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.
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
- Conditions the study is for
- Feedback, Psychological, Underage Alcohol Use, Risk-Taking
- What is being tested?
- Reasoned-Based Intervention, Social-Based Intervention and Integrated Intervention
- Type of treatment
- Lifestyle or therapy programme
- 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 group | Role | What they receive |
|---|---|---|
| Reasoned-Based Intervention | Experimental | Receives reason-based intervention. Receives: Behavioral: Reasoned-Based Intervention |
| Social-Based Intervention | Experimental | Receives social-based intervention. Receives: Behavioral: Social-Based Intervention |
| Integrated Intervention | Experimental | Receives integrated intervention. Receives: Behavioral: Integrated Intervention |
| Attention Control | Experimental | Receives attention control feedback. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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.
- First posted22 Mar 2017
- Study startMar 2015
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feedback, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Lewis, University of Washington
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.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informing Alcohol-Related Risk Intervention With the Prototype Willingness Model: Evaluating Personalized Information and Choices
- ClinicalTrials.gov ID
- NCT03087630
- Acronym / sponsor ID
- EPIC / 44051
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,204 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reasoned-Based Intervention | Experimental | Behavioral: Reasoned-Based InterventionReceives reason-based intervention. |
| Social-Based Intervention | Experimental | Behavioral: Social-Based InterventionReceives social-based intervention. |
| Integrated Intervention | Experimental | Behavioral: Integrated InterventionReceives integrated intervention. |
| Attention Control | Experimental | Behavioral: Attention ControlReceives attention control feedback. |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 18-20 years old
- Not in high school
- Reside within the US
- Have a valid email address
- 18-20 years old
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reasoned-Based InterventionReceives personalized feedback based on the reasoned pathway of the Prototype Willingness Model. | Behavioural | Reasoned-Based Intervention |
| Social-Based InterventionReceives personalized feedback based on the social pathway of the Prototype Willingness Model. | Behavioural | Social-Based Intervention |
| Integrated InterventionReceives personalized feedback based on both the reasoned and social pathways of the Prototype Willingness Model. | Behavioural | Integrated Intervention |
| Attention ControlReceives personalized feedback related to nutrition and exercise, unrelated to drinking behavior. | Behavioural | Attention Control |
Primary outcome
Change in Frequency of Drinking Prior to Sex
Time frame: Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups
Assesses frequency of drinking prior to sex at the baseline, 3-, 6-, 9-, and 12-month time points.
Change in Typical Number of Drinks Consumed Prior to Sex
Time frame: Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups
Assesses typical number of drinks consumed prior to sex at the baseline, 3-, 6-, 9-, and 12-month time points.
Change in Total Number of Sex Partners Involving Alcohol
Time frame: Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups
Assesses total number of sex partners involving alcohol at the baseline, 3-, 6-, 9-, and 12-month time points.
Change in Total Number of Casual Sex Partners Involving Alcohol
Time frame: Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups
Assesses total number of casual sex partners involving alcohol at the baseline, 3-, 6-, 9-, and 12-month time points.
Change in Frequency of Condom Use During Sex Involving Alcohol
Time frame: Baseline, 3-, 6-, 9-, and 12-Month Follow-Ups
Assesses frequency of condom use during sex involving alcohol at the baseline, 3-, 6-, 9-, and 12-month time points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Individual participant dataSharing planned: No. A select number of researchers will have access to unidentified participant data at the close of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.