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

Primary Purpose

Underage Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eCHECKUP TO GO
Sponsored by
Boise State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Underage Drinking

Eligibility Criteria

16 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Senior enrolled in high school sites

Exclusion Criteria:

  • none

Sites / Locations

  • Boise State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

eCHECKUP TO GO

Control

Arm Description

Brief, web-based alcohol intervention

Assessment only

Outcomes

Primary Outcome Measures

Weekly Drinking
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
Peak Drinking Quantity
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
Frequency of Alcohol Use
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
Blood Alcohol Concentration
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
Heavy Episodic Drinking
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

Alcohol-Related Consequences
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

Full Information

First Posted
July 30, 2018
Last Updated
March 5, 2021
Sponsor
Boise State University
Collaborators
National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03613818
Brief Title
Efficacy of a Web-Based Alcohol Intervention for High School Students
Official Title
Efficacy of a Web-Based Alcohol Intervention for High School Students
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boise State University
Collaborators
National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Underage Drinking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eCHECKUP TO GO
Arm Type
Experimental
Arm Description
Brief, web-based alcohol intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
Assessment only
Intervention Type
Behavioral
Intervention Name(s)
eCHECKUP TO GO
Intervention Description
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
Primary Outcome Measure Information:
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
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
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
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
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Senior enrolled in high school sites Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Doumas, PhD
Organizational Affiliation
Boise State Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boise State University
City
Boise
State/Province
Idaho
ZIP/Postal Code
83725
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32359042
Citation
Doumas DM, Esp S, Turrisi R, Bond L, Flay B. Efficacy of the eCHECKUP TO GO for High School Seniors: Sex Differences in Risk Factors, Protective Behavioral Strategies, and Alcohol Use. J Stud Alcohol Drugs. 2020 Mar;81(2):135-143. doi: 10.15288/jsad.2020.81.135.
Results Reference
result
PubMed Identifier
34347564
Citation
Doumas DM, Esp S, Turrisi R, Bond L. A Randomized Controlled Trial of the eCHECKUP to GO for High School Seniors across the Academic Year. Subst Use Misuse. 2021;56(13):1923-1932. doi: 10.1080/10826084.2021.1958862. Epub 2021 Aug 4.
Results Reference
derived

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

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