Professional Documents
Culture Documents
HSC 625 Nih Final Proposal
HSC 625 Nih Final Proposal
Lilian Ledesma, Andrea Luna, Ryan Maganini, Chris Smith, Gabriel Velazquez, Tony
Viramontes
May 4, 2023
1
A. SIGNIFICANCE
Background
The seventh leading risk factor for preventable disability & premature death worldwide is
alcohol misuse (National Institute on Alcohol Abuse and Alcoholism, 2023). In the U.S. alcohol
misuse is a major public health issue as 17% of all U.S. adults engage in alcohol misuse behavior
(CDC, 2022a). Alcohol misuse is defined as a pattern of alcohol consumption that limits an
individual's ability to control their own drinking and the behavior continues despite causing
problems for the individual (Mayo Clinic, 2022). The economic burden of alcohol misuse in
2010 was 249 billion, of which 35 billion directly impacted California (CDC, 2022a). Alcohol
misuse caused on average 3.6 million years of potential life lost each year and was responsible
for more than 140,000 deaths from 2015-2019 (CDC, 2022a). Technological advancements in
tablets and smart mobile phones have paved the way for a new field of interventions (mHealth)
to help manage chronic conditions such as alcohol misuse disorders (AUDs) and general
substance use disorders (SUDs). However, to date there is limited research of mHealth
interventions for SUDs among veterans. Research focusing specifically on alcohol misuse
disorders among veterans utilizing these new technologies is even scarcer. Utilization of mHealth
technology has the potential to revolutionize public health by directly delivering interventions to
reach and underserved populations that are disproportionately affected, like our military veterans.
With death counts on par with war and exorbitant economic impacts as a result of alcohol
misuse, it is imperative to investigate the efficacy of mHealth applications for alcohol misuse and
add to the overall body of public health knowledge.
2
(CDC, 2022b). All of these chronic conditions are further exacerbated by the fact that alcohol
misuse increases the likelihood of illness by weakening the body's immune system and its ability
to fight off illness (CDC, 2022b). Additionally, there are long term cognitive impacts to
memory, ability to learn and links to dementia (CDC, 2022b). Mental health disorders including
anxiety, depression, psychosis and antisocial behaviors are also linked to alcohol misuse (CDC,
2022b). Alcohol misuse is linked to problematic behaviors that can lead to unemployment, job
related problems and general family or social issues (CDC, 2022b). Alcohol misuse leads to
dependence on alcohol and other substances (CDC, 2022b). Lastly, alcohol misuse can lead to
permanent disability or death (National Institute on Alcohol Abuse and Alcoholism, 2023)
3
veteran population (Teeters et al., 2017). Homelessness, suicidal ideation/self-harm,
unemployment and hardships adapting to civilian life are also negative effects which motivate
veterans to resort as a means of coping (Alcohol Rehab Guide, 2022). Additionally, veterans may
feel alcohol consumption is part of their culture and is consumed as a means to bond (social
reward) with other fellow veterans and service members (American Addiction Centers, 2023).
Society may be inadvertently contributing to this particular motive because discounts for
veterans are seen as a positive gesture and many establishments that provide alcohol offer
discounts to military members (American Addiction Centers, 2023).
The method of the intervention will be a mobile-based application for military veterans,
ages 21-29 in regards to their alcohol consumption. This population has reported several
restrictions to seeking care such as being perceived as weak for seeking help as well as logistical
barriers like intensive paperwork, lack of time and traveling far to treatment facilities (Malte et
al., 2021). A potential way to alleviate the burden military veterans are experiencing seeking care
could be through mobile applications due to them being delivered through smartphones. Mobile
technology has become readily available and for this reason smartphones can be the solution to
address the barriers military veterans are facing (Malt et al., 2021). Mobile-based apps can
deliver alcohol interventions to individuals in their natural setting and timely matter to make
them feel at ease when receiving a mobile based intervention. Another advantage of using a
mobile application is individuals having a sense of anonymity to reduce the perceived stigma
associated with face-to-face interventions (Williamson et al., 2022). According to research,
digital interventions can reduce alcohol consumption by up to three standard drink units per
week on average when compared to a control group (Williamson et al., 2022). Growing evidence
suggests mobile-based applications should implement personalized push notifications to ensure
high levels of active engagement from users. For instance, these types of notifications can
suggest alternate drinking behaviors, provide feedback on goal progress and a drink diary
(Williamson et al., 2022). This proposal has numerous effects on current preventative measures.
The VA Office of Rural Health estimates that 3.4 million rural veterans make up the total number
of veterans enrolled in the VA health care system (Teeters et al., 2017). Given that the
intervention will be conducted using a mobile application, this might serve as a way to improve
access to services to military veterans in rural areas that existing interventions can adopt.
B. INNOVATION
Mobile health applications and substance use
Mobile health (mHealth) applications are becoming increasingly popular tools in treating
and identifying SUDs (substance use disorders); however, there is a lack of research focused on
the effectiveness of these applications in helping military veterans who are struggling with
alcohol misuse (Malte et al., 2021). This presents an opportunity to leverage this new technology
to deliver tailored interventions for this population, help fill gaps in research, and provide
valuable insights into alcohol misuse among military veterans. To our knowledge, there is a void
in mHealth interventions delivered specifically for alcohol misuse, as the FDA has approved
only two mHealth applications for SUDs: reSET, which was developed for all SUDs, and
reSET-O, which was developed specifically for opioids. Furthermore, despite evidence indicating
mHealth applications are acceptable and effective methods of intervention delivery, research on
mHealth interventions specifically for alcohol misuse among hard-to-reach populations, such as
military veterans, is lacking. To date only one study was conducted in U.S. veterans of this topic
in 2021 (Blonigen et al., 2020) with a very limited sample size.
4
The COVID-19 Pandemic, Telehealth, and the Future of Healthcare
Healthcare services are more commonly being conducted virtually through telehealth
services and other technology, such as mHealth applications, for most medical disciplines,
including addiction medicine, in the United States (Giacalone, 2022). Thus, given the current and
future state of healthcare services in the United States, efficacious mHealth application-based
services and interventions are needed to adapt to an increasingly digital world. Our proposed
mHealth application-based intervention would provide real-time behavior management, which
cannot be achieved through traditional in-person encounters. Moreover, this mHealth
application-based intervention would circumvent various barriers to accessing healthcare
services (e.g., cost, transportation, and health insurance coverage) and only require a smartphone
to access. Use of the mHealth application can be done discreetly, quickly, and easily, which is
helpful in mitigating stigma associated with alcohol misuse.
Addressing Comorbidities
Unlike traditional substance use interventions, which may only address substance use,
this mHealth application will link co-occurring mental health outcomes commonly experienced
by military veterans (i.e., PTSD, anxiety, depression, etc.) with alcohol misuse. Veterans
diagnosed with post-traumatic stress disorder (PTSD) are 3 times more likely to abuse alcohol
use, which highlights the importance of including mental health as part of the intervention
process (Simpson et al., 2021). As a result, this mobile app will use an innovative approach to
address substance abuse by integrating evidence-based mental health practices into its
framework. Since there currently are only two, FDA-approved mobile app treatments currently
available to treat substance use problems, this app aims to reshape the digital health landscape,
by being one of the first FDA-approved mHealth interventions specifically aimed at treating
alcohol misuse among young, military veterans (Sweeney et al., 2022).
5
and app use, which in turn can help cater more personalized, customizable, and effective
treatment for users. For example, data analytics can record data points indicating when, how
often, and where a user is drinking (based on location tracking permitted by user consent).
Moreover, this mHealth application can help determine indicators or factors that influence
alcohol consumption behavior of a user across time, allowing health care specialists to “see” a
user’s drinking consumption habits in real time. For a population that is severely understudied,
capturing and having access to continuous use data is crucial for informing other
related-interventions aimed at reducing alcohol use among military veterans. Future iterations of
the mHealth application could be paired with digital coasters containing sensors that will alert
individuals when they are approaching the 5 drink limit or the personal goal they’ve set
themselves.
C. APPROACH
Goals and Objectives: The overall goal of the proposed Drinks-Re-Al study is to reduce alcohol
consumption among young military veterans ages 21-29 years old by adapting and implementing
an innovative mHealth application-based intervention to decrease alcohol consumption. Table 1
outlines the study’s goals and objectives.
Obj. 3 To decrease the average daily alcohol consumption from pre- to post- intervention.
Goal 2: To evaluate the efficacy of the DrinksRation mobile application to deliver brief
interventions around alcohol misuse.
Obj. 4 To assess changes in attitudes, subjective norms, and perceived behavioral control.
Strategy
The Drinks-Re-Al intervention will use a one-group study design with repeated measures
(baseline, 3-month, and 6-month) to test the efficacy of an mHealth application intervention in
reducing heavy alcohol consumption for young military veterans. 160 participants will be
recruited in partnership with the Tibor Rubin VA Medical Center; however, assuming 20%
attrition, a minimum of 128 participants are expected to complete the intervention. Inclusion
criteria includes: 1) Veteran status; 2) between ages 21-29 years old; 3) Alcohol Use Disorders
Identification Test (AUDIT) score ≥ 8 (as an assessment of high risk drinking). Exclusion criteria
includes: (1) active military or reserve; and (2) lack of access to a smartphone device.
6
Theoretical Framework
Multiple factors influence the decision making process for military veterans in regards to
alcohol consumption including socioeconomic factors, environmental factors, perceived
weakness for seeking help, mental health and barriers to access (Young et al,. 2018). Therefore,
research around this population is needed to understand the importance of how addressing
personal beliefs impacts behavior change. Our intervention is based on the Theory of Planned
Behavior which looks at the attitudes, subjective norms and perceived behavioral control that
influence the decision making process of an individual that manifests in behaviors. The
intervention will use harm reduction strategies that align with the Perceived Behavioral Control
construct of the TPB. Harm reduction approaches will aim to mitigate the consequences of
alcohol misuse. Furthermore, research shows that harm reduction approaches may be effective in
diminishing heavy drinking occurrence (Smith-Bernardin et al., 2022).
Methodology
This research project will engage young military veterans (ages 21-29 years old), over a
span of six months, in an mHealth intervention delivered through the DrinksRation mobile
application. The application will be tailored to this intervention by a website developer, to
include personalized messaging based on constructs of the Theory of Planned Behavior (TPB).
Study participants will be asked to log their alcohol consumption daily, in real-time, through the
DrinksRation mobile application. Personalized app notifications will be prompted based on the
number of drinks reported in a given time-period with a focus on harm reduction using TPB
constructs, for example, 3 drinks in <60 minutes may prompt a message stating “you’re in
control, drink water, and step away for a moment.” Study participants will also receive resources
through the DrinksRation app including educational resources on high risk drinking, resources
available for healthy coping strategies, and short skill-based videos on alcohol-refusal tactics in
social settings. Participants will be prompted with survey questions related to TPB constructs
prior to being enrolled in the study (baseline), at 3 months, and at the conclusion of the study.
These surveys will focus on the participants' perceived attitudes and behaviors during that
specific moment in time. The surveys will allow us to analyze the overall effectiveness of
TPB-informed intervention during a six month period by measuring the impact of the
interventions on alcohol consumption among participants over time. Participants will also
receive gift cards incentives to ensure continued participation.
Analysis
Project evaluation will be ongoing, based on process and outcome measures using
quantitative data. A website developer will tailor the application to our specific priority
population and application analytics will be synthesized bi-annually by a data evaluator. Analysis
will include data collected from daily reported alcohol consumption and the three surveys. We
hypothesize that the use of the DrinksRation mobile application to provide brief interventions
related to alcohol use guided by the theory of planned behavior will significantly reduce
self-reported alcohol misuse among a sample of young military veterans ages 21-29.
7
References
American Addiction Centers. (2023). Alcohol abuse among veterans - alcoholism in active
service members. https://americanaddictioncenters.org/veterans/alcoholism
Centers for Disease Control and Prevention. (2022a). Data on excessive drinking.
https://www.cdc.gov/alcohol/data-stats.htm
Centers for Disease Control and Prevention. (2022b). Drinking too much alcohol can harm your
health. learn the facts. https://www.cdc.gov/alcohol/fact-sheets/alcohol-use.htm
Dulin, P.L., Gonzalez, V.M., & Campbell K. (2014). Results of a pilot test of a self-administered
smartphone-based treatment system for alcohol use disorders: Usability and early
outcomes. Substance Abuse, 35(2), 168-175.
https://doi.org/10.1080/08897077.2013.821437
Gajecki, M., Berman, A. H., Sinadinovic, K., Rosendahl, I., & Andersson, C. (2014). Mobile
phone brief intervention applications for risky alcohol use among university students: A
randomized controlled study. Addiction Science & Clinical Practice, 9(1).
https://doi.org/10.1186/1940-0640-9-11
Giacalone, A., Marin, L., Febbi, M., Franchi, T., & Tovani-Palone, M. R. (2022). eHealth,
telehealth, and telemedicine in the management of the COVID-19 pandemic and beyond:
Lessons learned and future perspectives. World Journal of Clinical Cases, 10(8),
2363–2368. https://doi.org/10.12998/wjcc.v10.i8.2363
Lin, L. A., Bonar, E. E., Zhang, L., Girard, R., & Coughlin, L. N. (2022). Alcohol-involved
overdose deaths in US veterans. Drug and alcohol dependence, 230, 109196.
https://doi.org/10.1016/j.drugalcdep.2021.109196
Malte, C.A., Dublin, P.L., Baer, J.S., Fortney, J.C., Danner, A.N., Lott, A.M.K., & Hawkins, E.J.
(2021). Usability and acceptability of a mobile app for the self-management of alcohol
misuse among veterans (step away): Pilot cohort study. JMIR Mhealth Uhealth, 9(4).
https://doi.org/10.2196/25927
Miller, S., Pedersen, E. R., & Marshall, G. N. (2016). Combat experience and veterans' problem
drinking: Exploring the roles of PTSD, coping, and stigma. RAND Corporation.
https://www.rand.org/pubs/external_publications/EP66756.html
National Center for PTSD . (2018). For Veterans and Families: Understanding PTSD and
Substance Use. https://www.ptsd.va.gov/publications/print/
National Institute on Alcohol Abuse and Alcoholism. (2023). Understanding alcohol's impact on
health. U.S. Department of Health and Human Services.
8
https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/understanding-alcohol-
impact-health
National Institutes of Health. (2022). Substance use and military life drugfacts.
https://nida.nih.gov/publications/drugfacts/substance-use-military-life
NIDA. 2019, October 23. Substance Use and Military Life DrugFacts.
https://nida.nih.gov/publications/drugfacts/substance-use-military-life
Panza, K. E., Kline, A. C., Na, P. J., Potenza, M. N., Norman, S. B., & Pietrzak, R. H. (2022).
Epidemiology of DSM-5 alcohol use disorder in U.S. military veterans: Results from the
National Health and Resilience in Veterans Study. Drug and alcohol dependence, 231,
109240. https://doi.org/10.1016/j.drugalcdep.2021.109240
Simpson, T.L., Goldberg, S.B., Louden, D.K.N., Blakey, S.M., Hawn, S.E., Lott, A., Browne,
K.C., Lehavot, K., & Kaysen, D. (2021). Efficacy and acceptability of interventions of
co-occurring PTSD and SUD: A meta-analysis. Journal of Anxiety Disorders, 84.
https://doi.org/10.1016/j.janxdis.2021.102490
Smith-Bernardin, S. M., Suen, L. W., Barr-Walker, J., Cuervo, I. A., & Handley, M. A. (2022).
Scoping review of managed alcohol programs. Harm reduction journal, 19(1), 1-27.
Straus, E., Norman, S. B., & Pietrzak, R. H. (2020). Determinants of new-onset alcohol use
disorder in US military veterans: Results from the national health and resilience in
veterans study. Addictive Behaviors, 105, 106313.
https://doi.org/10.1016/j.addbeh.2020.106313
Substance Abuse and Mental Health Services Administration. (2020). 2019 National Survey on
Drug Use and Health: Veteran Adults.
https://www.samhsa.gov/data/sites/default/files/reports/rpt31103/2019NSDUH-Veteran/V
eterans%202019%20NSDUH.pdf
Sweeney, M. M., Holtyn, A. F., Stitzer, M. L., & Gastfriend, D. R. (2022). Practical Technology
for Expanding and Improving Substance Use Disorder Treatment. Psychiatric Clinics of
North America, 45(3), 515–528. https://doi.org/10.1016/j.psc.2022.05.006
Teeters, J. B., Lancaster, C. L., Brown, D. G., & Back, S. E. (2017). Substance use disorders in
military veterans: prevalence and treatment challenges. Substance abuse and
rehabilitation, 8, 69–77. https://doi.org/10.2147/SAR.S116720
Williamson, C., White, K., Rona, R.J., Simms, A., Fear, N.T., Goodwin, L, Murphy, D., &
Leightley, D. (2022). Smartphone-based alcohol interventions: A systemic review on the
role of notifications in changing behaviors toward alcohol. Substance Abuse, 43(1),
1231-1244.
Young, C. M., Pedersen, E. R., Pearson, A. D., & Neighbors, C. (2018). Drinking to cope
moderates the efficacy of changing veteran drinking norms as a strategy for reducing
drinking and alcohol-related problems among U.S. veterans. Psychology of Addictive
9
Behaviors: Journal of the Society of Psychologists in Addictive Behaviors, 32(2),
213–223. https://doi.org/10.1037/adb0000347
Zhao, J., Freeman, B., & Li, M. (2016). Can mobile phone apps influence people’s health
behavior change? An evidence review. Journal of Medical Internet Research, 18(11),
e287. https://doi.org/10.2196/jmir.5692
10
Drinks-Re-Al:
An mHealth Intervention to Reduce Alcohol
Misuse Among Military Veterans, Age 21-29
A. SIGNIFICANCE
B. INNOVATION
C. APPROACH
Funding Opportunity Specifics
● Notice of Special Interest (NOSI): Issued by National Institute on
Alcohol Abuse and Alcoholism
● mHealth Intervention
○ Limited research of mHealth interventions for veterans
○ More accessible to underserved populations
Prevalence of Alcohol Misuse
Alcohol misuse is the most common form of substance abuse among
military veterans.
Obj. 3 To decrease the average daily alcohol consumption from pre- to post- intervention.
Goal 2: To evaluate the efficacy of the DrinksRation mobile application to deliver brief interventions
around alcohol misuse.
Obj. 4 To assess changes in attitudes, subjective norms, and perceived behavioral control.
Receive resources
American Addiction Centers. (2023). Alcohol abuse among veterans - alcoholism in active service members.
https://americanaddictioncenters.org/veterans/alcoholism
Centers for Disease Control and Prevention. (2022). Drinking too much alcohol can harm your health. learn the facts.
https://www.cdc.gov/alcohol/fact-sheets/alcohol-use.htm
Dulin, P.L., Gonzalez, V.M., & Campbell K. (2014). Results of a pilot test of a self-administered smartphone-based treatment system
for alcohol use disorders: Usability and early outcomes. Substance Abuse, 35(2), 168-175.
https://doi.org/10.1080/08897077.2013.821437
Gajecki, M., Berman, A. H., Sinadinovic, K., Rosendahl, I., & Andersson, C. (2014). Mobile phone brief intervention applications for
risky alcohol use among university students: A randomized controlled study. Addiction Science & Clinical Practice, 9(1).
https://doi.org/10.1186/1940-0640-9-11
Giacalone, A., Marin, L., Febbi, M., Franchi, T., & Tovani-Palone, M. R. (2022). eHealth, telehealth, and telemedicine in the
management of the COVID-19 pandemic and beyond: Lessons learned and future perspectives. World Journal of Clinical
Cases, 10(8), 2363–2368. https://doi.org/10.12998/wjcc.v10.i8.2363
References - cont’d
Lin, L. A., Bonar, E. E., Zhang, L., Girard, R., & Coughlin, L. N. (2022). Alcohol-involved overdose deaths in US veterans.
Drug and alcohol dependence, 230, 109196. https://doi.org/10.1016/j.drugalcdep.2021.109196
Malte, C.A., Dublin, P.L., Baer, J.S., Fortney, J.C., Danner, A.N., Lott, A.M.K., & Hawkins, E.J. (2021). Usability and
acceptability of a mobile app for the self-management of alcohol misuse among veterans (step away): Pilot cohort
study. JMIR Mhealth Uhealth, 9(4). https://doi.org/10.2196/25927
Miller, S., Pedersen, E. R., & Marshall, G. N. (2016). Combat experience and veterans' problem drinking: Exploring the
roles of PTSD, coping, and stigma. RAND Corporation.
https://www.rand.org/pubs/external_publications/EP66756.html
National Center for PTSD . (2018). For Veterans and Families: Understanding PTSD and Substance Use.
https://www.ptsd.va.gov/publications/print/
National Institute on Alcohol Abuse and Alcoholism. (2023). Understanding alcohol's impact on health. U.S. Department of
Health and Human Services.
https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/understanding-alcohol-impact-health
National Institutes of Health. (2022). Substance use and military life drugfacts.
https://nida.nih.gov/publications/drugfacts/substance-use-military-life
References - cont’d
Panza, K. E., Kline, A. C., Na, P. J., Potenza, M. N., Norman, S. B., & Pietrzak, R. H. (2022). Epidemiology of DSM-5
alcohol use disorder in U.S. military veterans: Results from the National Health and Resilience in Veterans Study.
Drug and alcohol dependence, 231, 109240. https://doi.org/10.1016/j.drugalcdep.2021.109240
Simpson, T.L., Goldberg, S.B., Louden, D.K.N., Blakey, S.M., Hawn, S.E., Lott, A., Browne, K.C., Lehavot, K., & Kaysen,
D. (2021). Efficacy and acceptability of interventions of co-occurring PTSD and SUD: A meta-analysis. Journal of
Anxiety Disorders, 84. https://doi.org/10.1016/j.janxdis.2021.102490
Smith-Bernardin, S. M., Suen, L. W., Barr-Walker, J., Cuervo, I. A., & Handley, M. A. (2022). Scoping review of managed
alcohol programs. Harm reduction journal, 19(1), 1-27.
Straus, E., Norman, S. B., & Pietrzak, R. H. (2020). Determinants of new-onset alcohol use disorder in US military
veterans: Results from the national health and resilience in veterans study. Addictive Behaviors, 105, 106313.
https://doi.org/10.1016/j.addbeh.2020.106313
Substance Abuse and Mental Health Services Administration. (2020). 2019 National Survey on Drug Use and Health:
Veteran Adults.
https://www.samhsa.gov/data/sites/default/files/reports/rpt31103/2019NSDUH-Veteran/Veterans%202019%20NSD
UH.pdf
References - cont’d
Sweeney, M. M., Holtyn, A. F., Stitzer, M. L., & Gastfriend, D. R. (2022). Practical Technology
for Expanding and Improving Substance Use Disorder Treatment. Psychiatric Clinics of North America, 45(3),
515–528. https://doi.org/10.1016/j.psc.2022.05.006
Teeters, J. B., Lancaster, C. L., Brown, D. G., & Back, S. E. (2017). Substance use disorders in military veterans: prevalence
and treatment challenges. Substance abuse and rehabilitation, 8, 69–77. https://doi.org/10.2147/SAR.S116720
Williamson, C., White, K., Rona, R.J., Simms, A., Fear, N.T., Goodwin, L, Murphy, D., & Leightley, D. (2022).
Smartphone-based alcohol interventions: A systemic review on the role of notifications in changing behaviors
toward alcohol. Substance Abuse, 43(1), 1231-1244.
Young, C. M., Pedersen, E. R., Pearson, A. D., & Neighbors, C. (2018). Drinking to cope moderates the efficacy of
changing veteran drinking norms as a strategy for reducing drinking and alcohol-related problems among U.S.
veterans. Psychology of Addictive Behaviors: Journal of the Society of Psychologists in Addictive Behaviors, 32(2),
213–223. https://doi.org/10.1037/adb0000347
Zhao, J., Freeman, B., & Li, M. (2016). Can mobile phone apps influence people’s health behavior change? An evidence
review. Journal of Medical Internet Research, 18(11), e287. https://doi.org/10.2196/jmir.5692
Key Informant Interview Narrative
of the American Society of Addiction Medicine. Her expertise stems from decades working in
behavioral health, primary care, and behavioral health specialty care integration. Currently, Dr.
Robinson works as the Principal at Health Management Associates (HMA), a national research
and consulting firm that focuses on publicly funded healthcare. She has previously served as
director of the Alcohol and Drug Treatment Program at the San Diego Veterans Administration
(VA). Where she oversaw screening, brief intervention, referral, assessment, level of care
determination, initiated medications for addiction treatment (MAT), and expanded access to
educational materials for alcohol use disorders, opioid use disorders, pain management and
treatment of insomnia. As a certified addiction medicine specialist, Dr. Robinson has experience
in research, prevention, intervention, screening, treatment of addiction, and the ability to identify
The program decided that interviewing a professional with experience working with
veterans and learning their expertise was crucial. Dr. Robinson gave valuable insight into
cultural norms and perceptions of veterans who use alcohol which can guide the personalized
messaging used in the Re-Al mobile application. She furthered the research team's
understanding of the typical stresses experienced by military veterans. Dr. Robinson spoke to
us about other interventions that she is familiar with, which prompted us to consider what made
those interventions effective and any difficulties or obstacles the team might encounter when
putting this program into practice. Finally, it was a great opportunity to network with an expert
2. What are some cultural norms or perceptions of alcohol use or misuse among young
military veterans?
An important aspect to consider when working with young military veterans is the heavy
drinking culture. Drinking is an accepted method of coping within the veteran community and
it begins as a means of coping with stress and/or physical injury as a result of military
experience. An important component of drinking culture is it begins early in military service
with peer pressure in order to gain acceptance into groups and is seen as an acceptable
coping method to deal with stressors of military lifestyle and carries into veteran status.
3. What are some common stressors that young military veterans are experiencing?
Young military veterans most commonly experience housing instability, social isolation, job
insecurity, post-traumatic stress disorder, depression, anxiety, substance use misuse and
suicide risk. Unfortunately, many veterans will suffer from more than one of these conditions
when returning home from active duty. Co-occurring stressors and the stigmas sometimes
associated with them need to be considered when developing effective intervention.
4. What are some, if any, interventions that you are familiar with to reduce alcohol use or
misuse among young military veterans? Motivational Interviewing, Cognitive
Behavior Therapy
She recommended that the team review the SAMHSA website. The website offers a lot
of helpful information and gathers a lot of primary data for an adult veteran population
national survey on drug use. There are also a lot of referrals for other resources to
connect veterans to mental health and substance use care. Additionally, it could be
helpful to research previous interventions that have worked well for veterans who abuse
alcohol.
5. Is there anything else you think our team should incorporate into our research study
that would be beneficial for this grant?
Yes, consider the role of family in overcoming addiction and also how a mobile application
can be expanded to other modes of communication.
BUDGET JUSTIFICATION: Drinks-Re-Al
2. Program Evaluator, Luna Fregoso MPH. ($26,260) Total effort = (1.8 months of
calendar year of project period) Ms. Fregoso will plan and manage all aspects of
program evaluations, including methods design, data collection, data analysis, and
reporting, developing qualitative and quantitative methods and instruments. Summarize
findings in written reports and presentations, including creativity in data messaging,
graphs and infographics.
C.FRINGE BENEFITS. ($68,698) Employee benefits are estimated using the composite benefit
rate figures agreed upon by the California State University, Long Beach Research Foundation
Composite Fringe Benefit Rates (CFBR) and the California State University System-wide
Administration based on the Collaborative Bargaining Agreements (CBA). The rates are based
on the employee groupings. The composite benefit rates used on employees in this proposal
are:
● Faculty: 49.98% Buyout/Release/Reimbursed And/Or 8.85% Add’l/Summer/Overload
● CSULB: 58.61%-MPP / 45.44%-Lecturers / 50.85%-Librarians / 61.63%-Staff / 8.85%-
Add’l Employment
● Foundation: 10.68% (0%-74% Time Base/Temp) / 42.45% (50%-70% Time Base/Part-
Time) / 64.45% (75%-100% Time Base/Full-Time)
● Students: 10.68% (Undergraduate and Graduate)
OTHER DIRECT COSTS. ($19,280) Items listed under this category were put together
with much consideration and thought. Items are not only reasonable but also needed to
successfully accomplish the task as stated on the research plan.
G7:Participant Incentives: ($7,680) 128 participants will get three $20 gift cards, one
after completion of each evaluation activity (three total evaluation activities).
J.TOTAL INDIRECT COST: ($53,826) OFF CAMPUS RATE CSULB Research Foundation’s
Off-Campus DHHS federally negotiated rate of 26% effective as of 07/01/2018-06/30/2021
(renewal in review/pending) on projects sponsored through government grants or per programs
guidelines. The MTDC base consists of all salaries and wages, benefits, supplies, services,
travel, and the first $25,000 of each subaward. Equipment, student fees/scholarship, off site
facility rentals, and the portion of each subaward more than $25,000 are excluded from the
MTDC calculations.
Cayuse SP #
COST MATCH
TOTALS
CSULB PI/PD: Chris Smith, PhD
Dept. & College:
Project Title: Drinks-Re-Al *IF APPLICABLE, Information
will be carryforward from the
CSULB Sponsor: "Cost Match Worksheet" Tab
Flow through Agency: below
Project Periods:
*Faculty Salary includes a 3.5% escalator and Staff/Students at 2% escalator per year starting in year 2
Role Name: * Contact PAS or ASM for Faculty Salaries
PI/PD: Chris Smith, PhD (Buyout/Release OR Reimbursed) $100,000 $11,111) 1.20 Mo $13,333) 1.20 Mo $13,800) $27,133) $0)
PI/PD: Chris Smith, PhD (Add'l Pay OR Summer Effort) $0 $0) 0.00 Mo $0) 0.00 Mo $0) $0) $0)
Employee Type
* PI/PD: Insert Name CSULB/MPP 12 (e.g., 9 or 12 Months) Reimbursed $0 $0) 0.00 Mo $0) 0.00 Mo $0) $0) $0)
CSULB/Fnd Add'l Pay $0 $0) 0.00 Mo $0) 0.00 Mo $0) $0) $0)
* PI/PD: Insert Name CSULB/ Fnd $0 $0) 0.00 Mo $0) 0.00 Mo $0) $0)
2. Co-I/PI: Insert Name (Buyout/Release OR Reimbursed) $0 $0) 0.00 Mo $0) 0.00 Mo $0) $0) $0)
Co-I/PI: Insert Name (Add'l Pay OR Summer Effort) $0 $0) 0.00 Mo $0) 0.00 Mo $0) $0) $0)
3. Co-I/PI: Insert Name (Buyout/Release OR Reimbursed) $0 $0) 0.00 Mo $0) 0.00 Mo $0) $0) $0)
Co-I/PI: Insert Name (Add'l Pay OR Summer Effort) $0 $0) 0.00 Mo $0) 0.00 Mo $0) $0) $0)
4. Co-I/PI: Insert Name (Buyout/Release OR Reimbursed) $0 $0) 0.00 Mo $0) 0.00 Mo $0) $0) $0)
Co-I/PI: Insert Name (Add'l Pay OR Summer Effort) $0 $0) 0.00 Mo $0) 0.00 Mo $0) $0) $0)
B. OTHER PERSONNEL: CSULB Staff, Foundation, & Students Only Annual Salary Base Rate
5. TBD Insert Name CSULB/FDN $0 $0) 0.00 Mo $0) 0.00 Mo $0) $0) $0)
6. TBD Insert Name CSULB/FDN $0 $0) 0.00 Mo $0) 0.00 Mo $0) $0) $0)
Pay Rate:
1. Graduate Student(s) Year 1 Year 2 Year 3 Year 4 Year 5 ($ - )
Number of Students:
FDN <50% 0 0 0 0 0
Total Student Hrs.: 0 0 0 0 0 TB or temp $0 $0) 0.00 Mo $0 0.00 Mo $0) $0) $0)
Pay Rate:
2. Undergraduate Student(s) Year 1 Year 2 Year 3 Year 4 Year 5 ($ - )
Number of Students:
FDN <50% 0 0 0 0 0
0 0 0 0 0 TB or temp
Total Student Hrs.: $0 $0) 0.00 Mo $0 0.00 Mo $0) $0) $0)
A & B. Salary TOTAL: $58,833 $60,210 $119,043) $0)
C. FRINGE BENEFITS
PI/PD: Chris Smith, PhD (Buyout/Release OR Reimbursed) 49.98% $6,664) $6,897) $13,561) $0)
PI/PD: Chris Smith, PhD (Add'l Pay OR Summer Effort) 8.85% $0) $0) $0) $0)
* PI/PD: Insert Name CSULB/MPP Reimbursed 58.61% $0) $0) $0) $0)
$0)
CSULB/Fnd Add'l Pay 10.68% $0) $0) $0) $0)
* PI/PD: Insert Name CSULB/Fnd 64.45% $0) $0)
$0) $0) $0)
Cayuse SP #
COST MATCH
TOTALS
CSULB PI/PD: Chris Smith, PhD
Dept. & College:
Project Title: Drinks-Re-Al *IF APPLICABLE, Information
will be carryforward from the
CSULB Sponsor: "Cost Match Worksheet" Tab
Flow through Agency: below
Project Periods:
Section A, B, C. (Salaries & Fringe Benefits) TOTAL: (1) $92,793) (2) $94,949) $187,741) $0)
D. Equipment: Unit cost =/> $5,000 - Not subject to F&A charges - Quote is Mandatory
1. $0) $0) $0) $0)
2. $0) $0) $0) $0)
3. $0) $0) $0) $0)
4. $0) $0) $0) $0)
5. $0) $0) $0) $0)
Applicable Fees Below & Quote are Mandatory
Shipping and Handing Fees: $0) $0) $0) $0)
Insurance Fees: $0) $0) $0) $0)
Vendor Sales Tax: $0) $0) $0) $0)
Sales Tax (10.25% Long Beach Sales Tax): $0) $0) $0) $0)
D. Equipment TOTAL: (1) $0) (2) $0) $0) $0)
E. Travel:
For Quote: http://www.defensetravel.dod.mil/site/perdiemCalc.cfm
1. Domestic (Air/Hotel/Transportation): $0) $0) $0) $0)
2. Domestic (Mileage): $0) $0) $0) $0)
3. Foreign Travel: $0) $0) $0) $0)
*** Mandatory Foreign Travel Insurance (FTIP): https://www.csulb.edu/undergraduate-studies/undergraduate-studies/travel-guidelines $0) $0) $0) $0)
*Questions contact Risk Management (562) 985-2396 or FM-RiskManagement@csulb.edu
E. Travel TOTAL: (1) $0) (2) $0) $0) $0)
F.Student (Participate) Support: CSULB Student(s) only / Reported & Managed by the Finacial Aid Office - Not subject to F&A charges
Estimate # of Participant(s): 4 Type of Student(s): Graduate e.g, Undergrad / Graduate
*Use latest CSULB Fees on https://www.csulb.edu/student-records/tuition-and-fees
1. Tuition Fees (Scholarship): $0 $0 $0) $0)
2. Travel: $0 $0 $0) $0)
3. Subsistence Allowance: $0 $0 $0) $0)
4. Other: Stipend $7,040 $7,040 $14,080) $0)
F. Participant Support TOTAL: (1) $7,040) (2) $7,040) $14,080) $0)
G . OTHER DIRECT COSTS: e.g., type of office, field or lab supplies
G1. Materials and Supplies:
1. iPad tablets (x3) $1,500) $0) $1,500) $0)
2. External harddrive $100) $0) $100) $0)
3. Laptop (x2) $1,700) $0) $1,700) $0)
4. Promotion materials $2,500) $2,500) $5,000) $0)
5. Canva Pro for Teams $150) $150) $300) $0)
6. $0) $0) $0) $0)
G1. Materials & Supplies TOTAL: (1) $5,950) (2) $2,650) $8,600) $0)
G2. Publication(s): 1. $0) $0) $0) $0)
2. $0) $0) $0)
G2. Publicaiton(s) TOTAL: (1) $0) (2) $0) $0)
G3. Consultant(s): Non-CSULB/CSU employee Only. Will need to Provide Name of Individual & Company Name
1. Gabriel Velazquez- Application developer/ Tech support from DrinksRation $2,000) $1,000) $3,000) $0)
2. $0) $0) $0) $0)
3. $0) $0) $0) $0)
G3. Consultant TOTAL: (1) $2,000) (2) $1,000) $3,000) $0)
(INTERNAL)
ULAS**
Cayuse SP #
COST MATCH
TOTALS
CSULB PI/PD: Chris Smith, PhD
Dept. & College:
Project Title: Drinks-Re-Al *IF APPLICABLE, Information
will be carryforward from the
CSULB Sponsor: "Cost Match Worksheet" Tab
Flow through Agency: below
Project Periods:
J. 1. TOTAL INDIRECT COSTS (F&A): CSULB's Federally Negotiated Rates (click on drop-down menu for different rates) 26.00% (1) $28,190) (2) $25,636) $53,826) $0)
2. OTHER TOTAL INDIRECT COSTS (F&A): Per RFA & with Approval from ORED AVP & when applicable, PI/PD's Dept/College 0% (1) $0) (2) $0) $0) $0)
L. TOTAL DIRECT & INDIRECT COSTS: (1) $143,653) (2) $131,274) $274,927) $0)
Revised Jan2023
BIOGRAPHICAL SKETCH
Provide the following information for the Senior/key personnel and other significant contributors.
Follow this format for each person. DO NOT EXCEED FIVE PAGES.
eRA COMMONS USER NAME (credential, e.g., agency login): California State University, Long Beach
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include
postdoctoral training and residency training if applicable. Add/delete rows as necessary.)
Completion
DEGREE
Date FIELD OF STUDY
INSTITUTION AND LOCATION (if applicable)
MM/YYYY
A. Personal Statement
The goal of our research program is to better understand how mobile applications can help military veterans in terms of
their alcohol consumption. My experience in Public Health provides a solid foundation for planning and leading
interventions. Also, I have acquired a skill set over the past three years that will enable me to conduct motivational
interviews with participants, facilitate health education and appropriate survey delivery methods. To carry out the
suggested study, our group has the necessary experience and skills to complete this proposal.
2023- Present Study Coordinator for HIV Prevention program, Bienestar Human Services Inc.
2022- Present LINK Scholar, Center for Latino Community Health
2020- Present Eat, Play, Go! Research Assistant, Center for Latino Community Health
2020-2021 Health Services Intern/Community Navigator, The LGBTQ Center Long Beach
C. Contributions to Science
Non-applicable
BIOGRAPHICAL SKETCH
Provide the following information for the Senior/key personnel and other significant contributors.
Follow this format for each person. DO NOT EXCEED FIVE PAGES.
eRA COMMONS USER NAME (credential, e.g., agency login): California State University, Long Beach
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include
postdoctoral training and residency training if applicable. Add/delete rows as necessary.)
Completion
DEGREE
Date FIELD OF STUDY
INSTITUTION AND LOCATION (if applicable)
(MM/YYYY)
A. Personal Statement
Ryan Maganini is a consultant and researcher at Health Management Associates with experience conducting community
health needs assessments, program evaluations, and landscape analyses using his qualitative and quantitative research
and data analytic skills. He is passionate about telling stories through data, analyzing epidemiological trends, and
understanding the role of social determinants of health in public health issues. Prior to joining Health Management
Associates, Ryan worked as a program and outreach coordinator for the STOP Violence Program at the Los Angeles
LGBT Center, where he conducted research, outreach and advocated for clients. While at the STOP Violence Program,
he worked on a federal grant to analyze access to social support services for LGBTQ+ identified victims of crime in Los
Angeles County. Prior to working at the Los Angeles LGBT Center, he worked on the Safe Schools Project with The
Queer Youth Task Force of Santa Cruz County, advocating for safe spaces for LGBTQ+ identified youth and developed
programming to support them. Additionally, he has developed curriculum, lead trainings, and conducted evaluations for
LGBTQ+ competency trainings for parents, staff and youth with an organization called QEDU. He is interested in using his
research experience and LGBTQ+ community health expertise to identify community needs and refine both public agency
and community led interventions and initiatives to address health inequities.
C. Contributions to Science
Not Applicable
BIOGRAPHICAL SKETCH
Provide the following information for the Senior/key personnel and other significant contributors.
Follow this format for each person. DO NOT EXCEED FIVE PAGES.
eRA COMMONS USER NAME (credential, e.g., agency login): California State University, Long Beach
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include
postdoctoral training and residency training if applicable. Add/delete rows as necessary.)
Completion
DEGREE
Date FIELD OF STUDY
INSTITUTION AND LOCATION (if applicable)
MM/YYYY
A. Personal Statement
My philosophy of public health is using acquired knowledge to improve the health communities through policy change
or intervention. Public health covers a very broad scope of health-related topics that affect where people work, play,
live. By changing health policy, improving health management and utilizing behavioral science, social science,
biostatistics and epidemiology we can take equitable public health approaches that protect the health of communities
and improve the health of populations suffering from health disparities.
C. Contributions to Science
Chris Smith M.P.H., Crystal Ojukwu M.P.H., Banafsheh Behzad Ph.D., Niloofar Bavarian Ph.D., M.P.H. (In Press).
Minimizing Substance Use Among College Students During the COVID-19 Pandemic: A Theory-Guided Optimization
Approach. California State University, Long Beach
BIOGRAPHICAL SKETCH
Provide the following information for the Senior/key personnel and other significant contributors.
Follow this format for each person. DO NOT EXCEED FIVE PAGES.
eRA COMMONS USER NAME (credential, e.g., agency login): California State University, Long Beach
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing,
include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)
DEGREE Completion
(if Date FIELD OF STUDY
INSTITUTION AND LOCATION
applicable) MM/YYYY
A. Personal Statement
As a public health professional, I aim to drive positive change and equitable opportunities to vulnerable and
underrepresented communities. More importantly, I stress the importance of closely working and collaborating
with local government agencies, organizations, and businesses. Throughout my professional and academic
experience, I’ve learned that educating communities, especially ones that are underrepresented and
disadvantaged due to barriers or resources, is a significant way to give them the necessary tools they need to
feel empowered to fight for their rights and for their health. Engaging these communities, bridging new
connections, and educating individuals about public health programs and resources are all crucial to bringing
real, impactful change.
C. Contributions to Science
Not applicable
BIOGRAPHICAL SKETCH
Provide the following information for the Senior/key personnel and other significant contributors.
Follow this format for each person. DO NOT EXCEED FIVE PAGES.
eRA COMMONS USER NAME (credential, e.g., agency login): California State University, Long Beach
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include
postdoctoral training and residency training if applicable. Add/delete rows as necessary.)
Completion
DEGREE
Date FIELD OF STUDY
INSTITUTION AND LOCATION (if applicable)
MM/YYYY
A. Personal Statement
I have more than 14 years of experience working with communities leading the program development of socially aware
health promotion programs, policy and advocacy. I was the Director of Health Programs for more than 12 years at the
LGBTQ Center in Orange County; I currently work at the City of Long Beach, City Manager's Office of Equity. I have
chaired several local and state health focused planning bodies like the HIV Integrated Plan Committee and the California
Planning Group, where I helped develop HIV prevention strategies at the state level. In 2019 I led an LGBTQ focused
tobacco prevention and cessation program advocating for policy change to ensure the safety of LGBTQ youth in Orange
County, CA. I formalized and developed the curriculum for the LGBTQ Center OC’s Cultural Competency Community
Training Program; which aims to bring equity to LGBTQ people in OC through best practices education and best
practices. I believe we all have a social responsibility to support and uplift each other. My contribution to making the world
a better place is through empathy, advocacy, policy change and education. Applying an equity lens to all my work, I
believe in developing programs that meet communities where they are, and advocate for resources to support happiness,
health and overall wellbeing.
B. Positions, Scientific Appointments, and Honors
C. Contributions to Science
Not Applicable
BIOGRAPHICAL SKETCH
Provide the following information for the Senior/key personnel and other significant contributors.
Follow this format for each person. DO NOT EXCEED FIVE PAGES.
eRA COMMONS USER NAME (credential, e.g., agency login): California State University, Long Beach
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include
postdoctoral training and residency training if applicable. Add/delete rows as necessary.)
Completion
DEGREE
Date FIELD OF STUDY
INSTITUTION AND LOCATION (if applicable)
MM/YYYY
A. Personal Statement
Andrea Luna is a Masters of Public Health Student at California State University, Long Beach. She also has a bachelors in
community health education and is highly interested in pursuing a PhD. As a graduate student Luna has enjoyed
engaging in various aspects of public health through academic and internship experiences. Luna works in conducting
research and has co-authored a peer-reviewed publication. Luna’s expertise is working with diverse Latino communities.
She has developed curriculum for obesity prevention in Latino youth, provided resources for Latina women to attain
cervical cancer screening, and facilitated health education sessions to educate community members about the dangers of
second hand smoke in multiunit housing. Her short-term goal is to work as a project manager upon graduation from the
MPH program. Her long-term goal, however, is to attain a Ph. D and become a professor, a research scientist, and a
mentor to students.
C. Contributions to Science
Roy, R. N., Bradecich, A., Dayne, N., & Luna, A. (2018). The Transition to Motherhood: The Experiences of College
Student-Parents. Journal of Family & Consumer Sciences, 110(3), 48-57.
Luna, A. BS, Garay, J. MPH, Leon Cruz, G. A., Rosales, A. A., Garcia, M. PhD, MPH (2022, March 10). The association
between television screen time and body mass index among Latina women. 34th Annual CSULB Student Research
Competition. Long Beach, California.
Roy, R. Ph. D, Dayne, N. Ed. D, Walker, A. Ph. D, Bradecich, A. Psy. D, & Luna, A. (2018, November) An Examination of
Parenting Stress Among College Fathers Attending a Hispanic Serving Institution. Nation Council on Family Relations
(NCFR) Annual Conference. San Diego, California.
Luna, A., Barahona, R. BA, Rodriguez, Y.L. MPH, Murphy, S. Ph. D & Baezconde-Garbanati, L. Ph. D (2018, July). Its
Important Its Easy Its Time: Cervical Cancer Prevention. Building Infrastructure Leading to Diversity (BUILD) Summer
Symposium. California State University, Long Beach.
Dayne, N. Ed. D, Roy, R. Ph. D, Bradecich, A. Ph. D & Luna, A. (2018, April) The Childcare Experiences and Campus
Support Services of College Students who are Parents at a 4-year Institution. American Association of Family and
Consumer Sciences, Western Region Biennial Conference. San Francisco, California.
Luna, A., Roy, R. Ph.D., Dayne, N. Ed. D., Bradecich, A. Psy. D., & Vazquez, L. (March 2018). The Role of Familial
Support on Parenting Stress among College Student-Parents. Society for Personality and Social Psychology (SPSP)
Annual Convention. Atlanta, Georgia.
Luna, A., Roy, R. Ph. D, FLE. (July 2017). Student-Parents: Experiences and Expectations of New Mothers Enrolled in
College. Building Infrastructure Leading to Diversity (BUILD) Summer Symposium. California State University, Long
Beach.
Luna, A., Vazquez, L., Roy, R. Ph. D. (May 2017). Parenthood Among College Students. Undergraduate Research
Opportunity Program (UROP) Symposium. California State University, Long Beach.
Luna, A., Ngo, C., Roy, R. Ph. D. (May 2016). Experiences of Parenthood Among College Students. Undergraduate
Research Opportunity Program (UROP) Symposium. California State University, Long Beach.
CSULB IRB Application for Administrative and Limited Review Version: 01/02/2018
Before proceeding to the application on the next page, please confirm that your research activities satisfy one of
the following criteria. Otherwise, your project may require Expedited or Standard Review. If your project involves
the use of identifiable secondary or existing data, please complete the IRB Application for Existing & Secondary
Data.
You should only fill this form out if your project involves any of the following:
❖ Normal educational practices in an educational setting. The research activities cannot adversely affect students’
opportunity to learn required educational content OR adversely affect the instructors who provide instruction.
Example: Comparing multi-media lesson plans in Fall Semester to paper-based lesson plans in Spring semester. The
same educational material is covered, only the teaching technique varies.
❖ Surveys, interviews, observation, educational test or behavioral interventions where the data collection is verbal, in
writing or recorded (audio or video) and MUST satisfy one of the following:
o Anonymous data collection (no links to identifiers such as names)
o Data collected does not place subjects at risk or harm
o Data that are identifiable, but protections are provided for confidentiality
Data collection involving children (under 18) or other vulnerable populations requires Expedited Review and
submission via the IRB Application for Expedited and Standard Review.
Example 1: Qualtrics survey to collect data on CSULB students’ study habits during finals for the purpose of a senior
thesis; whether data are collected anonymously or confidentially.
Example 2: Interviews with transgender women to understand the harassment they endure in the workplace. No
names, employers or company names are used. Pseudonyms used instead. Interviews will be audio recorded with
permission in the consent form prior to the interview.
❖ Benign behavioral interventions involving authorized deception (subjects must consent to deception prior to the
research procedures). The use of concealed deception or manipulation requires Expedited Review and submission
via the IRB Application for Expedited and Standard Review.
Example: Group activity involving a white woman in scenario 1 and a black man in scenario 2 who both demonstrate
an anger problem and subjects are surveyed to determine underlying gender and racial bias. Subjects were consented
to participate in a puzzle competition that involved an element of deception that the PI agrees to reveal at the
conclusion of the experiment.
❖ Public benefit and service programs that are federally funded or conducted by the federal government.
Example: An assessment of emergency room wait times in a Veterans Affairs hospital.
❖ Taste and food quality tests involving ingredients the FDA determines safe for consumption.
Example: A marketing taste test evaluation of a chocolate chip cookie compared to a nutrition bar flavored like a
chocolate chip cookie. Participants will submit surveys to determine whether the healthy nutrition bar is a tasty
substitute for real chocolate chip cookies
CSULB IRB Application for Administrative and Limited Review Version: 01/02/2018
IMPORTANT: NO ACTIVITY MAY BEGIN ON THIS PROJECT UNTIL THE PRINCIPAL INVESTIGATOR HAS
RECEIVED FORMAL NOTIFICATION FROM THE CSULB IRB THAT THE PROJECT HAS BEEN
ACKNOWLEDGED AS A QUALITY ASSESSMENT/QUALITY IMPROVEMENT PROJECT UNDER
ADMINISTRATIVE REVIEW.
1. BASIC INFORMATION
PI’s Name (Last, First, Degree) Chris Smith, PhD
Email chris.smith@csulb.edu
*If you are a student, please complete the information below for your Faculty Advisor:
Email ryan.maganini@csulb.edu
☐ I have attached a signed and completed letter from my faculty advisor as an appendix to
this project in IRBNet.
2. PROJECT SUMMARY
Title of Project
Efficacy of Mobile Application to Deliver Brief Interventions to Mitigate Alcohol Misuse Among Young
Military Veterans
CSULB IRB Application for Administrative and Limited Review Version: 01/02/2018
Describe the purpose of the project. Provide context to the importance of the research and
explain how the results of this study will contribute to the field of study or specific population.
Technological advancements in tablets and smart mobile phones have paved the way for a
new field of interventions (mHealth) to help manage chronic conditions such as alcohol
misuse disorders (AUDs) and general substance use disorders (SUDs). However, to date there
is limited research of mHealth interventions for SUDs among veterans. Research focusing
specifically on alcohol misuse disorders among veterans utilizing these new technologies is
even scarcer. Utilization of mHealth technology has the potential to revolutionize public
health by directly delivering interventions to reach and underserved populations that are
disproportionately affected, like our military veterans. With death counts on par with war
and exorbitant economic impacts as a result of alcohol misuse, it is imperative to investigate
the efficacy of mHealth applications for alcohol misuse and add to the overall body of public
health knowledge.
Inclusion criteria includes: 1) Veteran status; 2) between ages 21-29 years old; 3) Alcohol Use
Disorders Identification Test (AUDIT) score ≥ 8 (as an assessment of high risk drinking). Exclusion
criteria includes: (1) active military or reserve; and (2) lack of access to a smartphone device.
Describe the step-by-step recruitment methods for each subject group (do not include any
other project procedures in this section):
The proposed study will recruit 160 participants from young military veterans from the Tibor Rubin
VA Medical Center in Long Beach, California (see attached letter of support).
List the setting(s) of the research activities (Select all that apply):
CSULB IRB Application for Administrative and Limited Review Version: 01/02/2018
List the location of the research activities (Agency/school names, city, county or social media site):
The proposed study will take place online through a mobile application.
Do you have permission from the facility, institution or director of the organization to conduct
your project? * If yes, please attach signed permission letter or data sharing agreement to this package.
☐ Yes*
☐ No
In Progress
☐ Yes
No
☐ Other (Explain): Click or tap here to enter text.
☐ Yes
No
Describe the step-by-step procedures of your project beginning with the informed consent
process and continuing with all other project activities (all project activities must occur AFTER
IRB approval):
The first step of the project would be an informed consent process, this is when the participant is
informed of all the necessary information pertaining to the study and asks for their permission to
join the program. Study participants, after enrolling in the study, will be asked to log their alcohol
consumption daily, in real-time, through the DrinksRation mobile application. Personalized app
notifications will be prompted based on the number of drinks reported in a given time-period with a
focus on harm reduction using TPB constructs. Study participants will also receive resources through
CSULB IRB Application for Administrative and Limited Review Version: 01/02/2018
the DrinksRation app including educational resources on high risk drinking, resources available for
healthy coping strategies, and short skill-based videos on alcohol-refusal tactics in social settings.
Participants will be prompted with survey questions related to TPB constructs prior to being enrolled
in the study (baseline), at 3 months, and at the conclusion of the study. These surveys will focus on
the participants' perceived attitudes and behaviors during that specific moment in time. The surveys
will allow us to analyze the overall effectiveness of TPB-informed intervention during a six month
period by measuring the impact of the interventions on alcohol consumption among participants
over time. Participants will also receive gift cards incentives to ensure continued participation.
☐ No
Yes (Complete below):
Mode of compensation (Check one):
☐Cash
Gift Card
☐ Course credit
☐ Other (Explain):
Total Amount per Subject: $30 ($10 per each survey).
Justification (Explain): The incentive will be used to encourage participation and engagement in the
study and reduce attrition over the course of the study.
The subjects may experience risks while participating in this project such as feeling discomfort
answering questions, loss of confidentiality, and the potential production of negative affective
states.
Provide a reasonable mitigation to reduce each potential risk listed above. Each
mitigation should directly correspond to each risk (Mitigation for Risk #1, Mitigation for
Risk #2, etc.):
Research procedures will be in place to reduce any potential risks such as any participant data
collected will have identifiers, the data will be stored in an encrypted server and ask only the
necessary questions to prevent discomfort.
4. DATA ACCESS
Who will have access to the data? Program Staff only & Mobile Application
Software owner
*If yes, why is it necessary for identifiable Alcohol misuse is a sensitive topic. If a particular
data to be collected? participant is in need of immediate medical or
mental health intervention it is critical to have
access to identifier information in order to
coordinate with emergency or mental health
services to deliver emergent care.. To deliver
incentives
*If yes, please describe the additional data you will have access to:
*If yes, describe the method(s) to protect subject privacy and confidentiality:
The mobile application developer will provide data security measures and protocols to ensure data
privacy and security of all participants disclosed information. Moreover, a secure database will store
all data collected and, aside from the contracted mobile application developer, the data will only be
shared with the PI and researchers conducting the analysis.
5. FUNDING
Funding Dates: Start: June 05, 2023 End: June 05, 2025
6. RESULTS
Will the results of this project be published?
Yes*
☐ No
CSULB IRB Application for Administrative and Limited Review Version: 01/02/2018
*If yes, for what purpose will the results be published? (Check all that apply)
☐ Personal knowledge
Generalizable knowledge
Program Evaluation
7. ADDITIONAL PERSONNEL
List the name, email and CITI Member ID # for any additional research staff or
assistants that will have access to the research data:
Not Applicable
8. Investigator Assurance
I, the Principal Investigator (PI) for this project certify the following (please check and confirm all):
All subjects in this project will be afforded the same rights and protections.
All provisions to maintain subject confidentiality and protect subject data will be upheld.
The CITI online training is complete for myself and all personnel listed. Training will remain valid
for the duration of research activity.
Research activities will be conducted as described in the approved version of this application.
Any modifications, including personnel changes to this project will be submitted, reviewed
and approved by the CSULB IRB prior to implementation.
I will comply with the CSULB IRB research policies
(http://web.csulb.edu/divisions/aa/research/compliance/humans/#CSULBPolicies)
I will comply with the Department of Health and Human Services (HHS) research policy and regulation
(https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr 46/index.html).
PLEASE ATTACH ALL OTHER RELEVANT DOCUMENTS SUCH AS FACULTY ADVISOR LETTER, PERMISSION LETTERS,
CONSENT FORMS AND RECRUITMENT MATERIAL AS APPENDICES TO THIS PACKAGE SUBMISSION IN IRBNet.
CSULB IRB Application for Administrative and Limited Review Version: 01/02/2018
DEFINITIONS
Research: A systematic investigation (including research development, testing and evaluation) designed to
produce information to expand knowledge of a scientific discipline (Or other scholarly field of study) and
contributes to generalizable knowledge.
Human Subjects: A living individual about whom an investigator conducting research obtains
information or biospecimens through intervention or interaction with the individual and uses studies or
analyzes the information or biospecimens or obtains, uses, studies or generates identifiable private
information or identifiable biospecimens.
QA/QI Projects: Activities that are not designed to produce information that expands the knowledge
base of a scientific discipline (or other scholarly field) and does not constitute as research when it is
designed and implemented for internal knowledge/purposes. Some activities that qualify as QA/QI
include: case management, internal course assignment assessments, patient care coordination, policy
and guideline development, benchmarking activities and department procedural analyses.
Internal Knowledge: Information that solely benefits the intended site or population investigated. The
results are used to assess the quality of procedures, services or activities and used to improve the quality
of those procedures, services or activities.
Identifiable Data/Personal Information: Private health information such as medical record numbers,
social security numbers, address, diagnosis, etc. Alternatively, personal identifiable information such as
name, student ID numbers, demographic information, etc.
For federal regulations regarding QA/QI activities, please visit the Department of Health and Human
Services (DHHS) website: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/quality
improvement-activities/index.html