Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT05509218
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2022-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alcohol Feedback, Reflection and Morning Evaluation
Sponsor:
Brown University
Organization:
Study Overview
Official Title:
Daily Personalized Drinking Feedback Delivered Via Mobile Phone
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
(A-FRAME)
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R34AA029733-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |