Alcohol Feedback, Reflection and Morning Evaluation ((A-FRAME))

June 15, 2026 updated by: Brown University

Daily Personalized Drinking Feedback Delivered Via Mobile Phone

The investigators propose to examine mornings after drinking as an optimal time to provide repeated, personalized feedback, with the goal of reducing hazardous drinking. Specifically, the investigators will further develop and pilot test a novel theory-based personalized feedback intervention (PFI) for heavy drinking young adults. Intervention strategies include personalized feedback (e.g., feedback on prior night blood alcohol concentration, consequences) contrasted with both drinking goals set at baseline and corrective normative feedback (e.g., how last night's drinking compares to peers). Up to 170 participants (50% non-college) will be randomized to one of three groups: PFI with monetary incentives for daily surveys, PFI without monetary incentives, or survey assessment only. The investigators will examine recruitment rates, retention rates, confirmation of intervention content delivery/intake, response rates to daily surveys, data quality, and ratings of intervention value. Investigators will test whether these indicators of engagement differ between those who do and do not receive monetary incentives for daily surveys. Further, baseline, post-test, and 3-month follow-up assessments will allow us to examine differences in drinking behavior between PFI and control. The results of the proposed research will result in a novel and scalable intervention for alcohol misuse among young adults, with potential to have an important impact on the public health problem of high-risk drinking.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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 investigators will recruit up to 170 participants for a small randomized controlled trial. Participants will be randomized to four weeks of intervention with or without daily incentives for completing surveys, or assessment-only control, to test feasibility, acceptability, and initial evidence of efficacy.

  1. Baseline assessment and orientation. An orientation meeting will be used to describe all study procedures and obtain informed consent. If informed consent is obtained, participants will then be given one week to complete a baseline survey (~30 minutes) on their own time, using their own computers. Data needed to personalize the intervention content will be collected during the baseline survey. Participants will be asked to choose from a range of possible goal types (e.g., max drinks per drinking event, drinks per week, weekly frequency of drinking, "skip goals", "delay goals", slow goals", "stop goals"). These goals an be integrated/contrasted with subsequent self-reported behavior on morning reports during the intervention period. After the baseline survey, a research assistant (RA) will review study procedures.
  2. Randomization. Randomization will occur following consent. The pilot randomized controlled trial (RCT) will include three conditions (mobile PFI with daily incentive for surveys, mobile PFI without daily incentives, assessment-only). PFI participants (both groups) will also complete (1) orientation and participant training (as described above), (2) four weeks of daily assessment and (3) intervention (as described below), and (4) follow-up surveys.
  3. Daily assessment. Daily assessment + feedback will begin on a Monday for all participants. A link to a web-based morning survey will be sent at 7am, and it will remain available until 2pm. When prior night alcohol use is endorsed, details will be assessed via single item measures about the drinking event.
  4. Personalized Feedback Reports. Following each daily survey on which a participant (in PFI groups) indicates prior day drinking, personalized feedback will be provided on how their most recent behavior (e.g., drinks last night, drinking days so far this week) compare/contrast with personal goals. Participants will then choose whether to receive additional feedback in any of 7 areas: blood alcohol concentration, high risk behaviors, consequences of drinking, caloric intake, spending, how drinking compares to peers, and safe drinking strategies. In addition to day-level feedback, an aggregate feedback report on drinking patterns and related behaviors will be delivered twice, once at the end of each 2-week period. At the end of the 2-week feedback report, participants in the intervention groups will have the opportunity to update/add goals for the next 2 weeks, given what they learned thus far about their personalized behavior-outcome links.
  5. Follow-up surveys. At the end of four weeks, participants in all three groups will complete a 30-minute online survey (post-intervention). The final 30-minute follow-up will take place three months after the end of intervention (four months after baseline) and will assess primary outcomes and mechanisms.

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 (Actual)

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.
152

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.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Brown University

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

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-29 years
  • Own a smartphone and use it daily
  • Heavy episodic drinking (4+/5+ drinks for women/men) at least weekly in past month
  • At least one of 10 negative consequences assessed
  • at least somewhat willing to consider drinking even a little less than current

Exclusion Criteria:

  • current participation in treatment for an alcohol or other substance use disorder
  • participation in an earlier phase of the study
  • enrollment in ongoing alcohol studies at the same university

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: None (Open Label)

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.
Experimental: Personalized feedback plus incentive
Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided. Participants in this group will receive $1 per day for submitting their daily survey.
Behavioral: Mobile-delivered personalized feedback
Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided on how their most recent behavior (e.g., drinks last night, drinking days so far this week) compare/contrast with personal goals. Participants will then choose whether to receive additional feedback in any of 7 areas: blood alcohol concentrate on, high risk behaviors, consequences of drinking, caloric intake, spending, how drinking compares to peers, and safe drinking strategies. All participants will receive feedback on drinks consumed, and then be asked to choose at least one additional topic for feedback (following each drinking day). In addition to day-level feedback, an aggregate feedback report on drinking patterns and related behaviors will be delivered twice, once at the end of each 2-week period. Once again, they will have the option to view feedback across the range of topics noted above.
Experimental: Personalized feedback without incentive
Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided. Participants in this group will NOT receive $1 per day for submitting their daily survey.
Behavioral: Mobile-delivered personalized feedback
Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided on how their most recent behavior (e.g., drinks last night, drinking days so far this week) compare/contrast with personal goals. Participants will then choose whether to receive additional feedback in any of 7 areas: blood alcohol concentrate on, high risk behaviors, consequences of drinking, caloric intake, spending, how drinking compares to peers, and safe drinking strategies. All participants will receive feedback on drinks consumed, and then be asked to choose at least one additional topic for feedback (following each drinking day). In addition to day-level feedback, an aggregate feedback report on drinking patterns and related behaviors will be delivered twice, once at the end of each 2-week period. Once again, they will have the option to view feedback across the range of topics noted above.
No Intervention: Control
Participants in this arm will only complete baseline and follow-up surveys.

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
Drinks Per Week Post-test
Time Frame: post-test (1 month following baseline; end of intervention period for those in intervention groups)
drinks per week in the past 30 days
post-test (1 month following baseline; end of intervention period for those in intervention groups)
Heavy Drinking Frequency Post-test
Time Frame: post-test (end of 4-week intervention for those in intervention groups, and 1 month after baseline)
Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days
post-test (end of 4-week intervention for those in intervention groups, and 1 month after baseline)
Negative Alcohol Consequences Post-test
Time Frame: post-test (end of 4-week intervention)
Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
post-test (end of 4-week intervention)
Drinks Per Week 3-month Follow-up
Time Frame: 3 month follow-up (4 months following baseline)
drinks per week in the past 30 days
3 month follow-up (4 months following baseline)
Heavy Drinking Frequency 3-month Follow-up
Time Frame: 3 month follow-up (4 months post-baseline)
Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days
3 month follow-up (4 months post-baseline)
Negative Alcohol Consequences 3-month Follow-up
Time Frame: 3-month follow-up (3 months after end of intervention; 4 months after baseline
Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
3-month follow-up (3 months after end of intervention; 4 months after baseline

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.
Brown University

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: Jennifer E Merrill, PhD, Brown University

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.
August 26, 2024

Primary Completion (Actual)

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.
October 28, 2025

Study Completion (Actual)

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.
October 28, 2025

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).
August 18, 2022

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.
August 18, 2022

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.
August 22, 2022

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.
June 16, 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.
June 15, 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.
March 1, 2025

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.
  • 2022003299
  • 1R34AA029733-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will submit and share data with NIAAA Data Archive, a data repository housed within the National Institute of Mental Health Data Archive (NDA). Participants complete a baseline survey of participant characteristics and drinking behavior and related constructs, a post-test survey, and a 3-month follow-up assessment to measure drinking behavior post-intervention. Data from these 3 surveys will be shared.

IPD Sharing Time Frame

Data will be shared on or before the NDA submission due dates (April 1 and October 1 each year). It will remain in the archive as per the archive regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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