Motivating Campus Change Study

Drinking Behavior Clinical Trial

— MC2  

Official title:

Motivating Campus Change Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04030325
• Other study ID #: STUDY00007499
• Secondary ID: R37AA012547-11A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 6, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1012
• Est. completion date: June 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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)

Related Conditions & MeSH terms

• Drinking Behavior

Intervention

Behavioral:
• Sequential Personalized Feedback Intervention Delivery
Sequential PFI delivery over 3 weeks after baseline survey
• Simultaneous Personalized Feedback Intervention Delivery
Simultaneous PFI delivery after baseline survey
• Text Message Boosters
Text message boosters on PFI content during week of high risk drinking events

Locations

Country	Name	City	State
United States	The Center for the Study of Health and Risk Behaviors	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Alcohol Use during Spring Break	We will assess differences between arms on alcohol use during the 10 days of Spring Break	10 days
Secondary	Alcohol Use on 4th of July	We will assess differences between arms on alcohol use during 4 days surrounding 4th of July	4 days
Secondary	Alcohol Use on Halloween	We will assess differences between arms on alcohol use during 4 days surrounding Halloween	4 days
Secondary	Alcohol Use during Birthday	We will assess differences between arms on alcohol use during 10 days surrounding the participant's birthday	10 days