Risk-Taking Clinical Trial
— EPICOfficial title:
Informing Alcohol-Related Risk Intervention With the Prototype Willingness Model: Evaluating Personalized Information and Choices
NCT number | NCT03087630 |
Other study ID # | 44051 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | March 26, 2018 |
Verified date | May 2018 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research examines a theoretically informed web-based personalized feedback intervention to reduce alcohol-related risky sexual behavior among young adult drinkers. To accomplish this objective the study has enrolled a national sample of 1200 young adults aged 18-20 and is in the process of assessing them at 3-, 6-, 9-, and 12-months. The investigators will evaluate the overall efficacy of the interventions based on the Prototype Willingness Model by comparing underage young adult drinkers randomly assigned to receive the reason-based pathway intervention (n=300), the social-based pathway intervention (n=300), or the integrated intervention based on the full Prototype Willingness Model (both pathways, n=300) to an attention control group (n=300). The investigators will examine whether changes in components of both the reasoned and social pathways and drinking mediate intervention efficacy on reducing alcohol-related risky sexual behavior. Past behavior and college student status will be evaluated as moderators of intervention efficacy. The proposed study is both significant and innovative in that it will evaluate brief interventions among a national sample of young adults attending and not attending college, will utilize social networking sites for participant recruitment, and will test the efficacy of interventions based on individual and integrated pathways of the Prototype Willingness Model.
Status | Completed |
Enrollment | 1204 |
Est. completion date | March 26, 2018 |
Est. primary completion date | March 26, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 20 Years |
Eligibility |
Study 1 Inclusion & Exclusion Criteria Inclusion Criteria: - 18-20 years old - Not in high school - Reside within the US - Have a valid email address Exclusion Criteria: - There are no exclusion criteria other than not meeting inclusion criteria Study 2 Inclusion & Exclusion Criteria Inclusion Criteria: - 18-20 years old - Not in high school - Reside within the US - Have a valid email address - Not currently in monogamous relationship - Drink at least two times per week - Have had sex at least once within the past 3 months - Did not participate in Phase 1 Exclusion Criteria: - There are no exclusion criteria other than not meeting inclusion criteria |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Frequency of Drinking Prior to Sex | Assesses frequency of drinking prior to sex at the baseline, 3-, 6-, 9-, and 12-month time points. | Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups | |
Primary | Change in Typical Number of Drinks Consumed Prior to Sex | Assesses typical number of drinks consumed prior to sex at the baseline, 3-, 6-, 9-, and 12-month time points. | Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups | |
Primary | Change in Total Number of Sex Partners Involving Alcohol | Assesses total number of sex partners involving alcohol at the baseline, 3-, 6-, 9-, and 12-month time points. | Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups | |
Primary | Change in Total Number of Casual Sex Partners Involving Alcohol | Assesses total number of casual sex partners involving alcohol at the baseline, 3-, 6-, 9-, and 12-month time points. | Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups | |
Primary | Change in Frequency of Condom Use During Sex Involving Alcohol | Assesses frequency of condom use during sex involving alcohol at the baseline, 3-, 6-, 9-, and 12-month time points. | Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups |
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