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Alcohol Feedback, Reflection and Morning Evaluation

Daily Personalized Drinking Feedback Delivered Via Mobile Phone

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05509218
Acronym
(A-FRAME)
Enrollment
152
Registered
2022-08-22
Start date
2024-08-26
Completion date
2025-10-28
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Youth Drinking

Keywords

young adults, personalized feedback intervention, mobile intervention, alcohol use

Brief summary

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.

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.

Interventions

BEHAVIORALMobile-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.

Sponsors

Brown University
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Participants are randomized to one of three conditions: (1) daily surveys plus personalized feedback about yesterday's drinking, with a monetary incentive for survey completion, (2) daily surveys plus personalized feedback about yesterday's drinking, with no monetary incentive, or (3) survey assessment (baseline and follow-up) only

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Drinks Per Week Post-testpost-test (1 month following baseline; end of intervention period for those in intervention groups)drinks per week in the past 30 days
Heavy Drinking Frequency Post-testpost-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
Negative Alcohol Consequences Post-testpost-test (end of 4-week intervention)Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
Drinks Per Week 3-month Follow-up3 month follow-up (4 months following baseline)drinks per week in the past 30 days
Heavy Drinking Frequency 3-month Follow-up3 month follow-up (4 months post-baseline)Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days
Negative Alcohol Consequences 3-month Follow-up3-month follow-up (3 months after end of intervention; 4 months after baselineNumber of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJennifer E Merrill, PhD

Brown University

Participant flow

Recruitment details

Participants were recruited via social media advertisements, outreach to participants from prior studies with documented interest in future studies, and a university listserv. Recruitment occurred between August 2024 and June 2025.

Baseline characteristics

Characteristic
Age, Continuous23.28 Years
STANDARD_DEVIATION 2.92
drinks per week17.06 drinks per week
STANDARD_DEVIATION 11.82
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
50 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
heavy drinking frequency6.96 days
STANDARD_DEVIATION 5.92
negative consequences8.53 consequences
STANDARD_DEVIATION 4.27
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
27 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
White
96 Participants
Sex: Female, Male
Female
29 Participants
Sex: Female, Male
Male
22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 540 / 520 / 46
other
Total, other adverse events
0 / 540 / 520 / 46
serious
Total, serious adverse events
0 / 540 / 520 / 46

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026