Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03750838 |
| Other study ID # |
R34AA026004 |
| Secondary ID |
1R34AA026004-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
August 1, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
University of North Texas Health Science Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
While a large focus of research on U.S. college drinking has focused on the prevalence of and
problems related to heavy-episodic drinking, less has focused on college students who are
either abstainers or lighter drinkers (i.e., for men, drinking 4 or fewer drinks in two hours
and 14 or fewer drinks per week; and for women drinking 3 or fewer in two hours and 7 or
fewer drinks per week). Over 40% percent of college students ages 18-22 do not report
drinking in the past month with only half of those engaging in regular heavy-episodic
drinking. Research suggests that a significant proportion of students who were abstinent or
light drinkers prior to and upon entering college initiate drinking and progress to becoming
heavy-episodic drinkers. This provides evidence that the first few months of college is a
high-risk time for initiating both drinking and heavy-episodic drinking and that delaying the
onset of heavy-episodic drinking among light drinkers and abstainers should lead to reduced
harms throughout the college years and young adulthood. Mobile phone-based interventions are
an innovative method for reaching young people and have been established as an empirical
approach towards addressing health issues, including alcohol use. The ultimate goal of this
proposal is to develop, refine and pilot a text message (TM) intervention for abstainer and
lighter drinking first year college students with the ultimate goal of delaying alcohol
initiation and/or reducing alcohol use escalation. An iterative process of focus groups,
intervention content development, and user feedback focused on the unique experiences of
abstainers and lighter drinkers will inform the TM Intervention to be delivered in a pilot
study with 6 weeks of TMs. The pilot study will include a 6 week post-intervention
assessment, and 3, 6, and 9 month follow-ups among 100 incoming first year abstainer and
lighter drinker college students. Given that reducing young adults' and college students'
engagement in excessive alcohol use has been listed as a major objective of Healthy People
2020 and a key priority of NIAAA, an intervention that focuses on delaying alcohol initiation
and escalation into higher-risk alcohol use among abstainer and lighter drinkers could make
important strides to achieving this goal.
Description:
The first year at college, and specifically the first 6 weeks of college, has been identified
as a critical period particularly influential to college students' alcohol use trajectories.
The prevalence of heavy drinking increases rapidly upon college entry relative to pre-college
use and patterns of high-risk alcohol use established during the transition to college can
result in a range of adverse consequences that persist throughout the academic year. While a
large focus of research on U.S. college drinking has been on the prevalence of and problems
related to heavy-episodic drinking (4+/5+ drinks in two hours for women/men), less research
has focused on college students who are either abstainers (i.e., do not drink any alcohol) or
lighter drinkers (i.e., men: 4 or fewer drinks in two hours and 14 or fewer drinks per week;
women: 3 or fewer in two hours and 7 or fewer drinks per week). Research indicates that
between 21% and 26% of first-year colleges students who were abstinent or light drinkers
before college escalated to heavy episodic drinking during their freshman year. Further, over
40% percent of college students ages 18-22 do not report drinking in the past month, with
only half of those engaging in regular heavy-episodic drinking. Research indicates that risk
cognitions (i.e., prototypes, norms) are associated with initiation and escalation of alcohol
use and also tend to peak around the time that individuals transition out of high school and
into a riskier college environment. Delaying the onset of heavy-episodic drinking among
abstainers and lighter drinkers during the first-year of college, a particularly high-risk
period, should lead to reduced related harms throughout both the college years and young
adulthood.
Tailoring intervention approaches to students at various levels of risk, including abstainers
or lighter drinkers, may greatly increase efficacy and reduce costs associated with universal
interventions (King et al., 2008). No single intervention is likely to sufficiently reduce
college drinking or consequences; therefore a "mix of strategies is best". An underexplored
strategy is delivering intervention content that reinforces existing reasons for not drinking
among abstainers and lighter drinkers, with the goal of delaying the initiation of heavy
drinking and/or the escalation to heavy drinking during the first year of college. Given that
longitudinal findings indicate that stronger endorsement of reasons for drinking lightly or
not drinking, such as academic responsibilities, normative influence, and concern for social
images are associated with delayed alcohol initiation, lower levels of alcohol use and higher
rates of abstention among young adults, including college students, interventions for
abstainers and lighter drinkers that focus on reinforcing proximal reasons not to drink or to
drink lightly have promise to dissuade students from initiation of drinking or to delay more
hazardous drinking patterns later on.
Additionally, mobile phone-based interventions are an innovative method for reaching young
people and have been established as an evidence-based, recommended approach towards
addressing health issues including alcohol use. Mobile phone text-messaging (TM) offers an
innovative technological approach to brief intervention for college students in a mode in
which they are familiar and they already use frequently. Presenting preventative intervention
content via TM, especially for abstainer and lighter drinking college students, may be one
way to delay alcohol use initiation and prevent the escalation of alcohol use during the
first year of college. Therefore, the present project has the following primary aims:
Aim 1: Recruit first year college students who are abstainers and lighter drinkers to examine
students' reactions to TM intervention content through an iterative process of focus groups,
intervention content development, and user feedback, which will inform a new intervention to
be delivered in a pilot study (Aim 3).
Aim 2: Through focus groups, elicit responses to timing of the TM intervention, specifically
what days and times per week and how many times per day (set within research-established
ranges) abstainer and lighter drinkers think receiving TMs will the most useful and impactful
to inform TM delivery for the pilot study (Aim 3).
Aim 3: Conduct a pilot study with 6 weeks of TM intervention content, a 6 week
post-intervention assessment and 3, 6, and 9 month follow-ups among 100 abstainer or lighter
drinking first-year college students to determine feasibility, acceptability, and preliminary
effect sizes (to estimate power and sample sizes for a future R01). Newly enrolled first-year
college students will be randomized to the TM intervention or assessment only control. The
investigators hypothesize the TM Intervention will be feasible and acceptable to abstainer
and lighter drinking students, including being accessible, usable, convenient, relevant and
helpful. The investigators further hypothesize that receiving the TM intervention will be
associated with less initiation and escalation of drinking, fewer negative consequences, more
favorable prototypes of abstainers and lighter drinkers, greater perceived abstaining and
light drinking norms, greater engagement and enjoyment of alternative activities, and greater
endorsement of personal goals that do not involve alcohol at the 6 week post-intervention
assessment and 3, 6, and 9 month follow-ups relative to assessment only control.
