Motivating Campus Change Study
MC2
2 other identifiers
interventional
1,012
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedStudy Start
First participant enrolled
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedDecember 12, 2024
December 1, 2024
4.9 years
June 5, 2019
December 8, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (5)
Alcohol Use on New Years Eve
2 days
Alcohol Use during Spring Break
10 days
Alcohol Use on 4th of July
4 days
Alcohol Use on Halloween
4 days
Alcohol Use during Birthday
10 days
Study Arms (5)
Sequential Post Feedback Information Delivery
EXPERIMENTALParticipants 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.
Sequential Post Feedback Information Delivery +Text Messages
EXPERIMENTALParticipants 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).
Simultaneous Post Feedback Information Delivery
EXPERIMENTALParticipants 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.
Simultaneous Post Feedback Information Delivery +Text Messages
EXPERIMENTALParticipants 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).
Assessment Only Control
NO INTERVENTIONParticipants complete baseline survey, longitudinal follow up assessments, and pre- and post- event surveys.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unwillingness to participate
- Failure to provide consent
- Plan to travel internationally in the next 12 months (for intervention text purposes)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Center for the Study of Health and Risk Behaviors
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary E Larimer, PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, School of Medicine: Psychiatry And Behavioral Sciences
Study Record Dates
First Submitted
June 5, 2019
First Posted
July 23, 2019
Study Start
November 6, 2019
Primary Completion
September 30, 2024
Study Completion
June 30, 2025
Last Updated
December 12, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share