Drinking BehaviorMC2NCT04030325
Motivating Campus Change Study
A study testing Sequential Personalized Feedback Intervention Delivery, Simultaneous Personalized Feedback Intervention Delivery and Text Message Boosters in people with Drinking Behavior, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Drinking Behavior
- What is being tested?
- Sequential Personalized Feedback Intervention Delivery, Simultaneous Personalized Feedback Intervention Delivery and Text Message Boosters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,012 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for the Study of Health and Risk Behaviors
Seattle, Washington, 98105
About this 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.
Read the 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.
- Conditions
- Drinking Behavior
- Being tested
- Sequential Personalized Feedback Intervention Delivery, Simultaneous Personalized Feedback Intervention Delivery, Text Message Boosters
- Medical subject headings
- Drinking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential Personalized Feedback Intervention DeliveryBehavioural
Sequential PFI delivery over 3 weeks after baseline survey
Simultaneous Personalized Feedback Intervention DeliveryBehavioural
Simultaneous PFI delivery after baseline survey
Text Message BoostersBehavioural
Text message boosters on PFI content during week of high risk drinking events
| Study group | Role | What they receive |
|---|---|---|
| Sequential Post Feedback Information Delivery | Experimental | 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. Receives: Behavioral: Sequential Personalized Feedback Intervention Delivery |
| Sequential Post Feedback Information Delivery +Text Messages | Experimental | 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). Receives: Behavioral: Sequential Personalized Feedback Intervention Delivery; Behavioral: Text Message Boosters |
| Simultaneous Post Feedback Information Delivery | Experimental | 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. Receives: Behavioral: Simultaneous Personalized Feedback Intervention Delivery |
| Simultaneous Post Feedback Information Delivery +Text Messages | Experimental | 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). Receives: Behavioral: Simultaneous Personalized Feedback Intervention Delivery; Behavioral: Text Message Boosters |
| Assessment Only Control | No intervention | Participants complete baseline survey, longitudinal follow up assessments, and pre- and post- event surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months of assessment
Secondary outcomes (5)
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
Measured: 2 days
Alcohol Use during Spring Break
We will assess differences between arms on alcohol use during the 10 days of Spring Break
Measured: 10 days
Alcohol Use on 4th of July
We will assess differences between arms on alcohol use during 4 days surrounding 4th of July
Measured: 4 days
Alcohol Use on Halloween
We will assess differences between arms on alcohol use during 4 days surrounding Halloween
Measured: 4 days
Alcohol Use during Birthday
We will assess differences between arms on alcohol use during 10 days surrounding the participant's birthday
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start6 Nov 2019
- Primary completion30 Sep 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drinking BehaviorStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Mary Larimer, University of Washington
- Investigators
- Mary E Larimer, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030325
- Sponsor's protocol ID
- STUDY00007499
- Other IDs
- R37AA012547-11A1
- Acronym
- MC2
- Status last verified
- Dec 2024
- First submitted
- 5 Jun 2019
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Campus Change Study
- ClinicalTrials.gov ID
- NCT04030325
- Acronym / sponsor ID
- MC2 / STUDY00007499
- Conditions
- Drinking Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sequential Post Feedback Information Delivery | Experimental | Behavioral: Sequential Personalized Feedback Intervention DeliveryParticipants 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 | Experimental | Behavioral: Sequential Personalized Feedback Intervention Delivery, Behavioral: Text Message BoostersParticipants 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 | Experimental | Behavioral: Simultaneous Personalized Feedback Intervention DeliveryParticipants 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 | Experimental | Behavioral: Simultaneous Personalized Feedback Intervention Delivery, Behavioral: Text Message BoostersParticipants 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 intervention | –Participants complete baseline survey, longitudinal follow up assessments, and pre- and post- event surveys. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequential Personalized Feedback Intervention DeliverySequential PFI delivery over 3 weeks after baseline survey | Behavioural | Sequential Post Feedback Information Delivery, Sequential Post Feedback Information Delivery +Text Messages |
| Simultaneous Personalized Feedback Intervention DeliverySimultaneous PFI delivery after baseline survey | Behavioural | Simultaneous Post Feedback Information Delivery, Simultaneous Post Feedback Information Delivery +Text Messages |
| Text Message BoostersText message boosters on PFI content during week of high risk drinking events | Behavioural | Sequential Post Feedback Information Delivery +Text Messages, Simultaneous Post Feedback Information Delivery +Text Messages |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
Alcohol Use on New Years Eve
Time frame: 2 days
Alcohol Use during Spring Break
Time frame: 10 days
Alcohol Use on 4th of July
Time frame: 4 days
Alcohol Use on Halloween
Time frame: 4 days
Alcohol Use during Birthday
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E Larimer, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential Personalized Feedback Intervention Delivery, Simultaneous Personalized Feedback Intervention Delivery and Text Message Boosters in people with Drinking Behavior, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Alcohol Use at 6 months (time frame: 6 months of assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.