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

Primary Purpose

Youth Drinking, Alcohol Drinking

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile-delivered personalized feedback
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Youth Drinking focused on measuring young adults, personalized feedback intervention, mobile intervention, alcohol use

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Personalized feedback plus incentive

    Personalized feedback without incentive

    Control

    Arm Description

    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.

    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.

    Participants in this arm will only complete baseline and follow-up surveys.

    Outcomes

    Primary Outcome Measures

    drinks per week
    Number of drinks consumed per typical week in the past 30 days
    heavy drinking frequency
    Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days
    negative alcohol consequences
    Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)

    Secondary Outcome Measures

    Full Information

    First Posted
    August 18, 2022
    Last Updated
    July 21, 2023
    Sponsor
    Brown University
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05509218
    Brief Title
    Alcohol Feedback, Reflection and Morning Evaluation
    Acronym
    (A-FRAME)
    Official Title
    Daily Personalized Drinking Feedback Delivered Via Mobile Phone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    January 31, 2025 (Anticipated)
    Study Completion Date
    July 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Brown University
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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. 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. Randomization. Randomization will occur following consent. The pilot 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. 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. 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Youth Drinking, Alcohol Drinking
    Keywords
    young adults, personalized feedback intervention, mobile intervention, alcohol use

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    170 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Personalized feedback plus incentive
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Personalized feedback without incentive
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Participants in this arm will only complete baseline and follow-up surveys.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mobile-delivered personalized feedback
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    drinks per week
    Description
    Number of drinks consumed per typical week in the past 30 days
    Time Frame
    post-test (end of 4-week intervention) and 3-month follow-up (3 months after end of intervention)
    Title
    heavy drinking frequency
    Description
    Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days
    Time Frame
    post-test (end of 4-week intervention) and 3-month follow-up (3 months after end of intervention)
    Title
    negative alcohol consequences
    Description
    Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
    Time Frame
    post-test (end of 4-week intervention) and 3-month follow-up (3 months after end of intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    29 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jennifer E Merrill, PhD
    Phone
    401-863-5165
    Email
    jennifer_merrill@brown.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifer E Merrill, PhD
    Organizational Affiliation
    Brown University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    This study will submit and share data with NIAAA Data Archive, a data repository housed within the NIMH 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.

    Learn more about this trial

    Alcohol Feedback, Reflection and Morning Evaluation

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