Evaluating Personalized Information and Choices

NCT03087630 | Completed

• 1 other identifier: 44051
• Study Type: interventional
• Target: 1,204
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Feedback, Psychological; Underage Alcohol Use; Risk-Taking; Sex Behavior

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

Reasoned-Based Intervention

EXPERIMENTAL

Receives reason-based intervention.

Behavioral: Reasoned-Based Intervention

Social-Based Intervention

EXPERIMENTAL

Receives social-based intervention.

Behavioral: Social-Based Intervention

Integrated Intervention

EXPERIMENTAL

Receives integrated intervention.

Behavioral: Integrated Intervention

Attention Control

EXPERIMENTAL

Receives attention control feedback.

Behavioral: Attention Control

Interventions

Reasoned-Based Intervention BEHAVIORAL

Receives personalized feedback based on the reasoned pathway of the Prototype Willingness Model.

Reasoned-Based Intervention

Social-Based Intervention BEHAVIORAL

Receives personalized feedback based on the social pathway of the Prototype Willingness Model.

Social-Based Intervention

Integrated Intervention BEHAVIORAL

Receives personalized feedback based on both the reasoned and social pathways of the Prototype Willingness Model.

Integrated Intervention

Attention Control BEHAVIORAL

Receives personalized feedback related to nutrition and exercise, unrelated to drinking behavior.

Attention Control

Eligibility Criteria

• Age: 18 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• years old
• Not in high school
• Reside within the US
• Have a valid email address
• 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

Sponsors & Collaborators

• University of Washington: lead

MeSH Terms

Conditions

Underage Drinking; Risk-Taking; Sexual Behavior

Condition Hierarchy (Ancestors)

Adolescent Behavior; Behavior; Alcohol Drinking; Drinking Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 22, 2017
• Study Start: March 1, 2015
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: May 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share