CPNF Intervention Development and Testing (Project SHIFT)

July 12, 2026 updated by: Mary Larimer, University of Washington

A User-Customizable Personalized Normative Feedback Intervention for Alcohol Harm Reduction in Young Adults: Feasibility, Acceptability, and Preliminary Efficacy

The project will develop brief interventions that allow participants to customize which groups they receive feedback for in relation to things such as drinking norms for younger or older students, student athletes, etc. The goal is to provide content that is meaningful and engaging to all users.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The project will develop and pilot test an innovative paradigm for leveraging social norms within brief interventions that entails user customization of which (and how many) normative referent groups they receive feedback for so that the content is meaningful and engaging to all users.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mary Larimer, Ph.D.
  • Phone Number: 206-543-3513
  • Email: larimer@uw.edu

Study Contact Backup

  • Name: Ty Tristao, BA
  • Phone Number: (564) 225-2468
  • Email: tt88@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • The University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Enrolled at the University of Washington either part- or full-time
  • Report 3 or more past-month drinking occasions
  • Report 3 or more drinks per occasion in the past month, on average
  • Report 4 or more drinks during the peak drinking occasion in the past month
  • Pass attention-check items

Exclusion Criteria:

N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: CPNF
Customizable personalized normative feedback (CPNF) intervention whereby individuals can explore normative feedback for a wider variety of referent groups so that PNF is a truly personalized and engaging experience.
Behavioral: Customizable personalized normative feedback (CPNF)
The CPNF intervention allows individuals to explore normative feedback for a wider variety of referent groups so that PNF is a truly personalized and engaging experience.
Active Comparator: standard PNF
Standard personalized normative feedback.
Behavioral: Personalized normative feedback (PNF)
Correcting misperceptions about peers' alcohol use behaviors and contrasting one's own use to the actual norms of their peers.
Active Comparator: Attention-Matched Control (AMC)
Attention-matched control.
Behavioral: Attention-Matched Control (AMC)
Participants in the AMC condition will complete all measures at the same time as participants in the CPNF condition but will not receive any information on drinking norms. Instead, participants in the AMC will receive normative feedback on sleep health, video game use, and gambling behaviors, and will similarly be able to choose the normative referent groups they wish to view feedback on for these behaviors. The AMC will thus serve as a non-treatment comparison that controls for assessment reactivity and effects of history and maturation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alcohol use - drinks per month
Time Frame: Screening, Baseline, Follow-ups, an average of 3 months
Daily Drinking Questionnaire will assess drinks on average over the past month by recording the number of drinks consumed on each day of a typical week. Response options range from 0 drinks to 25+ drinks. Lower score is a better outcome, higher score is a worse outcome.
Screening, Baseline, Follow-ups, an average of 3 months
Alcohol use - Quantity per occasion
Time Frame: Screening, Baseline, Follow-ups, an average of 3 months
Quantity/Frequency/Peak Alcohol Use Index will assess amount of alcohol consumed over the past month with how many days alcohol was consumed, average consumption, and peak consumption. Response options range from 0 to 30 days for frequency, and 1 to 12+ drinks for quantity and peak. Lower score is a better outcome, higher score is a worse outcome.
Screening, Baseline, Follow-ups, an average of 3 months
Alcohol use - Heavy episodic drinking
Time Frame: Screening, Baseline, Follow-ups, an average of 3 months
Heavy Episodic Drinking measure will assess how many times over the past month heavy drinking episodes occurred, defined as 4 or more drinks (females) or 5 or more drinks (males) on a single occasion. Response options range from 0 to 7 days. Lower score is a better outcome, higher score is a worse outcome.
Screening, Baseline, Follow-ups, an average of 3 months
Alcohol use - Peak drinks & peak BAC
Time Frame: Screening, Baseline, Follow-ups, an average of 3 months
Electronic Blood Alcohol content will be assessed and calculated using peak drinks over x amount of time. A lower BAC is a better outcome, a higher BAC is a worse outcome.
Screening, Baseline, Follow-ups, an average of 3 months
Alcohol use - Alcohol Use Disorders Identification Test
Time Frame: Baseline, Follow-ups, an average of 3 months
The AUDIT is a 10-item self-report screening tool assessing hazardous and harmful alcohol use over the past year. Items are rated on varying 5-point Likert-type scales assessing frequency, quantity, and consequences of alcohol use. Lower score is a better outcome, higher score is a worse outcome.
Baseline, Follow-ups, an average of 3 months
Alcohol use - Brief Young Adult Alcohol Consequences Questionnaire
Time Frame: Baseline, Follow-ups, an average of 3 months
The Brief YAACQ is a 24-item assessment of alcohol-related consequences in young adults. Response options for the items are yes or no. Higher score (i.e. more 'yes' responses) is a worse outcome, lower score (i.e. more 'no' responses) is a better outcome.
Baseline, Follow-ups, an average of 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived descriptive norms for each normative referent group
Time Frame: Baseline, Follow-ups, an average of 3 months
Gathered via Shortened Drinking Norms Rating Form. 7 items assess belief for what's an acceptable number of drinks each day of the week with responses ranging from 0 to 25+ drinks.
Baseline, Follow-ups, an average of 3 months
Perceived injunctive drinking norms for typical students at UW
Time Frame: Baseline, Follow-ups, an average of 3 months
Gathered via the Injunctive Drinking Norms Rating Form. 7 items assess belief for what a typical UW college student drinks on each day of each day of the week with responses ranging from 0 to 25+ drinks.
Baseline, Follow-ups, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mary Larimer, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00021161
  • R34AA031336 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All scientific data (qualitative interview transcriptions, survey response data) will be both preserved and shared. Data will be made publicly available to the research community. This will include but may not be limited to (a) semi-structured interview questions, (b) survey items and corresponding response options (including missingness coding), (c) a codebook for scoring survey items and composite scales, (d) a detailed description of internally computed variables (e.g., time spent viewing intervention content), and (e) documentation of intervention components that participants were exposed to (both treatment and control conditions). Public use and restricted access study data and associated documentation will be made available to the research community free of charge through the NIAAA Data Archive.

IPD Sharing Time Frame

Data will be shared with the general research community at the time of an associated publication, or the end of the award/support period, whichever comes first.

IPD Sharing Access Criteria

The data will be made available for sharing with the general research community via the NDA website. Investigators at institutions with a Federal Wide Assurance (FWA) will be able to gain access to NDA data by submitting a data access request in accordance with applicable NDA policies.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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