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
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.
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.
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 →University of North Texas Health Science Center is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
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Eligibility criteria includes:
Exclusion Criteria:
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
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.
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.
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
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
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
6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking)
Number of participants who initiated drinking since the baseline assessment
Time frame: 6 weeks
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
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
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
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
3 Month Alcohol Quantity (Number of Drinks)
Number of drinks consumed each week as measured at 3 month assessment
Time frame: 3 months
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
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
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.
| Milestone | Text Messaging Intervention Group | Assessment Only Control |
|---|---|---|
| Started | 49 | 50 |
| 6 week follow-up | 40 | 43 |
| 3 month follow-up | 32 | 40 |
| 6 month follow-up | 37 | 44 |
| Completed | 39 | 44 |
| Not completed | 10 | 6 |
| Withdrew: Lost to follow-up | 10 | 6 |
Item assessing whether participants found the study overall favorable as measured at 6-week follow-up.
| Participants | Text Messaging Intervention Group | Assessment Only Control |
|---|---|---|
| Acceptability-Number of Participants Who Found the Study Overall Favorable | 38 | 0 |
Item assessed by asking whether participants would recommend the study to other first-year college students
| Participants | Text Messaging Intervention Group | Assessment Only Control |
|---|---|---|
| Acceptability-proportion of Participants Who Would Recommend the Study | 36 | 0 |
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)
| units on a scale | Text Messaging Intervention Group | Assessment Only Control |
|---|---|---|
| Substance free activities text messages | 3.27 ± 0.16 | — |
| Image text messages | 3.00 ± 0.47 | — |
| Norms text messages | 2.72 ± 0.66 | — |
| Goals text messages | 2.88 ± 0.33 | — |
| Protective Behavioral Strategies text messages | 2.48 ± 0.14 | — |
Number of participants who initiated drinking since the baseline assessment
| Participants | Text Messaging Intervention Group | Assessment Only Control |
|---|---|---|
| 6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking) | 6 | 3 |
Number of participants who initiated drinking at the 3 month assessment since the 6 week assessment
| Participants | Text Messaging Intervention Group | Assessment Only Control |
|---|---|---|
| 3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking) | 4 | 3 |
Number of participants who initiated alcohol use at 6 month assessment since the 3 month assessment
| Participants | Text Messaging Intervention Group | Assessment Only Control |
|---|---|---|
| 6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use) | 4 | 7 |
Number of participants who initiated drinking at 9 month assessment since the 6 month assessment
| Participants | Text Messaging Intervention Group | Assessment Only Control |
|---|---|---|
| 9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use) | 6 | 4 |
Number of drinks consumed each week as measured at 6 week assessment
| drinks per week | Text Messaging Intervention Group | Assessment Only Control |
|---|---|---|
| 6 Week Alcohol Quantity (Number of Drinks Per Week) | 1.89 ± 2.98 | 2.03 ± 3.34 |
Number of drinks consumed each week as measured at 3 month assessment
| drinks per week | Text Messaging Intervention Group | Active Control |
|---|---|---|
| 3 Month Alcohol Quantity (Number of Drinks) | 1.52 ± 2.38 | 2.03 ± 2.78 |
Number of drinks consumed each week as measured at 6 month assessment
| drinks per week | Text Messaging Intervention Group | Assessment Only Control |
|---|---|---|
| 6 Month Alcohol Quantity (Number of Drinks Consumed Per Week) | 1.48 ± 2.62 | 1.67 ± 3.39 |
Number of drinks consumed each week as measured at 9 month assessment
| drinks per week | Text Messaging Intervention Group | Assessment Only Control |
|---|---|---|
| 9 Month Alcohol Quantity (Number of Drinks Consumed Per Week) | 1.46 ± 2.74 | 1.21 ± 2.20 |
Collected over Data was collected over 9 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Text Messaging Intervention Group | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Assessment Only Control | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Categorical(Participants) | Text Messaging Intervention Group | Active Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 49 | 50 | 99 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Text Messaging Intervention Group | Active Control | Total |
|---|---|---|---|
| Mean | 18.06 ± 0.24 | 18.12 ± 0.33 | 18.09 ± 0.29 |
| Sex: Female, Male(Participants) | Text Messaging Intervention Group | Active Control | Total |
|---|---|---|---|
| Female | 36 | 36 | 72 |
| Male | 13 | 14 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Text Messaging Intervention Group | Active Control | Total |
|---|---|---|---|
| Hispanic or Latino | 16 | 19 | 35 |
| Not Hispanic or Latino | 33 | 30 | 63 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Text Messaging Intervention Group | Active Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 5 | 2 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 5 | 15 |
| White | 23 | 35 | 58 |
| More than one race | 5 | 5 | 10 |
| Unknown or Not Reported | 5 | 3 | 8 |
| Region of Enrollment(participants) | Text Messaging Intervention Group | Active Control | Total |
|---|---|---|---|
| United States | 49 | 50 | 99 |
| Current Non-Drinkers(Participants) | Text Messaging Intervention Group | Active Control | Total |
|---|---|---|---|
| Count of participants | 42 | 40 | 82 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — A select number of researchers will have access to unidentified participant data at the close of the study.
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.
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of North Texas Health Science Center