Efficacy of a Web-Based Alcohol Intervention for High School Students

• Sponsor: Boise State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03613818
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 311
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 47.8

Study Details

Study Description

Brief Summary

This study evaluates the efficacy of the eCHECKUP TO GO as an intervention to reduce underage drinking and the associated negative consequences among high school seniors. The aim of this project is to provide a brief, low cost intervention that can be easily disseminated as a school-based intervention to address this important public health problem.

Condition or Disease	Intervention/Treatment	Phase
Underage Drinking	Behavioral: eCHECKUP TO GO	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 311 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Efficacy of a Web-Based Alcohol Intervention for High School Students
• Actual Study Start Date: Sep 15, 2018
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: eCHECKUP TO GO Brief, web-based alcohol intervention	Behavioral: 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
No Intervention: Control Assessment only

Outcome Measures

Primary Outcome Measures

1. Weekly Drinking [Baseline, 1 month follow-up, and 6-month follow up]

   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

2. Peak Drinking Quantity [Baseline, 1 month follow-up, and 6-month follow up]

   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

3. Frequency of Alcohol Use [Baseline, 1 month follow-up, and 6-month follow up]

   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

4. Blood Alcohol Concentration [Baseline, 1 month follow-up, and 6-month follow up]

   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

5. Heavy Episodic Drinking [Baseline, 1 month follow-up, and 6-month follow up]

   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

Secondary Outcome Measures

1. Alcohol-Related Consequences [Baseline and 6-month follow up]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Senior enrolled in high school sites

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boise State University	Boise	Idaho	United States	83725

Sponsors and Collaborators

• Boise State University
• National Institutes of Health (NIH)
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Diana Doumas, PhD, Boise State Univeristy

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 27, 2021

More Information

Publications

None provided.

• Responsible Party: Diana Doumas, Distinguished Professor, Boise State University
• ClinicalTrials.gov Identifier: NCT03613818
• Other Study ID Numbers: 023880; R21AA023880
• First Posted: Aug 3, 2018
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Underage Drinking

Study Results

Participant Flow

Arm/Group Title	eCHECKUP TO GO	Control
Arm/Group Description	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	Assessment only
Period Title: Overall Study
STARTED	174	137
COMPLETED	137	110
NOT COMPLETED	37	27

Baseline Characteristics

Arm/Group Title	eCHECKUP TO GO	Control	Total
Arm/Group Description	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	Assessment only	Total of all reporting groups
Overall Participants	174	137	311
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	17.13 (0.46)	17.13 (0.45)	17.13 (0.45)
Sex: Female, Male (Count of Participants)
Female	100 57.5%	73 53.3%	173 55.6%
Male	74 42.5%	64 46.7%	138 44.4%
Race/Ethnicity, Customized (Count of Participants)
White	152 87.4%	112 81.8%	264 84.9%
Hispanic/Latino	6 3.4%	9 6.6%	15 4.8%
Asian	7 4%	7 5.1%	14 4.5%
Black/African-American	1 0.6%	4 2.9%	5 1.6%
American Indian/Alaska Native	2 1.1%	2 1.5%	4 1.3%
Native Hawaiian/Pacific Islander	2 1.1%	0 0%	2 0.6%
Other	4 2.3%	3 2.2%	7 2.3%
Region of Enrollment (participants) [Number]
United States	174 100%	137 100%	311 100%

Outcome Measures

1. Primary Outcome

Title	Weekly Drinking
Description	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
Time Frame	Baseline, 1 month follow-up, and 6-month follow up

Outcome Measure Data

Analysis Population Description

One participant was removed from the analyses due to unreliable reporting

Arm/Group Title	eCHECKUP TO GO	Control
Arm/Group Description	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	Assessment only
Measure Participants	173	137
Basline	4.14 (6.74)	3.06 (6.39)
1 Month Follow-Up	2.92 (4.93)	2.55 (5.32)
6 Month Follow-Up	2.23 (3.94)	2.14 (5.04)

2. Primary Outcome

Title	Peak Drinking Quantity
Description	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
Time Frame	Baseline, 1 month follow-up, and 6-month follow up

Outcome Measure Data

Analysis Population Description

One participant was removed from the analyses due to unreliable reporting

Arm/Group Title	eCHECKUP TO GO	Control
Arm/Group Description	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	Assessment only
Measure Participants	173	137
Baseline	5.10 (6.01)	2.81 (5.13)
1 Month Follow-Up	3.65 (4.48)	2.53 (4.89)
6 Month Follow-Up	3.63 (4.86)	2.40 (4.58)

3. Primary Outcome

Title	Frequency of Alcohol Use
Description	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
Time Frame	Baseline, 1 month follow-up, and 6-month follow up

Outcome Measure Data

Analysis Population Description

One participant was removed from the analyses due to unreliable reporting

Arm/Group Title	eCHECKUP TO GO	Control
Arm/Group Description	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	Assessment only
Measure Participants	173	137
Baseline	3.71 (1.94)	2.84 (1.91)
1 Month Follow-Up	3.61 (1.89)	2.72 (1.81)
6 Month Follow-Up	3.41 (1.80)	2.62 (1.77)

4. Primary Outcome

Title	Blood Alcohol Concentration
Description	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
Time Frame	Baseline, 1 month follow-up, and 6-month follow up

Outcome Measure Data

Analysis Population Description

One participant was removed from the analyses due to unreliable reporting

Arm/Group Title	eCHECKUP TO GO	Control
Arm/Group Description	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	Assessment only
Measure Participants	173	137
Baseline	.11 (.16)	.06 (.11)
1 Month Follow-Up	.07 (.11)	.05 (.11)
6 Month Follow-Up	.09 (.15)	.07 (.15)

5. Primary Outcome

Title	Heavy Episodic Drinking
Description	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
Time Frame	Baseline, 1 month follow-up, and 6-month follow up

Outcome Measure Data

Analysis Population Description

One participant was removed from the analyses due to unreliable reporting

Arm/Group Title	eCHECKUP TO GO	Control
Arm/Group Description	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	Assessment only
Measure Participants	173	137
Baseline	.89 (1.32)	.61 (1.32)
1 Month Follow-Up	.73 (1.37)	.52 (1.14)
6 Month Follow-Up	.66 (1.23)	.49 (1.22)

6. Secondary Outcome

Title	Alcohol-Related Consequences
Description	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
Time Frame	Baseline and 6-month follow up

Outcome Measure Data

Analysis Population Description

One participant was removed from the analyses due to unreliable reporting

Arm/Group Title	eCHECKUP TO GO	Control
Arm/Group Description	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	Assessment only
Measure Participants	173	137
Baseline	3.62 (5.52)	2.35 (4.89)
6 Month Follow-Up	2.70 (4.97)	1.45 (2.80)

Adverse Events

Time Frame	6 months
Arm/Group Title	eCHECKUP TO GO		Control
Arm/Group Description	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		Assessment only
All Cause Mortality
	eCHECKUP TO GO		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/174 (0%)		0/137 (0%)
Serious Adverse Events
	eCHECKUP TO GO		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/174 (0%)		0/137 (0%)
Other (Not Including Serious) Adverse Events
	eCHECKUP TO GO		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/174 (0%)		0/137 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.