Alcohol UseProject SHIFTNCT07036198
CPNF Intervention Development and Testing
A study testing Customizable personalized normative feedback (CPNF) and Personalized normative feedback (PNF) in people with Alcohol Use, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Alcohol Use
- What is being tested?
- Customizable personalized normative feedback (CPNF) and Personalized normative feedback (PNF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Washington
Seattle, Washington, 98195
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use
- Being tested
- Customizable personalized normative feedback (CPNF), Personalized normative feedback (PNF), Attention-Matched Control (AMC)
- Keywords
- young adults, alcohol-related harm, RCT, normative feedback
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customizable personalized normative feedback (CPNF)Behavioural
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.
Personalized normative feedback (PNF)Behavioural
Correcting misperceptions about peers' alcohol use behaviors and contrasting one's own use to the actual norms of their peers.
Attention-Matched Control (AMC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CPNF | Active comparator | 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. Receives: Behavioral: Customizable personalized normative feedback (CPNF) |
| standard PNF | Active comparator | Standard personalized normative feedback. Receives: Behavioral: Personalized normative feedback (PNF) |
| Attention-Matched Control (AMC) | Active comparator | Attention-matched control. Receives: Behavioral: Attention-Matched Control (AMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use - drinks per month
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.
Measured: Screening, Baseline, Follow-ups, an average of 3 months
Alcohol use - Quantity per occasion
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.
Measured: Screening, Baseline, Follow-ups, an average of 3 months
Alcohol use - Heavy episodic drinking
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.
Measured: Screening, Baseline, Follow-ups, an average of 3 months
Alcohol use - Peak drinks & peak BAC
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.
Measured: Screening, Baseline, Follow-ups, an average of 3 months
Alcohol use - Alcohol Use Disorders Identification Test
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.
Measured: Baseline, Follow-ups, an average of 3 months
Alcohol use - Brief Young Adult Alcohol Consequences Questionnaire
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.
Measured: Baseline, Follow-ups, an average of 3 months
Secondary outcomes (2)
Perceived descriptive norms for each normative referent group
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.
Measured: Baseline, Follow-ups, an average of 3 months
Perceived injunctive drinking norms for typical students at UW
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.
Measured: Baseline, Follow-ups, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start29 Jun 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol UseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Mary Larimer, University of Washington
- Investigators
- Mary Larimer, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036198
- Sponsor's protocol ID
- STUDY00021161
- Other IDs
- R34AA031336
- Acronym
- Project SHIFT
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A User-Customizable Personalized Normative Feedback Intervention for Alcohol Harm Reduction in Young Adults: Feasibility, Acceptability, and Preliminary Efficacy
- ClinicalTrials.gov ID
- NCT07036198
- Acronym / sponsor ID
- Project SHIFT / STUDY00021161
- Conditions
- Alcohol Use
- Keywords
- young adults, alcohol-related harm, RCT, normative feedback
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 25 Jun 2025 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPNF | Active comparator | Behavioral: Customizable personalized normative feedback (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. |
| standard PNF | Active comparator | Behavioral: Personalized normative feedback (PNF)Standard personalized normative feedback. |
| Attention-Matched Control (AMC) | Active comparator | Behavioral: Attention-Matched Control (AMC)Attention-matched control. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| 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. | Behavioural | CPNF |
| Personalized normative feedback (PNF)Correcting misperceptions about peers' alcohol use behaviors and contrasting one's own use to the actual norms of their peers. | Behavioural | standard PNF |
| 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. | Behavioural | Attention-Matched Control (AMC) |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Perceived descriptive norms for each normative referent group
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Mary Larimer, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customizable personalized normative feedback (CPNF) and Personalized normative feedback (PNF) in people with Alcohol Use, run by University of Washington at 1 site in United States.
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 5 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Alcohol use - drinks per month (time frame: Screening, Baseline, Follow-ups, an average of 3 months). The study lists 6 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 14 Jul 2026.