Trial Outcomes & Findings for Adaptive Preventive Intervention for College Alcohol Use (NCT NCT03930524)
NCT ID: NCT03930524
Last Updated: 2023-04-12
Results Overview
Respondents are asked about the frequency of consuming 4/5+ drinks within a two-hour period in the past 30 days. Questions are based on NIAAA recommended alcohol questions (https://www.niaaa.nih.gov/research/guidelines-and-resources/recommended-alcohol-questions) and Monitoring the Future survey items (http://www.monitoringthefuture.org/).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
891 participants
Primary outcome timeframe
3 months
Results posted on
2023-04-12
Participant Flow
A random sample of 1500 incoming first-year students were mailed a letter at the end of July 2019 inviting them to participate in the M-bridge study. This was followed by an email invitation sent approximately one week later. Participants enrolled via an online consent form through a link that was provided in the invitations. Study recruitment closed mid-August 2019.
Participant milestones
| Measure |
Assessment Only
Assessment Only Control
|
Early-college Universal
Prior to beginning first semester of college, incoming students received personalized normative feedback (PNF) comparing their experiences to other college students their age, as well as up to 4 self-monitoring (SM) surveys over the course of the semester.
Personalized Normative Feedback: PNF is generated by a process in which: 1) baseline surveys gather respondent information; 2) a computer program links the data with algorithms to select feedback messages; 3) a format for feedback presentation is specified; and 4) the program generates output. Norms focus on prevalence of drinking, consuming 4/5+ drinks, total number of drinks consumed each week, and maximum drinks consumed. Normative information is from the national Monitoring the Future (MTF) study college student sample and the University of Minnesota Twin Cities campus. Students were sent a link to a website where they see their own personal responses in the feedback. Feedback details the quantity and frequency of drinking a) reported by the participant themselves, b) according to the participant's perception of the descriptive norm for drinking quantity and frequency for the reference group, and c) reflecting the actual descriptive norm for the reference group.
Self Monitoring: Students were asked to self-report their alcohol use every 2 weeks in response to two main questions (frequency of 4/5+ drinking in the past 2 weeks, frequency of past 2-week 8/10+ drinking),as well as consequences of their drinking.
|
Early-college No Coach (Automated Email)
Students from the early college universal arm, who flagged on one of the self-monitoring surveys were invited to engage in a web-based resource or in-person consultation to improve wellbeing, with a particular emphasis on alcohol use. See PNF and SM described in the early-college Universal arm.
Web-BASICS is delivered online and responds to individual participant input with the same motivational information and feedback as used in the in-person BASICS intervention. In-person BASICS content (Dimeff et. al., 1999) was developed for online use in studies conducted by Drs. Larimer and Lee (e.g., LaBrie et al., 2013; Lee et al., 2014; Neighbors et al., 2012a). Web-BASICS feedback contains text and graphical feedback regarding students' reported drinking quantity, frequency, peak alcohol consumption, and blood alcohol content (BAC), risks for alcohol problems based on participant family history and consumption patterns, protective behaviors the participant already uses and others he/she might consider, and a tips page with a BAC chart, information on reduced-risk drinking, and where to get more information. Participants can print and/or view their individualized content online for up to 3 months.
Health promotion consultation via a campus clinic is a confidential exploration of student drug and alcohol use. Health Promotion Consultants help students assess how their alcohol and other substance use affects their life and learn how to make healthier decisions.
|
Early-college Coach
Students from the early-college universal arm, who flagged on one of the self monitoring surveys were invited to engage with an online health coach. See PNF and SM described in the early-college universal arm.
A M-bridge health coach corresponds with students via a secure online chat platform, utilizing motivational interviewing strategies to encourage students to consider their values and goals, possibility of behavior change, and available services. The goal of the dialogue is to motivate students to access alcohol use interventions (Web-BASICS or an in-person health promotion consultation).
Web-BASICS is delivered online and responds to participant input with the same motivational information and feedback as used in the in-person BASICS intervention. Web-BASICS feedback contains text and graphical feedback regarding students' reported drinking quantity, frequency, peak alcohol consumption, and blood alcohol content (BAC), risks for alcohol problems based on participant family history and consumption patterns, protective behaviors the participant already uses and others they might consider, and a tips page with a BAC chart, information on reduced-risk drinking, and where to get more information.
Health promotion consultation via a campus clinic is a confidential exploration of student drug and alcohol use. Health Promotion Consultants help students assess how their alcohol and other substance use affects their life and learn how to make healthier decisions.
|
Later-college Universal
After beginning their first semester of college, students received personalized normative feedback (PNF) comparing their experiences to other college students their age, as well as up to 4 self-monitoring surveys over the course of the semester.
Personalized Normative Feedback: PNF is generated by a process in which: 1) baseline surveys gather respondent information; 2) a computer program links the data with algorithms to select feedback messages; 3) a format for feedback presentation is specified; and 4) the program generates output. Norms focus on prevalence of drinking, consuming 4/5+ drinks, total number of drinks consumed each week, and maximum drinks consumed. Normative information is from the national Monitoring the Future (MTF) study college student sample and the University of Minnesota Twin Cities campus. Students were sent a link to a website where they see their own personal responses in the feedback. Feedback details the quantity and frequency of drinking a) reported by the participant themselves, b) according to the participant's perception of the descriptive norm for drinking quantity and frequency for the reference group, and c) reflecting the actual descriptive norm for the reference group.
Self Monitoring: Students were asked to self-report their alcohol use every 2 weeks in response to two main questions (frequency of 4/5+ drinking in the past 2 weeks, frequency of past 2-week 8/10+ drinking), as well as consequences of their drinking.
|
Later-college No Coach (Automated Email)
Students from the later-college universal arm, who flag on one of the self-monitoring surveys are invited to engage in a web-based resource or in-person consultation to improve wellbeing, with a particular emphasis on alcohol use. See PNF and SM described in the later-college universal arm.
Web-BASICS is delivered online and responds to individual participant input with the same motivational information and feedback as used in the in-person BASICS intervention. In-person BASICS content (Dimeff et. al., 1999) was developed for online use in studies conducted by Drs. Larimer and Lee (e.g., LaBrie et al., 2013; Lee et al., 2014; Neighbors et al., 2012a). Web-BASICS feedback contains text and graphical feedback regarding students' reported drinking quantity, frequency, peak alcohol consumption, and blood alcohol content (BAC), risks for alcohol problems based on participant family history and consumption patterns, protective behaviors the participant already uses and others he/she might consider, and a tips page with a BAC chart, information on reduced-risk drinking, and where to get more information. Participants can print and/or view their individualized content online for up to 3 months.
Health promotion consultation via a campus clinic is a confidential exploration of student drug and alcohol use. Health Promotion Consultants help students assess how their alcohol and other substance use affects their life and learn how to make healthier decisions.
|
Later-college Coach
Students from the later-college universal arm, who flagged on one of the self-monitoring surveys were to engage with an online health coach. See PNF and SM described in the later-college universal arm.
A M-bridge health coach corresponds with students via a secure online chat platform, utilizing motivational interviewing strategies to encourage students to consider their values and goals, possibility of behavior change, and available services. The goal of the dialogue is to motivate students to access alcohol use interventions (Web-BASICS or an in-person health promotion consultation).
Web-BASICS is delivered online and responds to participant input with the same motivational information and feedback as used in the in-person BASICS intervention. Web-BASICS feedback contains text and graphical feedback regarding students' reported drinking quantity, frequency, peak alcohol consumption, and blood alcohol content (BAC), risks for alcohol problems based on participant family history and consumption patterns, protective behaviors the participant already uses and others they might consider, and a tips page with a BAC chart, information on reduced-risk drinking, and where to get more information.
Health promotion consultation via a campus clinic is a confidential exploration of student drug and alcohol use. Health Promotion Consultants help students assess how their alcohol and other substance use affects their life and learn how to make healthier decisions.
|
|---|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
300
|
295
|
0
|
0
|
296
|
0
|
0
|
|
Stage 1
COMPLETED
|
274
|
254
|
0
|
0
|
253
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
26
|
41
|
0
|
0
|
43
|
0
|
0
|
|
Stage 2 ("Heavy Drinkers")
STARTED
|
0
|
0
|
38
|
37
|
0
|
40
|
43
|
|
Stage 2 ("Heavy Drinkers")
COMPLETED
|
0
|
0
|
36
|
34
|
0
|
33
|
40
|
|
Stage 2 ("Heavy Drinkers")
NOT COMPLETED
|
0
|
0
|
2
|
3
|
0
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adaptive Preventive Intervention for College Alcohol Use
Baseline characteristics by cohort
| Measure |
Assessment Only
n=300 Participants
Assessment Only Control
|
Early-college Universal
n=295 Participants
Prior to beginning first semester of college, incoming students received personalized normative feedback (PNF) comparing their experiences to other college students their age, as well as up to 4 self-monitoring (SM) surveys over the course of the semester.
|
Later-college Universal
n=296 Participants
After beginning their first semester of college, students received personalized normative feedback (PNF) comparing their experiences to other college students their age, as well as up to 4 self-monitoring surveys over the course of the semester.
|
Total
n=891 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
18.1 years
STANDARD_DEVIATION 0.218 • n=5 Participants
|
18.1 years
STANDARD_DEVIATION 0.281 • n=7 Participants
|
18.1 years
STANDARD_DEVIATION 0.227 • n=5 Participants
|
18.1 years
STANDARD_DEVIATION 0.243 • n=4 Participants
|
|
Sex: Female, Male
Female
|
184 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
556 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
335 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian Non-Hispanic
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black Non-Hispanic
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/Latinx
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White Non-Hispanic
|
233 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
684 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
300 Participants
n=5 Participants
|
295 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
891 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: The data reported is for API vs. Assessment Only because the primary aim of the grant was to examine intervention vs. control group differences. As such, this is how the data was analyzed and reported.
Respondents are asked about the frequency of consuming 4/5+ drinks within a two-hour period in the past 30 days. Questions are based on NIAAA recommended alcohol questions (https://www.niaaa.nih.gov/research/guidelines-and-resources/recommended-alcohol-questions) and Monitoring the Future survey items (http://www.monitoringthefuture.org/).
Outcome measures
| Measure |
Adaptive Preventive Intervention (API)
n=591 Participants
Participants who were randomized to any one of the four APIs embedded in the SMART.
|
Assessment Only
n=300 Participants
Participants who were randomized to the assessment only control arm.
|
|---|---|---|
|
Binge Drinking
|
1.034 Number of times
Standard Deviation 1.706
|
1.129 Number of times
Standard Deviation 1.843
|
Adverse Events
Assessment Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Early-college Universal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Later-college Universal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place