Trial Outcomes & Findings for Alcohol & Mobile Phone Study to Reduce High-risk Alcohol Use and Consequences (NCT NCT04213846)
NCT ID: NCT04213846
Last Updated: 2024-09-26
Results Overview
The count of self-reported typical number of drinks consumed per week during the past month
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
408 participants
Primary outcome timeframe
Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up
Results posted on
2024-09-26
Participant Flow
Participant milestones
| Measure |
Assessment-only Control
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Mobile Alcohol Expectancy Intervention
Experimental: Mobile Alcohol Expectancy Intervention: Participants randomized to the intervention condition will receive daily intervention messages two times a day for three weeks in the mobile app. The intervention uses participants' own daily responses to personalize messages, when appropriate, that challenges their personal expectations of alcohol's positive effects on mood, social facilitation, and tension reduction, as well as aggression and risk-taking. The intervention messages also focus on intentions to drink and pharmacologically-delayed negative effects. Intervention Messages in general will include feedback based on selected assessment items, weekly summaries generated from the daily assessments, general psycho-educational messages and videos about alcohol, and a toolbox with supplemental information (e.g., personal BAC calculators, resources).
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
205
|
|
Overall Study
COMPLETED
|
181
|
178
|
|
Overall Study
NOT COMPLETED
|
22
|
27
|
Reasons for withdrawal
| Measure |
Assessment-only Control
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Mobile Alcohol Expectancy Intervention
Experimental: Mobile Alcohol Expectancy Intervention: Participants randomized to the intervention condition will receive daily intervention messages two times a day for three weeks in the mobile app. The intervention uses participants' own daily responses to personalize messages, when appropriate, that challenges their personal expectations of alcohol's positive effects on mood, social facilitation, and tension reduction, as well as aggression and risk-taking. The intervention messages also focus on intentions to drink and pharmacologically-delayed negative effects. Intervention Messages in general will include feedback based on selected assessment items, weekly summaries generated from the daily assessments, general psycho-educational messages and videos about alcohol, and a toolbox with supplemental information (e.g., personal BAC calculators, resources).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
|
Overall Study
Lost to Follow-up
|
15
|
21
|
Baseline Characteristics
Alcohol & Mobile Phone Study to Reduce High-risk Alcohol Use and Consequences
Baseline characteristics by cohort
| Measure |
Assessment-only Control
n=203 Participants
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Mobile Alcohol Expectancy Intervention
n=205 Participants
Experimental: Mobile Alcohol Expectancy Intervention: Participants randomized to the intervention condition will receive daily intervention messages two times a day for three weeks in the mobile app. The intervention uses participants' own daily responses to personalize messages, when appropriate, that challenges their personal expectations of alcohol's positive effects on mood, social facilitation, and tension reduction, as well as aggression and risk-taking. The intervention messages also focus on intentions to drink and pharmacologically-delayed negative effects. Intervention Messages in general will include feedback based on selected assessment items, weekly summaries generated from the daily assessments, general psycho-educational messages and videos about alcohol, and a toolbox with supplemental information (e.g., personal BAC calculators, resources).
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
203 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
408 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
20.78 years
STANDARD_DEVIATION 1.59 • n=5 Participants
|
20.90 years
STANDARD_DEVIATION 1.66 • n=7 Participants
|
20.84 years
STANDARD_DEVIATION 1.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
167 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
336 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
125 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
203 participants
n=5 Participants
|
205 participants
n=7 Participants
|
408 participants
n=5 Participants
|
|
School Type
4-year college
|
153 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
School Type
2-year college
|
50 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-upPopulation: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
The count of self-reported typical number of drinks consumed per week during the past month
Outcome measures
| Measure |
Assessment-only Control
n=203 Participants
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Mobile Alcohol Expectancy Intervention
n=205 Participants
Experimental: Mobile Alcohol Expectancy Intervention: Participants randomized to the intervention condition will receive daily intervention messages two times a day for three weeks in the mobile app. The intervention uses participants' own daily responses to personalize messages, when appropriate, that challenges their personal expectations of alcohol's positive effects on mood, social facilitation, and tension reduction, as well as aggression and risk-taking. The intervention messages also focus on intentions to drink and pharmacologically-delayed negative effects. Intervention Messages in general will include feedback based on selected assessment items, weekly summaries generated from the daily assessments, general psycho-educational messages and videos about alcohol, and a toolbox with supplemental information (e.g., personal BAC calculators, resources).
|
|---|---|---|
|
Daily Drinking Questionnaire - Typical Number of Drinks Per Week
Baseline
|
13.51 drinks
Standard Deviation 10.17
|
12.23 drinks
Standard Deviation 8.49
|
|
Daily Drinking Questionnaire - Typical Number of Drinks Per Week
1-month follow-up
|
10.70 drinks
Standard Deviation 10.29
|
8.95 drinks
Standard Deviation 7.76
|
|
Daily Drinking Questionnaire - Typical Number of Drinks Per Week
6-month follow-up
|
9.46 drinks
Standard Deviation 9.47
|
9.06 drinks
Standard Deviation 8.46
|
|
Daily Drinking Questionnaire - Typical Number of Drinks Per Week
12-month follow-up
|
9.91 drinks
Standard Deviation 11.22
|
8.81 drinks
Standard Deviation 7.83
|
PRIMARY outcome
Timeframe: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-upPopulation: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
The eBAC reached during the heaviest drinking episode during the past month based on self-reported number of drinks, sex, and hours drinking
Outcome measures
| Measure |
Assessment-only Control
n=203 Participants
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Mobile Alcohol Expectancy Intervention
n=205 Participants
Experimental: Mobile Alcohol Expectancy Intervention: Participants randomized to the intervention condition will receive daily intervention messages two times a day for three weeks in the mobile app. The intervention uses participants' own daily responses to personalize messages, when appropriate, that challenges their personal expectations of alcohol's positive effects on mood, social facilitation, and tension reduction, as well as aggression and risk-taking. The intervention messages also focus on intentions to drink and pharmacologically-delayed negative effects. Intervention Messages in general will include feedback based on selected assessment items, weekly summaries generated from the daily assessments, general psycho-educational messages and videos about alcohol, and a toolbox with supplemental information (e.g., personal BAC calculators, resources).
|
|---|---|---|
|
Peak Estimated Blood Alcohol Concentration (Peak eBAC)
Baseline
|
0.19 grams per deciliter
Standard Deviation 0.14
|
0.16 grams per deciliter
Standard Deviation 0.10
|
|
Peak Estimated Blood Alcohol Concentration (Peak eBAC)
1-month follow-up
|
0.15 grams per deciliter
Standard Deviation 0.11
|
0.14 grams per deciliter
Standard Deviation 0.11
|
|
Peak Estimated Blood Alcohol Concentration (Peak eBAC)
6-month follow-up
|
0.14 grams per deciliter
Standard Deviation 0.12
|
0.13 grams per deciliter
Standard Deviation 0.10
|
|
Peak Estimated Blood Alcohol Concentration (Peak eBAC)
12-month follow-up
|
0.14 grams per deciliter
Standard Deviation 0.11
|
0.13 grams per deciliter
Standard Deviation 0.10
|
PRIMARY outcome
Timeframe: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-upPopulation: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
Self-reported number of days of heavy episodic drinking (4+ drinks for females/5+ drinks for males) in the past two weeks
Outcome measures
| Measure |
Assessment-only Control
n=203 Participants
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Mobile Alcohol Expectancy Intervention
n=205 Participants
Experimental: Mobile Alcohol Expectancy Intervention: Participants randomized to the intervention condition will receive daily intervention messages two times a day for three weeks in the mobile app. The intervention uses participants' own daily responses to personalize messages, when appropriate, that challenges their personal expectations of alcohol's positive effects on mood, social facilitation, and tension reduction, as well as aggression and risk-taking. The intervention messages also focus on intentions to drink and pharmacologically-delayed negative effects. Intervention Messages in general will include feedback based on selected assessment items, weekly summaries generated from the daily assessments, general psycho-educational messages and videos about alcohol, and a toolbox with supplemental information (e.g., personal BAC calculators, resources).
|
|---|---|---|
|
Number of Heavy Episodic Drinking Days
6-month follow-up
|
2.07 Number of days
Standard Deviation 2.20
|
2.04 Number of days
Standard Deviation 2.37
|
|
Number of Heavy Episodic Drinking Days
12-month follow-up
|
2.03 Number of days
Standard Deviation 2.13
|
1.83 Number of days
Standard Deviation 2.02
|
|
Number of Heavy Episodic Drinking Days
Baseline
|
2.85 Number of days
Standard Deviation 2.22
|
2.85 Number of days
Standard Deviation 2.13
|
|
Number of Heavy Episodic Drinking Days
1-month follow-up
|
2.26 Number of days
Standard Deviation 2.32
|
1.87 Number of days
Standard Deviation 1.95
|
PRIMARY outcome
Timeframe: Baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-upPopulation: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
Total sum score on the Brief Young Adult Alcohol Consequences Questionnaire based on number of self-reported alcohol-related consequences experienced in the past month (range from 0-24 consequences). Higher scores indicate reporting greater number of negative alcohol-related consequences.
Outcome measures
| Measure |
Assessment-only Control
n=203 Participants
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Mobile Alcohol Expectancy Intervention
n=205 Participants
Experimental: Mobile Alcohol Expectancy Intervention: Participants randomized to the intervention condition will receive daily intervention messages two times a day for three weeks in the mobile app. The intervention uses participants' own daily responses to personalize messages, when appropriate, that challenges their personal expectations of alcohol's positive effects on mood, social facilitation, and tension reduction, as well as aggression and risk-taking. The intervention messages also focus on intentions to drink and pharmacologically-delayed negative effects. Intervention Messages in general will include feedback based on selected assessment items, weekly summaries generated from the daily assessments, general psycho-educational messages and videos about alcohol, and a toolbox with supplemental information (e.g., personal BAC calculators, resources).
|
|---|---|---|
|
Brief Young Adult Alcohol Consequences Questionnaire
Baseline
|
9.14 number of consequences
Standard Deviation 3.82
|
8.88 number of consequences
Standard Deviation 4.12
|
|
Brief Young Adult Alcohol Consequences Questionnaire
1-month follow-up
|
5.92 number of consequences
Standard Deviation 4.41
|
5.85 number of consequences
Standard Deviation 5.17
|
|
Brief Young Adult Alcohol Consequences Questionnaire
6-month follow-up
|
5.95 number of consequences
Standard Deviation 4.93
|
5.16 number of consequences
Standard Deviation 4.70
|
|
Brief Young Adult Alcohol Consequences Questionnaire
12-month follow-up
|
5.97 number of consequences
Standard Deviation 4.58
|
5.89 number of consequences
Standard Deviation 4.78
|
SECONDARY outcome
Timeframe: Baseline and 12-month follow-upPopulation: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
Measure of hazardous/harmful drinking in the past year based on indicators of alcohol use disorder (Total score range: 0-40, with higher values indicating greater hazardous/harmful drinking)
Outcome measures
| Measure |
Assessment-only Control
n=203 Participants
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
|
Mobile Alcohol Expectancy Intervention
n=205 Participants
Experimental: Mobile Alcohol Expectancy Intervention: Participants randomized to the intervention condition will receive daily intervention messages two times a day for three weeks in the mobile app. The intervention uses participants' own daily responses to personalize messages, when appropriate, that challenges their personal expectations of alcohol's positive effects on mood, social facilitation, and tension reduction, as well as aggression and risk-taking. The intervention messages also focus on intentions to drink and pharmacologically-delayed negative effects. Intervention Messages in general will include feedback based on selected assessment items, weekly summaries generated from the daily assessments, general psycho-educational messages and videos about alcohol, and a toolbox with supplemental information (e.g., personal BAC calculators, resources).
|
|---|---|---|
|
Alcohol Use Disorder Identification Test Total Score
Baseline
|
12.52 units on a scale
Standard Deviation 5.46
|
11.88 units on a scale
Standard Deviation 4.87
|
|
Alcohol Use Disorder Identification Test Total Score
12-month follow-up
|
10.72 units on a scale
Standard Deviation 5.68
|
10.04 units on a scale
Standard Deviation 5.34
|
Adverse Events
Assessment-only Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mobile Alcohol Expectancy Intervention
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