ClinicalTrials.gg
CompletedNCT03750838Updated Jan 19, 2024Results posted

Alcohol Intervention for First Year College Students

An interventional study of Text Messaging Intervention in Underage Alcohol Use, sponsored by University of North Texas Health Science Center. Completed at 1 site in United States. Open to participants aged 18 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-19.

Sponsored by University of North Texas Health Science Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
18 Years to 19 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Underage Alcohol Use

Browse trials for

03

In context

Underage Drinking

44 studies on the registry are indexed under Underage Drinking; 13 are open to participants now.

This study's enrollment of 99 is below the median of 360 across 43 interventional studies indexed under Underage Drinking.

Browse Underage Drinking studies →

Lead sponsor

University of North Texas Health Science Center is the lead sponsor of 31 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Eligibility criteria includes:

  • age 18-19 (see Identity and Age Verification below; If a participant screens in at 18 and turns 20 prior to the focus group, the participant will be allowed to be in the research study.)
  • birth date that is consistent with their given age
  • first-year college student at the University of North Texas
  • valid email address
  • have a text messaging plan on their mobile phone
  • drinking 14/7 or fewer drinks per week for men/women
  • no episodes in the past month of consuming 5/4 drinks in two hours for men/women
  • express any willingness to take a sip of alcohol
  • if female, must not be pregnant or trying to get pregnant
  • willing to participate in focus groups at the University of North Texas

Exclusion criteria

Exclusion Criteria:

  • Not meeting inclusion criteria
  • unwillingness to participate
  • failure to provide consent (e.g., declining participation in the study)
  • providing inconsistent responses (e.g., age) identified by the survey
  • having already participated in the study as identified by overlap or consistency in computer IP addresses, contact information, and demographics
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
99 participants (actual)

Study arms

  • Experimental
    Text Messaging Intervention Group

    Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful.

    Behavioral: Text Messaging Intervention

  • No intervention
    Assessment Only Control

    Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.

Interventions

  • BehavioralText Messaging Intervention

    The content for the text messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.

06

What researchers measure

Primary outcomes

  1. Acceptability-Number of Participants Who Found the Study Overall Favorable

    Item assessing whether participants found the study overall favorable as measured at 6-week follow-up.

    Time frame: 6 weeks

  2. Acceptability-proportion of Participants Who Would Recommend the Study

    Item assessed by asking whether participants would recommend the study to other first-year college students

    Time frame: 6 weeks

  3. Acceptability and Feasibility-ratings of Text Message Content Areas

    Text Message Rating Scale- assessed ratings of text message intervention content areas with a minimum value of 0 and a maximum value of 4 with higher numbers being a better outcome (i.e., more acceptable)

    Time frame: 6 weeks

Secondary outcomes

  1. 6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking)

    Number of participants who initiated drinking since the baseline assessment

    Time frame: 6 weeks

  2. 3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking)

    Number of participants who initiated drinking at the 3 month assessment since the 6 week assessment

    Time frame: 3 months

  3. 6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)

    Number of participants who initiated alcohol use at 6 month assessment since the 3 month assessment

    Time frame: 6 months

  4. 9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)

    Number of participants who initiated drinking at 9 month assessment since the 6 month assessment

    Time frame: 9 months

  5. 6 Week Alcohol Quantity (Number of Drinks Per Week)

    Number of drinks consumed each week as measured at 6 week assessment

    Time frame: 6 weeks

  6. 3 Month Alcohol Quantity (Number of Drinks)

    Number of drinks consumed each week as measured at 3 month assessment

    Time frame: 3 months

  7. 6 Month Alcohol Quantity (Number of Drinks Consumed Per Week)

    Number of drinks consumed each week as measured at 6 month assessment

    Time frame: 6 months

  8. 9 Month Alcohol Quantity (Number of Drinks Consumed Per Week)

    Number of drinks consumed each week as measured at 9 month assessment

    Time frame: 9 months

07

Results

Posted Jan 19, 2024
Limitations and caveats
The trial, which studied the Freshman college experience, took place during the COVID-19 pandemic, and thus results may not fully generalize.

Participant flow

Campus including in-person recruitment (e.g., tabling, distributing flyers at dorms), online recruitment, and sending student directory email invitations. Flyers advertising recruitment for the study were distributed at the on-campus orientation events and in student dorms with general, brief information about the study, links (URL and QR codes) to the screening survey, and the study's email address, and phone number. We recruited participants from June- August 2021.

Participant flow — Overall Study
MilestoneText Messaging Intervention GroupAssessment Only Control
Started4950
6 week follow-up4043
3 month follow-up3240
6 month follow-up3744
Completed3944
Not completed106
Withdrew: Lost to follow-up106

Outcome measures

PrimaryAcceptability-Number of Participants Who Found the Study Overall Favorable

Item assessing whether participants found the study overall favorable as measured at 6-week follow-up.

Time frame:
6 weeks
Reported as:
Count of participants · Participants
Acceptability-Number of Participants Who Found the Study Overall Favorable
ParticipantsText Messaging Intervention GroupAssessment Only Control
Acceptability-Number of Participants Who Found the Study Overall Favorable380
PrimaryAcceptability-proportion of Participants Who Would Recommend the Study

Item assessed by asking whether participants would recommend the study to other first-year college students

Time frame:
6 weeks
Reported as:
Count of participants · Participants
Acceptability-proportion of Participants Who Would Recommend the Study
ParticipantsText Messaging Intervention GroupAssessment Only Control
Acceptability-proportion of Participants Who Would Recommend the Study360
PrimaryAcceptability and Feasibility-ratings of Text Message Content Areas

Text Message Rating Scale- assessed ratings of text message intervention content areas with a minimum value of 0 and a maximum value of 4 with higher numbers being a better outcome (i.e., more acceptable)

Time frame:
6 weeks
Reported as:
Mean · units on a scale
Acceptability and Feasibility-ratings of Text Message Content Areas
units on a scaleText Messaging Intervention GroupAssessment Only Control
Substance free activities text messages3.27 ± 0.16—
Image text messages3.00 ± 0.47—
Norms text messages2.72 ± 0.66—
Goals text messages2.88 ± 0.33—
Protective Behavioral Strategies text messages2.48 ± 0.14—
Secondary6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking)

Number of participants who initiated drinking since the baseline assessment

Time frame:
6 weeks
Reported as:
Count of participants · Participants
6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking)
ParticipantsText Messaging Intervention GroupAssessment Only Control
6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking)63
Secondary3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking)

Number of participants who initiated drinking at the 3 month assessment since the 6 week assessment

Time frame:
3 months
Reported as:
Count of participants · Participants
3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking)
ParticipantsText Messaging Intervention GroupAssessment Only Control
3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking)43
Secondary6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)

Number of participants who initiated alcohol use at 6 month assessment since the 3 month assessment

Time frame:
6 months
Reported as:
Count of participants · Participants
6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)
ParticipantsText Messaging Intervention GroupAssessment Only Control
6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)47
Secondary9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)

Number of participants who initiated drinking at 9 month assessment since the 6 month assessment

Time frame:
9 months
Reported as:
Count of participants · Participants
9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)
ParticipantsText Messaging Intervention GroupAssessment Only Control
9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)64
Secondary6 Week Alcohol Quantity (Number of Drinks Per Week)

Number of drinks consumed each week as measured at 6 week assessment

Time frame:
6 weeks
Reported as:
Mean · drinks per week
6 Week Alcohol Quantity (Number of Drinks Per Week)
drinks per weekText Messaging Intervention GroupAssessment Only Control
6 Week Alcohol Quantity (Number of Drinks Per Week)1.89 ± 2.982.03 ± 3.34
Secondary3 Month Alcohol Quantity (Number of Drinks)

Number of drinks consumed each week as measured at 3 month assessment

Time frame:
3 months
Reported as:
Mean · drinks per week
3 Month Alcohol Quantity (Number of Drinks)
drinks per weekText Messaging Intervention GroupActive Control
3 Month Alcohol Quantity (Number of Drinks)1.52 ± 2.382.03 ± 2.78
Secondary6 Month Alcohol Quantity (Number of Drinks Consumed Per Week)

Number of drinks consumed each week as measured at 6 month assessment

Time frame:
6 months
Reported as:
Mean · drinks per week
6 Month Alcohol Quantity (Number of Drinks Consumed Per Week)
drinks per weekText Messaging Intervention GroupAssessment Only Control
6 Month Alcohol Quantity (Number of Drinks Consumed Per Week)1.48 ± 2.621.67 ± 3.39
Secondary9 Month Alcohol Quantity (Number of Drinks Consumed Per Week)

Number of drinks consumed each week as measured at 9 month assessment

Time frame:
9 months
Reported as:
Mean · drinks per week
9 Month Alcohol Quantity (Number of Drinks Consumed Per Week)
drinks per weekText Messaging Intervention GroupAssessment Only Control
9 Month Alcohol Quantity (Number of Drinks Consumed Per Week)1.46 ± 2.741.21 ± 2.20

Adverse events

Collected over Data was collected over 9 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Text Messaging Intervention Group0/49 (0%)0/49 (0%)0/49 (0%)
Assessment Only Control0/50 (0%)0/50 (0%)0/50 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Text Messaging Intervention GroupActive ControlTotal
<=18 years000
Between 18 and 65 years495099
>=65 years000
Age, Continuous
Age, Continuous(years)Text Messaging Intervention GroupActive ControlTotal
Mean18.06 ± 0.2418.12 ± 0.3318.09 ± 0.29
Sex: Female, Male
Sex: Female, Male(Participants)Text Messaging Intervention GroupActive ControlTotal
Female363672
Male131427
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Text Messaging Intervention GroupActive ControlTotal
Hispanic or Latino161935
Not Hispanic or Latino333063
Unknown or Not Reported011
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Text Messaging Intervention GroupActive ControlTotal
American Indian or Alaska Native101
Asian527
Native Hawaiian or Other Pacific Islander000
Black or African American10515
White233558
More than one race5510
Unknown or Not Reported538
Region of Enrollment
Region of Enrollment(participants)Text Messaging Intervention GroupActive ControlTotal
United States495099
Current Non-Drinkers
Current Non-Drinkers(Participants)Text Messaging Intervention GroupActive ControlTotal
Count of participants424082
08

Study locations

1 site
  • Dana
    Fort Worth, Texas 76107, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — A select number of researchers will have access to unidentified participant data at the close of the study.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2021 to primary completion in Aug 2023, 26 months.

Results were first posted in Jan 2024, 5 months after primary completion.

Of 34 non-industry interventional studies with no phase under Underage Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 26 months is close to that.

Counting every sponsor, half of 36 studies reached it within 24 months; a quarter within 12 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2018
First posted
Nov 23, 2018
StartActual
Jun 1, 2021
Primary completionActual
Aug 1, 2023
CompletionActual
Aug 1, 2023
Results first posted
Jan 19, 2024
Last update
Jan 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03750838
Lead sponsor
University of North Texas Health Science Center
Responsible party
Dana Litt, PhD. (Associate Professor of Health Behavior and Health Systems, University of North Texas Health Science Center) — Principal investigator
First posted
Nov 23, 2018
Start date
Jun 1, 2021
Primary completion
Aug 1, 2023
Completion
Aug 1, 2023
Results posted
Jan 19, 2024
Last update
Jan 19, 2024

Study contacts

Dana M Litt, PhD.
principal investigator · University of North Texas Health Science Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion