Motivating Campus Change Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Motivating Campus Change Study

Conditions
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Drinking Behavior

Intervention / Treatment
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* Behavioral: Sequential Personalized Feedback Intervention Delivery
* Behavioral: Simultaneous Personalized Feedback Intervention Delivery
* Behavioral: Text Message Boosters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 1 heavy episodic drinking episode in the past month at least 3 negative alcohol related consequences on Rutgers Alcohol Problem Index/ Young Adult Alcohol Problems Screening Test in the past 3 months for cohort 1 at least 2 negative alcohol related consequences on Rutgers Alcohol Problem Index/ Young Adult Alcohol Problems Screening Test in the past month for cohort 2 - 5 Indicate they own a cell phone with text message capabilities and consent to receiving text messages Exclusion Criteria: Doesn't meet inclusion criteria Unwillingness to participate Failure to provide consent Plan to travel internationally in the next 12 months (for intervention text purposes)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential Post Feedback Information Delivery<br>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<br>* Sequential PFI delivery over 3 weeks after baseline survey<br>|
| Experimental: Sequential Post Feedback Information Delivery +Text Messages<br>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<br>* Sequential PFI delivery over 3 weeks after baseline survey<br>Behavioral: Text Message Boosters<br>* Text message boosters on PFI content during week of high risk drinking events<br>|
| Experimental: Simultaneous Post Feedback Information Delivery<br>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<br>* Simultaneous PFI delivery after baseline survey<br>|
| Experimental: Simultaneous Post Feedback Information Delivery +Text Messages<br>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<br>* Simultaneous PFI delivery after baseline survey<br>Behavioral: Text Message Boosters<br>* Text message boosters on PFI content during week of high risk drinking events<br>|
| No Intervention: Assessment Only Control<br>Participants complete baseline survey, longitudinal follow up assessments, and pre- and post- event surveys. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 24 months of assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 days | 
| Alcohol Use during Spring Break | We will assess differences between arms on alcohol use during the 10 days of Spring Break | 10 days | 
| Alcohol Use on 4th of July | We will assess differences between arms on alcohol use during 4 days surrounding 4th of July | 4 days | 
| Alcohol Use on Halloween | We will assess differences between arms on alcohol use during 4 days surrounding Halloween | 4 days | 
| Alcohol Use during Birthday | We will assess differences between arms on alcohol use during 10 days surrounding the participant's birthday | 10 days |