Trial Outcomes & Findings for Efficacy of a Web-Based Alcohol Intervention for High School Students (NCT NCT03613818)
NCT ID: NCT03613818
Last Updated: 2021-04-01
Results Overview
Daily Drinking Questionnaire Weekly drinking was assessed with the question "Given that it is a typical week, please write the number of drinks you probably would have each day." A response scale is provided for each day of the week (e.g., Monday\_\_, Tuesday\_\_, etc.)." Weekly drinking was calculated by combining the reports for the seven days of the week (sum of the 7 days). Minimum = 0; Maximum = none Sample score range: Minimum = 0; Maximum = 26 Higher scores are worse outcomes
COMPLETED
NA
311 participants
Baseline, 1 month follow-up, and 6-month follow up
2021-04-01
Participant Flow
Participant milestones
| Measure |
eCHECKUP TO GO
Brief, web-based alcohol intervention
eCHECKUP TO GO: eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking
|
Control
Assessment only
|
|---|---|---|
|
Overall Study
STARTED
|
174
|
137
|
|
Overall Study
COMPLETED
|
137
|
110
|
|
Overall Study
NOT COMPLETED
|
37
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of a Web-Based Alcohol Intervention for High School Students
Baseline characteristics by cohort
| Measure |
eCHECKUP TO GO
n=174 Participants
Brief, web-based alcohol intervention
eCHECKUP TO GO: eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking
|
Control
n=137 Participants
Assessment only
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.13 years
STANDARD_DEVIATION 0.46 • n=5 Participants
|
17.13 years
STANDARD_DEVIATION 0.45 • n=7 Participants
|
17.13 years
STANDARD_DEVIATION 0.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
152 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
174 participants
n=5 Participants
|
137 participants
n=7 Participants
|
311 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 month follow-up, and 6-month follow upPopulation: One participant was removed from the analyses due to unreliable reporting
Daily Drinking Questionnaire Weekly drinking was assessed with the question "Given that it is a typical week, please write the number of drinks you probably would have each day." A response scale is provided for each day of the week (e.g., Monday\_\_, Tuesday\_\_, etc.)." Weekly drinking was calculated by combining the reports for the seven days of the week (sum of the 7 days). Minimum = 0; Maximum = none Sample score range: Minimum = 0; Maximum = 26 Higher scores are worse outcomes
Outcome measures
| Measure |
eCHECKUP TO GO
n=173 Participants
Brief, web-based alcohol intervention
eCHECKUP TO GO: eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking
|
Control
n=137 Participants
Assessment only
|
|---|---|---|
|
Weekly Drinking
Basline
|
4.14 drinks per week
Standard Deviation 6.74
|
3.06 drinks per week
Standard Deviation 6.39
|
|
Weekly Drinking
1 Month Follow-Up
|
2.92 drinks per week
Standard Deviation 4.93
|
2.55 drinks per week
Standard Deviation 5.32
|
|
Weekly Drinking
6 Month Follow-Up
|
2.23 drinks per week
Standard Deviation 3.94
|
2.14 drinks per week
Standard Deviation 5.04
|
PRIMARY outcome
Timeframe: Baseline, 1 month follow-up, and 6-month follow upPopulation: One participant was removed from the analyses due to unreliable reporting
Quantity ⁄Frequency ⁄Peak Questionnaire Peak drinking quantity was assessed with the question "What is the most number of drinks that you have consumed on any given night in the past month?" Minimum = 0; Maximum = none Sample score range: Minimum = 0; Maximum = 25 Higher scores are worse outcomes
Outcome measures
| Measure |
eCHECKUP TO GO
n=173 Participants
Brief, web-based alcohol intervention
eCHECKUP TO GO: eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking
|
Control
n=137 Participants
Assessment only
|
|---|---|---|
|
Peak Drinking Quantity
Baseline
|
5.10 drinks
Standard Deviation 6.01
|
2.81 drinks
Standard Deviation 5.13
|
|
Peak Drinking Quantity
1 Month Follow-Up
|
3.65 drinks
Standard Deviation 4.48
|
2.53 drinks
Standard Deviation 4.89
|
|
Peak Drinking Quantity
6 Month Follow-Up
|
3.63 drinks
Standard Deviation 4.86
|
2.40 drinks
Standard Deviation 4.58
|
PRIMARY outcome
Timeframe: Baseline, 1 month follow-up, and 6-month follow upPopulation: One participant was removed from the analyses due to unreliable reporting
Quantity ⁄Frequency ⁄Peak Questionnaire Frequency of alcohol use was assessed with the question "How often do you use alcohol?" with responses provided on an 8-point Likert scale with options ranging from "0" to "7" ("Do not drink alcohol" to "Every day"). Items were reverse scores so higher scores represent higher levels of drinking frequency. Minimum = 0; Maximum = 7 Sample score range: Minimum = 0; Maximum = 7 Higher scores are worse outcomes
Outcome measures
| Measure |
eCHECKUP TO GO
n=173 Participants
Brief, web-based alcohol intervention
eCHECKUP TO GO: eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking
|
Control
n=137 Participants
Assessment only
|
|---|---|---|
|
Frequency of Alcohol Use
Baseline
|
3.71 score on a scale
Standard Deviation 1.94
|
2.84 score on a scale
Standard Deviation 1.91
|
|
Frequency of Alcohol Use
1 Month Follow-Up
|
3.61 score on a scale
Standard Deviation 1.89
|
2.72 score on a scale
Standard Deviation 1.81
|
|
Frequency of Alcohol Use
6 Month Follow-Up
|
3.41 score on a scale
Standard Deviation 1.80
|
2.62 score on a scale
Standard Deviation 1.77
|
PRIMARY outcome
Timeframe: Baseline, 1 month follow-up, and 6-month follow upPopulation: One participant was removed from the analyses due to unreliable reporting
Blood alcohol concentration was calculated using the Widmark Formula (1932/1981); BAC = \[Alcohol consumed in grams / (Body weight in grams x r)\] x 100. In this formula, "r" is the gender constant. Minimum = 0; Maximum = none Sample score range: Minimum = 0; Maximum = .62 Higher scores are worse outcomes
Outcome measures
| Measure |
eCHECKUP TO GO
n=173 Participants
Brief, web-based alcohol intervention
eCHECKUP TO GO: eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking
|
Control
n=137 Participants
Assessment only
|
|---|---|---|
|
Blood Alcohol Concentration
Baseline
|
.11 percentage of alcohol/100 ml of blood
Standard Deviation .16
|
.06 percentage of alcohol/100 ml of blood
Standard Deviation .11
|
|
Blood Alcohol Concentration
1 Month Follow-Up
|
.07 percentage of alcohol/100 ml of blood
Standard Deviation .11
|
.05 percentage of alcohol/100 ml of blood
Standard Deviation .11
|
|
Blood Alcohol Concentration
6 Month Follow-Up
|
.09 percentage of alcohol/100 ml of blood
Standard Deviation .15
|
.07 percentage of alcohol/100 ml of blood
Standard Deviation .15
|
PRIMARY outcome
Timeframe: Baseline, 1 month follow-up, and 6-month follow upPopulation: One participant was removed from the analyses due to unreliable reporting
Heavy Episodic Drinking is defined as having 5 or more drinks in a row for males and 3 or more for females in a 2 hour period in the past month. The number of drinks was based on research by Donovan (2009) establishing cut-points for children and adolescents. Participants were asked: "Males: Think back over the last two weeks. How many times have you had 5 or more drinks in a two hour period?" "Females: Think back over the last two weeks. How many times have you had 3 or more drinks in a two hour period?" Minimum = 0; Maximum = none Sample score range: Minimum = 0; Maximum = .76 Higher scores are worse outcomes
Outcome measures
| Measure |
eCHECKUP TO GO
n=173 Participants
Brief, web-based alcohol intervention
eCHECKUP TO GO: eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking
|
Control
n=137 Participants
Assessment only
|
|---|---|---|
|
Heavy Episodic Drinking
Baseline
|
.89 binge drinking events
Standard Deviation 1.32
|
.61 binge drinking events
Standard Deviation 1.32
|
|
Heavy Episodic Drinking
1 Month Follow-Up
|
.73 binge drinking events
Standard Deviation 1.37
|
.52 binge drinking events
Standard Deviation 1.14
|
|
Heavy Episodic Drinking
6 Month Follow-Up
|
.66 binge drinking events
Standard Deviation 1.23
|
.49 binge drinking events
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline and 6-month follow upPopulation: One participant was removed from the analyses due to unreliable reporting
Rutgers Alcohol Problems Inventory Alcohol-related consequences were measured using the Rutgers Alcohol Problems Inventory. The Rutgers Alcohol Problems Inventory is a 23-item scale. Participants were asked "How many times have the following scenarios happened to you while you were consuming alcohol or as a result of your drinking in the past 30 days." Responses were measured on a 5-point scale ranging from 0 (never) to 4 (more than 10 times). A total consequence score is created by summing the 23 items. Minimum = 0; Maximum = 92 Sample score range: Minimum = 0; Maximum = 24 Higher scores are worse outcomes
Outcome measures
| Measure |
eCHECKUP TO GO
n=173 Participants
Brief, web-based alcohol intervention
eCHECKUP TO GO: eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking
|
Control
n=137 Participants
Assessment only
|
|---|---|---|
|
Alcohol-Related Consequences
Baseline
|
3.62 score on a scale
Standard Deviation 5.52
|
2.35 score on a scale
Standard Deviation 4.89
|
|
Alcohol-Related Consequences
6 Month Follow-Up
|
2.70 score on a scale
Standard Deviation 4.97
|
1.45 score on a scale
Standard Deviation 2.80
|
Adverse Events
eCHECKUP TO GO
Control
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