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Feedback, PsychologicalEPICNCT03087630

Evaluating Personalized Information and Choices

A study testing Reasoned-Based Intervention, Social-Based Intervention and Integrated Intervention in people with Feedback, Psychological and Underage Alcohol Use, run by University of Washington.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 20 yearsHealthy volunteers can take part
What is being tested?
Reasoned-Based Intervention, Social-Based Intervention and Integrated Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,204 participants
Where
No sites listed yet
Study dates
Mar 2015to 26 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18-20 years old
  • Not in high school
  • Reside within the US
  • Have a valid email address
  • 18-20 years old
  • Not in high school
Show all 12Show fewer
  • 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

Who cannot join

  • There are no exclusion criteria other than not meeting inclusion criteria
  • Study 2 Inclusion \& Exclusion Criteria
  • There are no exclusion criteria other than not meeting inclusion criteria

About this study

Official title: Informing Alcohol-Related Risk Intervention With the Prototype Willingness Model: Evaluating Personalized Information and Choices

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.

Read the detailed description

Purpose

This research is designed to evaluate a personalized feedback intervention for alcohol-related risky sexual behavior in a longitudinal study of underage young adult drinkers aged 18-20. The intervention is theoretically based on the Prototype Willingness Model (PW Model). The Prototype Willingness Model assumes two pathways to risk behavior: one pathway that is reasoned and one pathway that is socially based. Prior research has shown that interventions consistent with, or based on, components of the Prototype Willingness Model, are efficacious at reducing alcohol use and risky sexual behavior.

The investigators will evaluate the overall efficacy of the interventions based on the PW Model by comparing underage young adult drinkers randomly assigned to receive the reasoned-based pathway intervention (n=300), the social-based pathway intervention (n=300), or the integrated intervention based on the full PW Model (both pathways; n=300) to an attention control group (n=300). The investigators will examine whether intervention efficacy at reducing alcohol-related risky sexual behavior is mediated by reductions in drinking and changes in components of both the reasoned and social pathways (e.g., changes in attitudes, injunctive and descriptive normative perceptions, behavioral intention, perceived vulnerability, prototype favorability, and behavioral willingness). Past behavior and college student status will be evaluated as moderators of intervention efficacy. The investigators will also examine whether effects of all three interventions are maintained across the study follow-up period.

Procedures

This study consists of two phases. Phase 1 consists of a one-time online survey for the purpose of collecting normative data to be used in the personalized feedback intervention in Phase 2. Phase 2 will include an online screening, baseline assessment, and personalized feedback intervention, followed by four follow-up assessments.

Initial recruitment procedures for Phase 1 and 2 follow the same protocol. In both phases, young people who view study advertisements and choose to log-on to the study website view a brief information statement and, upon providing consent, proceed to a brief online screening survey containing questions regarding their basic demographics and contact information and questions necessary for determining eligibility, detailed below. Those who complete the survey and meet online eligibility are told that participants will be contacted by phone within 3 business days by research staff to explain the study and determine eligibility (e.g., age verification). During the 5 minute telephone screen, potential participants are given more information about the study and have their age verified by research staff. Previously reported demographics (age, DOB, etc.) from the online screening survey are cross checked for data consistency. Once investigators verify age and other screening criteria participants are given the option to receive a link via e-mail with more information about the study (i.e., information statement) and to participate in the web-survey. Upon completion of the telephone screen, interested and eligible participants are emailed a link to the one-time assessment (for Phase 1) or the baseline assessment (for Phase 2), as well as a unique PIN in a separate email. Each of these surveys begins with a full information statement, to which participants can indicate consent and begin the assessment. Those who begin but do not complete the assessment are contacted via email and telephone. If at any time a participant indicates unwillingness to continue, no further contact will ensue.

The Phase 1 one-time assessment is a 30-45-minute survey which consists of questions focusing on alcohol-related risky sexual behavior and injunctive and descriptive normative perceptions regarding alcohol-related risky sex behavior in others. Participants who complete this assessment are paid with a gift certificate, emailed within 2 weeks of completing the survey.

For Phase 2, the 30-45-minute baseline survey will consist of questions similar to the Phase 1 survey. Upon completion of the baseline assessment, participants will be randomized to one of four conditions: reasoned-based pathway intervention (n=300), social-based pathway intervention (n=300), integrated intervention (based on both pathways; n=300), or an attention control group (n=300). Participants randomized to an intervention condition will receive web-based graphic personalized feedback that will be imbedded into an interactive web-based assessment. The control condition will receive attention control feedback. The feedback is non-confrontational in tone, seeks to increase motivation to reduce alcohol-related risky sexual behavior, and is based on information provided during the baseline assessment. Participants will be able to view the feedback online and print it after viewing the entire feedback, or can click to request that a copy be mailed to them. All personalized feedback interventions will be tailored based on sexual orientation where appropriate.

Follow-up assessments will occur 3, 6, 9, and 12 months after baseline and will follow the same protocol and include the same measures. Participants will be emailed an invitation with a link to the survey and a separate PIN email

Participants will be paid with gift certificate for each assessment completed, and will also be eligible for entry into a drawing at each assessment. Gift certificates will be e-mailed to the participant within 2 weeks of completing the survey.

Subjects

Phase 1 Participants will include approximately 1,000 young adults aged 18-20, who live in the United States and who complete a one-time online assessment.

Phase 2 Participants will include 1,200 young adults aged 18-20, who live in the United States and who complete the baseline survey.

Being tested
Reasoned-Based Intervention, Social-Based Intervention, Integrated Intervention, Attention Control
Medical subject headings
Underage Drinking, Risk-Taking, Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reasoned-Based InterventionBehavioural

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

  • Social-Based InterventionBehavioural

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

  • Integrated InterventionBehavioural

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

  • Attention ControlBehavioural

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

Study groups in NCT03087630
Study groupRoleWhat they receive
Reasoned-Based InterventionExperimentalReceives reason-based intervention.
Receives: Behavioral: Reasoned-Based Intervention
Social-Based InterventionExperimentalReceives social-based intervention.
Receives: Behavioral: Social-Based Intervention
Integrated InterventionExperimentalReceives integrated intervention.
Receives: Behavioral: Integrated Intervention
Attention ControlExperimentalReceives attention control feedback.
Receives: Behavioral: Attention Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups

  2. 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.

    Measured: Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups

  3. 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.

    Measured: Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups

  4. 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.

    Measured: Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups

  5. 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.

    Measured: Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2017
  2. Study startMar 2015
  3. Primary completion26 Mar 2018
  4. Study completion26 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03087630
Sponsor's protocol ID
44051
Acronym
EPIC
Status last verified
May 2018
First submitted
8 Mar 2017
Last updated
18 May 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: A select number of researchers will have access to unidentified participant data at the close of the study.

Questions about this trial

What is this clinical trial studying?

A study testing Reasoned-Based Intervention, Social-Based Intervention and Integrated Intervention in people with Feedback, Psychological and Underage Alcohol Use, run by University of Washington.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Frequency of Drinking Prior to Sex (time frame: Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.

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