successfully conduct this research.  
Study Methodology Overview: The proposed RCT aims to examine the efficacy of a PFI for reducing 
PSM misuse. Study 1 will document normative perceptions on each of the 3 participating campuses. Study 2 
will examine the efficacy of a web-delivered PFI adapted and expanded from models like BASICS which will 
contain tailored information on normative misperceptions of PSM misuse, contrasting commonly held 
misconceptions about the benefits of PSM with research-based information about the actual effects of PSM, 
and learning and study strategies as alternatives to PSM misuse compared to a control condition, as well as 
components targeting comorbid alcohol and marijuana misuse. For Study 3, an in-person individually-delivered 
PFI (adapted from web format to face-to-face) addressing PSM and AOD misuse will be compared to the web-
delivered PFI tested in Study 2 and to an assessment only control. The two studies will evaluate outcomes with 
respect to both short-term (6 months) and longer-term (12 and 18 months) reductions in four substance-related 
outcomes: (a) the perceived norms and benefits of PSM misuse, (b) PSM misuse frequency, (c) marijuana use 
frequency, and (d) alcohol use frequency and quantity.  
Setting: Participants will be recruited from three universities: The University of Washington (UW), the 
University of Maryland College Park (UMCP), and University at Albany, State University of New York 
(UAlbany). UW is located in Seattle, WA and UMCP is located nine miles from Washington DC, with each 
school’s total undergraduate enrollment of more than 30,000. UAlbany, which is one of four SUNY University 
Centers, is classified as a Research II and NCAA Division I institution with more than 12,000 undergraduate 
students. All three universities are coeducational and very diverse with regard to race, ethnicity, religion, 
gender, age, disability, and sexual orientation. 

Studies 1 & 2 Recruitment Procedures: A total of 8,172 undergraduates for Study 1 and 15,732 for 
Study 2 aged 18 to 24 (age restricted in order to maintain comparability with prior SBI/PFI interventions with 
college students) will be randomly selected from the University Registrars’ databases across the 3 sites. 
Students will be emailed an invitation to log on to a secure web browser, read a consent statement and 
indicate their willingness to participate in the study. Approximately 50% of invited students will respond to the 
invitation (Study 1 N=4,086 and Study 2 N=7,866).  
Studies 1 & 2 Screening for Eligibility: For Study 1, all students randomly selected from the registrars’ 
databases will be eligible to complete a 30-minute survey via a secure server, regarding PSM use, PSM 
misuse, normative perceptions, AOD use, and other relevant constructs. Participants will be paid $20 for 
completing the survey. Following completion of Study 1, we will select and invite focus group participants at 
UW to get subjective impressions of and suggestions surrounding feedback components and modules drafted 
for the purposes of this application (see Appendix B). We will conduct 5 focus groups of 8-10 individuals at the 
UW involving Study 1 participants who indicate willingness to participate and who have used PSM in the past. 
We will use focus groups in an iterative fashion and provide intervention refinement following feedback elicited 
about the treatment materials. We will then conduct an additional 2-3 focus groups for final reactions and input 
to the PFI intervention. Investigators will then meet to decide what changes (if any) should be made to the 
intervention prior to implementing the PFI for Study 2, based on transcripts and detailed notes taken during the 
focus groups and the consistency of participant feedback regarding various components. Groups will be 
conducted in person, led by two interviewers, and recorded. The primary interviewer will guide discussion 
through open-ended questions, while the secondary interviewer takes notes and observes responses. For 
Study 2, eligibility will be determined based on a brief web-based, self-administered screening questionnaire. 
Screening items will assess PSM use, PSM misuse, consequences, alcohol, marijuana, and other drug use. 
There are two main eligibility criteria for Study 2. First, to allow for studying academic outcomes, participants 
must be undergraduate students in their second semester or later at the university, have an anticipated 
graduation date at least 18 months in the future, and be planning to remain at their home university for at least 
18 months. Second, to study possible reductions in PSM misuse but to include all students who maybe 
engaging in risky behaviors, participants must have engaged in PSM misuse once or more in the past month 
and/or 6 or more times in the past year. Based on prior studies4, 24, 27, 28, 112, 156, we expect 14%-20% will meet 
criteria for PSM misuse and agree to participate. Students will be paid $10 for completing screening for Study 
2. Up to six reminders to participate will be emailed111. The IRB at each institution will approve all procedures.   
Study 2 Baseline and Randomization: The web-based screening survey will automatically generate an 
eligibility determination. Students who are ineligible will be shown a message thanking them for their interest in 
the study and directing them to campus resources that are available to them if they wish to discuss AOD 
issues. Those meeting the eligibility criteria above will automatically be directed to complete the baseline 
assessment measures. Once baseline is completed, students will be randomly assigned to either an 
intervention group (PFI) or assessment only control (AOC) group. Those in the intervention will immediately 
receive online personalized feedback (see below) on their PSM misuse, academics, and links to alternatives. 
Over the course of the quarter/semester, students in the intervention group will receive a link to view 4 
additional modules surrounding PSM misuse, AOD use, Consequences, and Beliefs/Motives about PSM use. 
The AOC group will receive a “thank you” screen providing referrals/emergency numbers. Students will be 
assessed at 6, 12 and 18 months post-baseline using similar email invitations and reminders (expected 
retention 90% based on past research). Participants will be paid $20, $25, and $30 for each follow-up survey. 
Students who indicate significant alcohol or drug dependence will be contacted and referred (See Human 
Subjects). We will make any indicated adjustments/refinements to feedback based on findings prior to Study 3. 
Study 3 Recruitment, Randomization & Assessment Procedures: All students who present for services 
at the University at Albany Health Center and University Counseling Center will be invited to complete a brief, 
web-based assessment of their PSM and AOD (identical to Study 2) in order to assess eligibility for Study 3 
before meeting with their service provider. Routine screening is already part of ordinary clinical practice at 
UAlbany Health and Counseling Centers, and annually more than 1300 unique individuals visit these centers 
and complete routine screening. Our own pilot data suggests more than 2/3 of heavy illicit substance users 
make at least one visit to a campus health clinic annually, indicating these settings are ideal for identifying non-
treatment-seeking at-risk PSM users.  During the student’s medical or counseling appointment, the provider 
will review the Screening Questionnaire and will refer eligible students to the study using a referral script 
similar to ones from prior studies successfully conducted in this setting. The same eligibility criteria will be 
used: students must have misused PSM once or more in the past month and/or 6 or more times in past year. 
Students agreeing to participate in the study will be emailed an invitation to log onto a secure web browser, 

read a consent statement and indicate their willingness to participate in the study. Those indicating their 
consent will immediately be routed to the baseline survey which will be used to generate the web-delivered or 
in-person PFI content and for which they will receive $20. Following baseline, participants will be randomly 
assigned to one of three conditions (n = 100 per condition). For Study 3, students will be randomly assigned to 
either a web-delivered PFI (as in Study 2), a one-session face-to-face brief intervention delivered in an MI style 
using the PFI as generated in the web condition, or an assessment only control group.  
Participants will complete a battery of web-based follow-up assessments at 6, 12, and 18 months post-
baseline for which they will receive $20, $25, and $30, respectively. Participants will additionally complete a 
brief post-intervention assessment of satisfaction with services and convenience of the intervention, and at 
each assessment they will be asked whether they have sought other drug treatment since the intervention to 
control for possible confounding treatment effects. These data will help determine the ideal interventions for the 
service delivery settings in regard to ease of access and utilization by participants. 
Study 3 Training and Ongoing Supervision of Interventionist: One potential method for maintaining or 
enhancing the efficacy of individual brief interventions for college students seeking campus health and mental 
health care beyond the life of a research project is to train and supervise existing service providers to deliver 
the feedback interviews. The current approach will provide training to enhance existing knowledge of the 
UAlbany Counseling and Health Center staff regarding PSM misuse, and will utilize an existing provider 
imbedded in the Counseling Center staff at UAlbany to provide the in-person interventions. The provider will 
complete specific additional training related to both the MI process and PSM, alcohol, and marijuana content of 
the proposed intervention, and will participate in weekly supervision meetings with Drs. Cimini and Rivero. In 
addition, all intervention sessions will be audio-recorded and reviewed for adherence to the protocol and MI 
competence using existing protocols developed for use in prior funded projects at UAlbany and UW. The 
interventionist will also complete an adherence checklist after each individual session, to indicate which 
components were covered in each intervention session. Scores on adherence/competence measures and 
checklists will be reviewed and included as a covariate in secondary analyses of intervention efficacy.  
Measurement and Assessment Procedures: Measures will be completed via a secure web survey, using 
DatStat Illume and will last 30-45 minutes. Measures selected are in Appendix A.  
PSM Measures 
PSM Use 
DV 
 PSM Timeline Followback (TLFB) - Quantity and past-30-day frequency of 
PSM misuse188   
 Medical Use, Medical Misuse, and Non-Medical Use Questionnaire23, 80  
PSM Consequences 
DV 
 Drug Abuse Screening Test (DAST)32
 The CAGE Questionnaire – Stimulant Use189 
 Prescription Stimulant Use Consequences4
PSM Motivations 
Moderator 
 Prescription Stimulant Use Motives Questionnaire91 
 Motives for Not Using9
PSM Norms and 
Attitudes 
Mediator 
 Prescription Stimulant Norms Rating Form74 
 Attitudes about PSM and Diversion4 
 Prescription Stimulants Expectancy Questionnaire (PSEQ-II)187 
AOD Measures 
AOD Use 
DV/Mediator 
 Quantity/Frequency/Peak Alcohol Use Index6  
 Daily Drinking Questionnaire113  
 Alcohol and Marijuana Timeline Followback (TLFB)9,10 - Quantity and past-
30-day frequency of marijuana and alcohol use, (use days, heavy episodic 
drinking, and typical and peak BAC  
 ASSIST132 - Other drug use
AOD Consequences 
DV 
 Rutgers Alcohol Problem Index (RAPI)191 
 Rutger’s Marijuana Problem Index (RMPI)169,192,193 
Reasons for Not Using 
Moderator 
 Attributions for Limiting or Abstaining from Illicit Drugs (ALAID)9 
Other Measures 
Demographic 
Characteristics 
Covariate/ 
Moderators 
 Standard questions will be used to assess age, sex, sexual orientation, 
race/ethnicity, parental education level, number of hours per week working 
for pay, religiosity, and current living arrangement 
Academic 
Characteristics, Skills 
and Outcomes 
Feedback 
 Learning and Study Strategies Inventory, 2nd edition (LASSI)175 
 Relapse Prevention/Protective Behaviors Scale190 
 Satisfaction with Academic Progress and Skills 
 Factors affecting Academic Performance 
 Activities/Options that Could Improve Grades or Academic Progress

 Primary Academic Outcomes: GPA
 Academic Behaviors 
 College Engagement194 
Satisfaction 
Covariate 
 Participants’ satisfaction with interventions (assessed post intervention)
Personalized Feedback Intervention (PFI) Materials: Intervention materials for the web-PFI will be 
programmed using the Datstat Illume Software Development Kit. Custom programming will link feedback to the 
baseline survey to populate feedback fields with personalized information related to participants’ PSM misuse, 
AOD use, consequences, norms, and academic behaviors. We have previously utilized this system 
(R01AA012547; R01AA012529; R01AA016099; R21AA019993; R21DA019257) to program feedback with 
multiple conditions, and protocols can be adapted for the current study. We will track feedback completion via 
Illume, including number and length of times spent reviewing feedback and will control for these in analyses115. 
Due to the possibility of attention difficulties in this population, feedback will not be a lengthy, single 
administration, but include 5 customized modules for participants to review over the quarter/semester. 
Prescription Stimulant Medication Misuse PFI. The intervention is comprised of personalized feedback 
presented in text and graphic format, and each component is followed by a link to tips for making changes if 
and when the participant is contemplating or ready to commit to change. These tips will 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 
initiating behavior change will also be included. The first component of the feedback targets PSM and 
academics, including student’s own prescription stimulant use frequency, satisfaction with academic progress 
and grades, factors identified by the student as interfering with academic performance, sense of their time 
management and study skills, impact of alcohol and marijuana use on academic/cognitive factors, student-
identified actions that could improve academic success, and resources for getting assistance with academic 
support. The second component targets PSM and perceived norms, including perceived and actual past year 
use, perceived and actual past-quarter/semester frequency, requests to divert PSM (both requests to others 
and to themselves), perceptions surrounding diversion, attitudes about helping others, and what the science 
shows about academic impact. By building a discrepancy between student’s own PSM misuse and that of 
others, as well as correcting their perceptions of other’s use (norms reduction) and beliefs about PSM, the 
intervention will reduce PSM misuse. This component ends with campus-specific resources for assessment 
and support. Component three addresses PSM and unwanted effects, with a review of consequences related 
to PSM use, the science behind PSM misuse, and a link to alternative strategies. In the fourth component, 
Reasons/Motives for using PSM are addressed, including when during the academic year the student tends 
to use, motives for PSM use, and reasons to limit/avoid use. The final component reviews Alcohol, Marijuana, 
and Drug Interactions. For marijuana use, participants will receive personalized feedback about frequency of 
use, consequences, and perceived norms; for alcohol use, they will receive information on frequency, quantity, 
norms, BAC and related effects, and consequences. The section ends with information on drug interactions. 
Appendix B includes a draft of proposed feedback, to be refined and programmed during the start-up phase.  
Face-to-Face Personalized Feedback Intervention. The face-to-face intervention is an enhanced version of 
the web-based PFI described above.The intervention will be adapted by Dr. Cimini’s team in consultantion with 
the UW research team to be appropriate for in-person delivery. The face-to-face intervention will consist of a 
1.5-hour intervention intended to discuss the student’s PSM misuse, AOD use, and review personalized 
graphic feedback. The interventionist will use motivational interviewing principles168 throughout, including 
expressing empathy, developing discrepancies, rolling with resistance, and supporting self-efficacy. Review of 
personalized feedback will be used to facilitate the building of discrepancies by illustrating areas in which the 
student’s AOD use may be in conflict with important goals or could be incongruent with the student’s 
impression of the impact of their use. In the review of feedback, the provider listens for and reflects “change 
talk” (statements made by the student that indicate concern or need for change), and can elicit “change talk” 
with evocative questions and other strategies suggested by Miller and Rollnick168. While the layout of the 
feedback is consistent across participants, individual content within domains on the feedback will be directly 
tailored to the individual based on his/her baseline survey responses. Further, the motivational discussion with 
each participant is tailored to their responses to the feedback, level of readiness to change, and interest in 
particular feedback topics. Specifically, because MI involves a variety of active listening strategies (simple and 
complex reflections, open questions, affirmation, and strategic responses to resistance) the conversation is 
inherently tailored to each participant’s unique reaction to the feedback and his or her concerns, questions, and 
goals. The personalized graphic feedback illustrates the impact of PSM misuse and AOD use in multiple 
domains to facilitate a conversation about patterns of use and consequences.  
Data Analysis: Prior to performing inferential tests of hypotheses, univariate and bivariate descriptive statistics 

will be conducted to examine the distributions of and correlations among key study variables. 
Evaluation of Specific Aims:  
Aim 1: To examine whether perceived norms of PSM differs from the “actual” prevalence as estimated by the 
screening sample, the actual prevalence will be subtracted from the perceived prevalence. A one-sample t-test 
will be used to assess whether the difference score is statistically significantly greater than 0. If the difference 
score is a non-normal distribution, we will instead use a non-parametric Wilcoxon sign rank test.  
Aim 2: Evaluate efficacy of interventions. We will first examine effects of the intervention on perceived norms, 
benefits of PSM, and use of alternative strategies as separate outcomes using linear mixed models (a.k.a. 
hierarchical linear or multilevel models120). This project will have 5 repeated measures, yielding up to 6,000 
Level 1 observations (repeated-measures) across 1,200 Level 2 (people). The following equation represents a 
basic analytic model for Aims 2 and 3:  
 
Level 1:  
Yti = π 0i + π1i(Post)i + π2i(Month6)i + π3i(Month12)i + π4i(Month18)i 
 
Level 2:  
π 0i = β 00 + β 01(Tx)i + β 02(Site)i  + r00i 
 
 
 
π 1i = β 10 + β 11(Tx)i + β 12(Site)i   
 
 
 
π 2i = β 20 + β 21(Tx)i + β 22(Site)i   
 
 
 
π 3i = β 30 + β 31(Tx)i + β 32(Site)i   
 
 
 
π 4i = β 40 + β 41(Tx)i + β 42(Site)i   
where Post, Month6, Month12, and Month18 are dummy codes for follow-up visit such that the reference time 
point is baseline; Tx represents randomly assigned treatment condition; Site represents the study site; i 
indexes participants; r00i represents a random effect for the intercept; and Yti represents the outcome for each 
individual, i, at each time, t. β 11 - β 41 , are primary coefficients as they compare treatment conditions for the 
difference in the outcomes from baseline to each of the follow-up visits. The model assumes conditional 
independence, given random-effects and (multivariate) normality of Level 2 random-effects. As additional 
analyses, we will also specify time as a continuous variable in order to assess differences between intervention 
and control groups in slopes over time. 
 
We will then examine effects on PSM, marijuana, and alcohol use and consequences.  These outcomes 
are integers, bounded at zero, and often times positively skewed. Because of potential violations of regression 
assumptions that can arise due to the non-normal distribution, we will use a generalized form of the linear 
mixed model (GLMM) with a Poisson distribution in order to more appropriately model these outcomes as 
counts117. Count regression coefficients are connected to the outcome via a natural log link and are commonly 
exponentiated (eβ) to yield rate ratios (RRs) describing the proportional increase in the outcome for a 1-unit 
increase in the predictor (e.g., Treatment (1) compared to Control (0)). 
To assess mediation hypotheses, we will utilize an approach that has been used by co-investigators with 
similar data to the proposed study197. Kenny et al.198 described mediation using multilevel models for 
longitudinal treatment data similar to the present data. Specifically, Kenny et al. focused on change in the 
direct treatment pathways from a model without the mediator to a model with the mediator (i.e., the common c 
and c’ pathways in the mediation literature). In the present context, that is the treatment cross-level interactions 
with time (β 11 - β 41) for the model presented above compared to one in which mediators are included as Level 
1 time-varying covariates. We will use this approach and consider the percent reduction in effects after the 
mediator is included in the model. In Neighbors et al199, this approach was extended using a nonparametric 
bootstrap199 to allow estimation of the indirect path without making normality assumptions on the sampling 
distribution of the indirect effect. Perceived benefits and norms of PSM, use of alternative strategies, and 
alcohol and marijuana use will be included as the Level 1 time-varying mediators of interest and PSM use and 
consequences will be modeled as the outcomes. To assess moderators of efficacy, we will include level 2 
covariates for baseline levels of motivations of PSM and demographic characteristics as well as their 
interactions with treatment in the GLMM. 
Aim 3: Efficacy of in-person and web-based interventions. GLMM Poisson regression will be also used to 
test the efficacy of the web-based PFI and in-person MI on reducing PSM use and consequences. Using the 
basic model equation, dummy variables rather than a single treatment indicator will be included as Level 2 
covariates for web-based PFI and in-person MI such that the reference will be the control group. In addition to 
comparisons of the two intervention groups to the control, we will also conduct post-estimation general linear 
contrasts to compare effects of the web-based PFI and in-person MI on the PSM outcomes.  
Missing data and attrition. Our prior research has been successful at retaining participants with 85-93% 
retention over 6 months or longer. GLMMs provide unbiased estimates in the presence of missing data as long 
as it can be considered ignorable. Missing data are ignorable if they are either missing completely at random or 
missing at random after accounting for measured variables in analysis, including outcome at earlier time 

points120. As seen in previous studies, little efficiency is lost in GLMMs with 10%-20% missing data.  
Power. Because count outcomes will typically require a larger sample size to detect effects than 
continuous outcomes, we assess power for the GLMMs for PSM use. Thus, power estimates for the GLMM will 
be conservative for the linear mixed models. For Aim 2, we are not aware of power analysis software to 
estimate power for GLMMs; thus, we used a simulation-based approach. Simulations based on models that 
contain “true” effects can provide an estimate of power. Two-hundred datasets were generated based on the 
model in equation 1 where estimates for fixed and random-effects were guided by previously collected data of 
similar interventions for reducing problem alcohol use and the existing literature. The GLMM model was fit to 
each dataset and specific output were saved (e.g., regression coefficients, p-values). The percentage of 
datasets with statistically significant effects (i.e., p<.05) for a given hypothesis provides a simulation-based 
estimate of power for this hypothesis. A number of simulation runs were conducted varying the size of the 
fixed-effects. These simulations revealed a sample size of 600 per treatment condition will yield power > 0.80 
given the magnitude of the treatment x time-dummy interaction coefficient was -.13 or smaller. Assuming no 
baseline differences in the outcome, this would correspond to a rate ratio of .87 at a given follow-up time point 
(i.e., a 13% decrease in PSM use for PNF intervention compared to control). Given our power to detect fairly 
small effects of the Aim 2 intervention, we would expect reasonable power to detect mediated and moderated 
effects as well. For Study 3 planned analyses of the web-based and in-person interventions, we also ran 
similar sets of simulations to assess power for varying effect sizes. We used similar estimates of random 
effects, but allowed the fixed effect of the intercept to be higher given the high risk sample and we specified a 
sample size of 100 per arm (300 total). Based on the simulations, we would expect power of .80 or higher to 
detect coefficients -.3 or smaller which corresponds to a RR of .74.  
 
Timeline:  
 
 
Limitations of the Proposed Research: We have considered and taken steps to address study 
limitations. One limitation is the use of self-report measures; we considered collateral respondents and clinical 
interviews for diagnostic purposes, but rejected these on the basis of substantial research supporting validity of 
self-report in substance use research125-129 and cost-effectiveness126. An additional limitation is related to the 
assessment of PSM misuse – while several measures for alcohol have strong reliability and validity, measures 
to document and describe PSM misuse and practices are relatively less established. However, by approaching 
assessment of practices related to the use of PSM in multiple ways, our study will appropriately capture use 
that is occurring and can contribute to assessment strategies/approaches. Although a potential limitation would 
be related to a small sample size (due to not meeting recruitment or retention targets), we are confident we can 
recruit at least 50% of initial contacts. Steps to improve recruitment and retention of representative samples, 
already proven effective in other studies across members of the research team, include compensation and 
maintenance of updated addresses. Although use of the internet for data collection may pose limitations, we 
have found no difference between web- and paper measures in prior research130. Despite limitations, the 
proposed research is a novel intervention to fill a gap in a high risk population. Results can be applied on 
campuses wishing to use effective, brief and inexpensive interventions to prevent and reduce PSM misuse. 
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STUDY PREPARATION / DISSEMINATION
HIRE & TRAIN STAFF
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