An interventional study of Sequential Personalized Feedback Intervention Delivery and Simultaneous Personalized Feedback Intervention Delivery in Drinking Behavior, sponsored by University of Washington. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by University of Washington · Not applicable, Interventional, and Prevention
The study evaluates the relative merit of a multi-component PFI presented in the traditional simultaneous delivery (i.e., all components at once) versus a sequential format, wherein individual PFI components are delivered one at a time over several weeks to minimize time and attention demands for each component.
This study builds upon the latest alcohol intervention literature to develop and test the next wave of personalized feedback interventions (PFIs) to address harmful alcohol use among college students. The purpose of this research is to determine optimal configuration of PFIs to take advantage of the clarity and initial impact of single-component PFIs and greater effect size and duration of personalized multi-component PFIs. The Investigators seek to increase and evaluate engagement with the PFI and text-message materials and boost innovation of both content and process of the intervention. In addition to PFI content and delivery, the investigators will use qualitative and quantitative methods to determine personal relevance of the chosen high-risk events among a sample of students who engage in heavy episodic drinking to better understand duration of PFI effects impacted by fluctuations in drinking associated with high-risk events. Prior interventions have targeted drinking in general or a single high-risk drinking event (e.g., Spring Break), but have not targeted both general and event-specific drinking together. These enhanced intervention effects, could have a significant impact on risks associated with college student drinking, and can be rapidly disseminated and implemented on campuses nationwide to address the public health problem posed by heavy episodic drinking among college students.
50 studies on the registry are indexed under Drinking Behavior; 6 are open to participants now.
This study's enrollment of 1,012 is above the median of 124 across 45 interventional studies indexed under Drinking Behavior.
Browse Drinking Behavior studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Exclusion Criteria:
Participants receive the first component of their PFI immediately following Baseline and subsequently receive 1 component each week until they receive all 4 components. Participants will complete a Post Feedback Survey and a 3 week follow back and Knowledge assessment.
Behavioral: Sequential Personalized Feedback Intervention Delivery
Participants receive the first component of their PFI immediately following Baseline and subsequently receive 1 component each week until they receive all 4 components. Participants will complete a Post Feedback Survey and a 3 week follow back and Knowledge assessment. Additionally, participants receive the Text Message Booster Component in the days before and during the high risk drinking event celebration(s).
Behavioral: Sequential Personalized Feedback Intervention Delivery · Behavioral: Text Message Boosters
Participants receive all 4 feedback components immediately after providing consent to the Pilot Feasibility Study following the Screening/Baseline Survey. Participants complete a brief 10 minute Post-Feedback Survey and a 3 Week Followup Survey to assess knowledge of the intervention feedback content.
Behavioral: Simultaneous Personalized Feedback Intervention Delivery
Participants receive all 4 feedback components immediately after providing consent to the Pilot Feasibility Study following the Screening/Baseline Survey. Participants complete a brief 10 minute Post-Feedback Survey and a 3 Week Followup Survey to assess knowledge of the intervention feedback content. Additionally, participants receive the Text Message Booster Component in the days before and during the high risk drinking event celebration(s).
Behavioral: Simultaneous Personalized Feedback Intervention Delivery · Behavioral: Text Message Boosters
Participants complete baseline survey, longitudinal follow up assessments, and pre- and post- event surveys.
Sequential PFI delivery over 3 weeks after baseline survey
Simultaneous PFI delivery after baseline survey
Text message boosters on PFI content during week of high risk drinking events
Change from Baseline Alcohol Use at 6 months
The first primary outcome of this program of research is to assess change in alcohol use from baseline to 6 months utilizing the Daily Drinking Questionnaire. The Daily Drinking Questionnaire assesses typical number of drinks on each of day of a typical week in the past month. Participants are allowed to enter the number of drinks for each day of the week. Values for each day will be summed together to create a composite score of typical weekly drinking. Minimum value is zero (0) and there is no maximum for the scale. Data will be assessed for outliers.
Time frame: 6 months of assessment
Change from Baseline Alcohol Use at 12 months
The second primary outcome of this program of research is to assess change in alcohol use from baseline to 12 months utilizing the Daily Drinking Questionnaire. The Daily Drinking Questionnaire assesses typical number of drinks on each of day of a typical week in the past month. Participants are allowed to enter the number of drinks for each day of the week. Values for each day will be summed together to create a composite score of typical weekly drinking. Minimum value is zero (0) and there is no maximum for the scale. Data will be assessed for outliers.
Time frame: 12 months of assessment
Change from Baseline Alcohol Use at 18 months
The third primary outcome of this program of research is to assess change in alcohol use from baseline to 18 months utilizing the Daily Drinking Questionnaire. The Daily Drinking Questionnaire assesses typical number of drinks on each of day of a typical week in the past month. Participants are allowed to enter the number of drinks for each day of the week. Values for each day will be summed together to create a composite score of typical weekly drinking. Minimum value is zero (0) and there is no maximum for the scale. Data will be assessed for outliers.
Time frame: 18 months of assessment
Change from Baseline Alcohol Use at 24 months
The fourth primary outcome of this program of research is to assess change in alcohol use from baseline to 24 months utilizing the Daily Drinking Questionnaire. The Daily Drinking Questionnaire assesses typical number of drinks on each of day of a typical week in the past month. Participants are allowed to enter the number of drinks for each day of the week. Values for each day will be summed together to create a composite score of typical weekly drinking. Minimum value is zero (0) and there is no maximum for the scale. Data will be assessed for outliers.
Time frame: 24 months of assessment
Alcohol Use on New Years Eve
We will assess differences between arms on alcohol use on New Year's Eve and New Year's Day
Time frame: 2 days
Alcohol Use during Spring Break
We will assess differences between arms on alcohol use during the 10 days of Spring Break
Time frame: 10 days
Alcohol Use on 4th of July
We will assess differences between arms on alcohol use during 4 days surrounding 4th of July
Time frame: 4 days
Alcohol Use on Halloween
We will assess differences between arms on alcohol use during 4 days surrounding Halloween
Time frame: 4 days
Alcohol Use during Birthday
We will assess differences between arms on alcohol use during 10 days surrounding the participant's birthday
Time frame: 10 days
Plan to share: No
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This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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