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OpenTrials
Active, Not Recruiting

NCT Number: NCT04030325

Motivating Campus Change Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Drinking Behavior Behavior

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Center for the Study of Health and Risk Behaviors

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sequential Personalized Feedback Intervention Delivery

Behavioral

Sequential PFI delivery over 3 weeks after baseline survey

Simultaneous Personalized Feedback Intervention Delivery

Behavioral

Simultaneous PFI delivery after baseline survey

Text Message Boosters

Behavioral

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

Primary outcomes

  1. Change from Baseline Alcohol Use at 6 months

    Time frame: 6 months of assessment

    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.

  2. Change from Baseline Alcohol Use at 12 months

    Time frame: 12 months of assessment

    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.

  3. Change from Baseline Alcohol Use at 18 months

    Time frame: 18 months of assessment

    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.

  4. Change from Baseline Alcohol Use at 24 months

    Time frame: 24 months of assessment

    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 outcomes

  1. Alcohol Use on New Years Eve

    Time frame: 2 days

    We will assess differences between arms on alcohol use on New Year's Eve and New Year's Day

  2. Alcohol Use during Spring Break

    Time frame: 10 days

    We will assess differences between arms on alcohol use during the 10 days of Spring Break

  3. Alcohol Use on 4th of July

    Time frame: 4 days

    We will assess differences between arms on alcohol use during 4 days surrounding 4th of July

  4. Alcohol Use on Halloween

    Time frame: 4 days

    We will assess differences between arms on alcohol use during 4 days surrounding Halloween

  5. Alcohol Use during Birthday

    Time frame: 10 days

    We will assess differences between arms on alcohol use during 10 days surrounding the participant's birthday

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: MC2

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Jul 23, 2019
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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