Skip to content

Alcohol Intervention for First Year College Students

Refining and Piloting a Text Messaging Intervention to Delay Alcohol Initiation and Reduce Alcohol Use Escalation Among Abstainer and Lighter Drinker College Students

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03750838
Enrollment
99
Registered
2018-11-23
Start date
2021-06-01
Completion date
2023-08-01
Last updated
2024-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Underage Alcohol Use

Brief 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.

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.

Interventions

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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of North Texas Health Science Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 19 Years
Healthy volunteers
Yes

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability-Number of Participants Who Found the Study Overall Favorable6 weeksItem assessing whether participants found the study overall favorable as measured at 6-week follow-up.
Acceptability-proportion of Participants Who Would Recommend the Study6 weeksItem assessed by asking whether participants would recommend the study to other first-year college students
Acceptability and Feasibility-ratings of Text Message Content Areas6 weeksText 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)

Secondary

MeasureTime frameDescription
9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)9 monthsNumber of participants who initiated drinking at 9 month assessment since the 6 month assessment
6 Week Alcohol Quantity (Number of Drinks Per Week)6 weeksNumber of drinks consumed each week as measured at 6 week assessment
6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking)6 weeksNumber of participants who initiated drinking since the baseline assessment
6 Month Alcohol Quantity (Number of Drinks Consumed Per Week)6 monthsNumber of drinks consumed each week as measured at 6 month assessment
9 Month Alcohol Quantity (Number of Drinks Consumed Per Week)9 monthsNumber of drinks consumed each week as measured at 9 month assessment
3 Month Alcohol Quantity (Number of Drinks)3 monthsNumber of drinks consumed each week as measured at 3 month assessment
3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking)3 monthsNumber of participants who initiated drinking at the 3 month assessment since the 6 week assessment
6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)6 monthsNumber of participants who initiated alcohol use at 6 month assessment since the 3 month assessment

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

Participants who were eligible, but did not complete the baseline survey were not fully enrolled and randomized to condition.

Participants by arm

ArmCount
Text Messaging Intervention Group
Participants in the TM 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. Text Messaging Intervention: The content for the TM 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.
49
Active Control
Participants in the attention only control condition will receive a series of TM based on nutritional data on the same schedule as those in the TM intervention and will complete a 6 week post-intervention assessment as well as all follow-ups. Active Control: Participants will receive a series of TM based on nutritional data on the same schedule as those in the TM intervention and will complete a 6 week post-intervention assessment as well as all follow-ups.
50
Total99

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up106

Baseline characteristics

CharacteristicText Messaging Intervention GroupActive ControlTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
49 Participants50 Participants99 Participants
Age, Continuous18.06 years
STANDARD_DEVIATION 0.24
18.12 years
STANDARD_DEVIATION 0.33
18.09 years
STANDARD_DEVIATION 0.29
Current Non-Drinkers42 Participants40 Participants82 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants19 Participants35 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants30 Participants63 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
5 Participants2 Participants7 Participants
Race (NIH/OMB)
Black or African American
10 Participants5 Participants15 Participants
Race (NIH/OMB)
More than one race
5 Participants5 Participants10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants3 Participants8 Participants
Race (NIH/OMB)
White
23 Participants35 Participants58 Participants
Region of Enrollment
United States
49 participants50 participants99 participants
Sex: Female, Male
Female
36 Participants36 Participants72 Participants
Sex: Female, Male
Male
13 Participants14 Participants27 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 490 / 50
other
Total, other adverse events
0 / 490 / 50
serious
Total, serious adverse events
0 / 490 / 50

Outcome results

Primary

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

Population: Acceptability was only measured for those in text message intervention group

ArmMeasureGroupValue (MEAN)Dispersion
Text Messaging Intervention GroupAcceptability and Feasibility-ratings of Text Message Content AreasSubstance free activities text messages3.27 units on a scaleStandard Deviation 0.16
Text Messaging Intervention GroupAcceptability and Feasibility-ratings of Text Message Content AreasImage text messages3.00 units on a scaleStandard Deviation 0.47
Text Messaging Intervention GroupAcceptability and Feasibility-ratings of Text Message Content AreasNorms text messages2.72 units on a scaleStandard Deviation 0.66
Text Messaging Intervention GroupAcceptability and Feasibility-ratings of Text Message Content AreasGoals text messages2.88 units on a scaleStandard Deviation 0.33
Text Messaging Intervention GroupAcceptability and Feasibility-ratings of Text Message Content AreasProtective Behavioral Strategies text messages2.48 units on a scaleStandard Deviation 0.14
Primary

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

Population: Acceptability data only collected from intervention group

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Text Messaging Intervention GroupAcceptability-Number of Participants Who Found the Study Overall Favorable38 Participants
Assessment Only ControlAcceptability-Number of Participants Who Found the Study Overall Favorable0 Participants
Primary

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

Population: Only those participants assigned to intervention were shown these items.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Text Messaging Intervention GroupAcceptability-proportion of Participants Who Would Recommend the Study36 Participants
Assessment Only ControlAcceptability-proportion of Participants Who Would Recommend the Study0 Participants
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Text Messaging Intervention Group3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking)4 Participants
Assessment Only Control3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking)3 Participants
Secondary

3 Month Alcohol Quantity (Number of Drinks)

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

Time frame: 3 months

Population: Mean and SD of number of drinks consumed each week using the Daily Drinking Questionnaire

ArmMeasureValue (MEAN)Dispersion
Text Messaging Intervention Group3 Month Alcohol Quantity (Number of Drinks)1.52 drinks per weekStandard Deviation 2.38
Assessment Only Control3 Month Alcohol Quantity (Number of Drinks)2.03 drinks per weekStandard Deviation 2.78
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Text Messaging Intervention Group6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)4 Participants
Assessment Only Control6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)7 Participants
Secondary

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

Population: Mean and SD of number of drinks consumed each week using the Daily Drinking Questionnaire

ArmMeasureValue (MEAN)Dispersion
Text Messaging Intervention Group6 Month Alcohol Quantity (Number of Drinks Consumed Per Week)1.48 drinks per weekStandard Deviation 2.62
Assessment Only Control6 Month Alcohol Quantity (Number of Drinks Consumed Per Week)1.67 drinks per weekStandard Deviation 3.39
Secondary

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

Number of participants who initiated drinking since the baseline assessment

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Text Messaging Intervention Group6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking)6 Participants
Assessment Only Control6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking)3 Participants
Secondary

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

Population: Mean and SD of number of drinks consumed each week using the Daily Drinking Questionnaire

ArmMeasureValue (MEAN)Dispersion
Text Messaging Intervention Group6 Week Alcohol Quantity (Number of Drinks Per Week)1.89 drinks per weekStandard Deviation 2.98
Assessment Only Control6 Week Alcohol Quantity (Number of Drinks Per Week)2.03 drinks per weekStandard Deviation 3.34
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Text Messaging Intervention Group9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)6 Participants
Assessment Only Control9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)4 Participants
Secondary

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

Population: Mean and SD of number of drinks consumed each week using the Daily Drinking Questionnaire

ArmMeasureValue (MEAN)Dispersion
Text Messaging Intervention Group9 Month Alcohol Quantity (Number of Drinks Consumed Per Week)1.46 drinks per weekStandard Deviation 2.74
Assessment Only Control9 Month Alcohol Quantity (Number of Drinks Consumed Per Week)1.21 drinks per weekStandard Deviation 2.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026