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Motivating Campus Change Study

Motivating Campus Change Study

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04030325
Acronym
MC2
Enrollment
1012
Registered
2019-07-23
Start date
2019-11-06
Completion date
2025-06-30
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drinking Behavior

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.

Interventions

BEHAVIORALSequential Personalized Feedback Intervention Delivery

Sequential PFI delivery over 3 weeks after baseline survey

BEHAVIORALSimultaneous Personalized Feedback Intervention Delivery

Simultaneous PFI delivery after baseline survey

Text message boosters on PFI content during week of high risk drinking events

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Alcohol Use at 6 months6 months of assessmentThe 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 months12 months of assessmentThe 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 months18 months of assessmentThe 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 months24 months of assessmentThe 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

MeasureTime frameDescription
Alcohol Use on New Years Eve2 daysWe will assess differences between arms on alcohol use on New Year's Eve and New Year's Day
Alcohol Use during Birthday10 daysWe will assess differences between arms on alcohol use during 10 days surrounding the participant's birthday
Alcohol Use during Spring Break10 daysWe will assess differences between arms on alcohol use during the 10 days of Spring Break
Alcohol Use on 4th of July4 daysWe will assess differences between arms on alcohol use during 4 days surrounding 4th of July
Alcohol Use on Halloween4 daysWe will assess differences between arms on alcohol use during 4 days surrounding Halloween

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026