- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03613818
Efficacy of a Web-Based Alcohol Intervention for High School Students
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Idaho
-
Boise, Idaho, United States, 83725
- Boise State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Senior enrolled in high school sites
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: eCHECKUP TO GO
Brief, web-based alcohol intervention
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weekly Drinking
Time Frame: 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 |
Baseline, 1 month follow-up, and 6-month follow up
|
Peak Drinking Quantity
Time Frame: 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 |
Baseline, 1 month follow-up, and 6-month follow up
|
Frequency of Alcohol Use
Time Frame: 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 |
Baseline, 1 month follow-up, and 6-month follow up
|
Blood Alcohol Concentration
Time Frame: 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 |
Baseline, 1 month follow-up, and 6-month follow up
|
Heavy Episodic Drinking
Time Frame: 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 |
Baseline, 1 month follow-up, and 6-month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol-Related Consequences
Time Frame: 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 |
Baseline and 6-month follow up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Diana Doumas, PhD, Boise State Univeristy
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 023880
- R21AA023880 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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