- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07036198
- Original Trial
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
Enrolling by invitation
Conditions
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
Interventional
Enrollment (Estimated)
250
Phase
- 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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
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
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
|
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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.
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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
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
Investigators
- 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)
June 29, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
April 8, 2025
First Submitted That Met QC Criteria
June 16, 2025
First Posted (Actual)
June 25, 2025
Study Record Updates
Last Update Posted (Actual)
July 14, 2026
Last Update Submitted That Met QC Criteria
July 12, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.