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Motivating Campus Change Study (MC2)

Primary Purpose

Drinking Behavior

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sequential Personalized Feedback Intervention Delivery
Simultaneous Personalized Feedback Intervention Delivery
Text Message Boosters
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drinking Behavior

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • The Center for the Study of Health and Risk Behaviors

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Sequential Post Feedback Information Delivery

Sequential Post Feedback Information Delivery +Text Messages

Simultaneous Post Feedback Information Delivery

Simultaneous Post Feedback Information Delivery +Text Messages

Assessment Only Control

Arm Description

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.

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).

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.

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).

Participants complete baseline survey, longitudinal follow up assessments, and pre- and post- event surveys.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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
Alcohol Use during Spring Break
We will assess differences between arms on alcohol use during the 10 days of Spring Break
Alcohol Use on 4th of July
We will assess differences between arms on alcohol use during 4 days surrounding 4th of July
Alcohol Use on Halloween
We will assess differences between arms on alcohol use during 4 days surrounding Halloween
Alcohol Use during Birthday
We will assess differences between arms on alcohol use during 10 days surrounding the participant's birthday

Full Information

First Posted
June 5, 2019
Last Updated
June 12, 2023
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04030325
Brief Title
Motivating Campus Change Study
Acronym
MC2
Official Title
Motivating Campus Change Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drinking Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1012 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequential Post Feedback Information Delivery
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequential Post Feedback Information Delivery +Text Messages
Arm Type
Experimental
Arm Description
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).
Arm Title
Simultaneous Post Feedback Information Delivery
Arm Type
Experimental
Arm Description
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.
Arm Title
Simultaneous Post Feedback Information Delivery +Text Messages
Arm Type
Experimental
Arm Description
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).
Arm Title
Assessment Only Control
Arm Type
No Intervention
Arm Description
Participants complete baseline survey, longitudinal follow up assessments, and pre- and post- event surveys.
Intervention Type
Behavioral
Intervention Name(s)
Sequential Personalized Feedback Intervention Delivery
Intervention Description
Sequential PFI delivery over 3 weeks after baseline survey
Intervention Type
Behavioral
Intervention Name(s)
Simultaneous Personalized Feedback Intervention Delivery
Intervention Description
Simultaneous PFI delivery after baseline survey
Intervention Type
Behavioral
Intervention Name(s)
Text Message Boosters
Intervention Description
Text message boosters on PFI content during week of high risk drinking events
Primary Outcome Measure Information:
Title
Change from Baseline Alcohol Use at 6 months
Description
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
Title
Change from Baseline Alcohol Use at 12 months
Description
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
Title
Change from Baseline Alcohol Use at 18 months
Description
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
Title
Change from Baseline Alcohol Use at 24 months
Description
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
Secondary Outcome Measure Information:
Title
Alcohol Use on New Years Eve
Description
We will assess differences between arms on alcohol use on New Year's Eve and New Year's Day
Time Frame
2 days
Title
Alcohol Use during Spring Break
Description
We will assess differences between arms on alcohol use during the 10 days of Spring Break
Time Frame
10 days
Title
Alcohol Use on 4th of July
Description
We will assess differences between arms on alcohol use during 4 days surrounding 4th of July
Time Frame
4 days
Title
Alcohol Use on Halloween
Description
We will assess differences between arms on alcohol use during 4 days surrounding Halloween
Time Frame
4 days
Title
Alcohol Use during Birthday
Description
We will assess differences between arms on alcohol use during 10 days surrounding the participant's birthday
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E Larimer, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for the Study of Health and Risk Behaviors
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Motivating Campus Change Study

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