Motivating Campus Change Study (MC2)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Drinking Behavior
• Intervention / Treatment: Behavioral: Sequential Personalized Feedback Intervention Delivery; Behavioral: Text Message Boosters; Behavioral: Simultaneous Personalized Feedback Intervention Delivery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1012
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • The Center for the Study of Health and Risk Behaviors

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Mary E Larimer, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior
• Other Study ID Numbers: STUDY00007499; R37AA012547-11A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No