Drinking BehaviorMC2 PilotNCT03962751
Motivating Campus Change Project Pilot Study
A study testing Simultaneous Post Feedback Intervention Delivery, Sequential Post 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
This study tests the optimization and delivery feasibility of personalized feedback interventions to address harmful alcohol use among college students. 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?
- Simultaneous Post Feedback Intervention Delivery, Sequential Post 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
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 4 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- birthday that falls withing summer/ fall 2018 assessment window
- 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
- intend to consume alcohol over the week of their birthday
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motivating Campus Change (MC2) Project Pilot Study
This study tests the optimization and delivery feasibility of personalized feedback interventions to address harmful alcohol use among college students.
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.
This study conducts a screening/baseline assessment to collect quantitative data on high risk drinking situations and related norms and screens participants for eligibility for the Pilot Feasibility Study. The purpose of the Pilot Feasibility Study is to test the feasibility of sending participants web-based personalized feedback targeting their general drinking behavior in a single dose (Simultaneous) versus broken up into 4 components administered one week apart (Sequential) with half of participants in each group also being randomly selected to receive a text message booster component targeting drinking during their upcoming birthday celebration.
- Conditions
- Drinking Behavior
- Being tested
- Simultaneous Post Feedback Intervention Delivery, Sequential Post 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.
Simultaneous Post Feedback Intervention DeliveryBehavioural
Simultaneous PFI delivery after baseline survey
Sequential Post Feedback Intervention DeliveryBehavioural
Sequential PFI delivery over 3 weeks after baseline survey
Text Message BoostersBehavioural
Text message boosters on PFI content during week of high risk drinking event
| 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 Post 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 their birthday celebration(s). Receives: Behavioral: Sequential Post 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 Post 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 their birthday celebration(s). Receives: Behavioral: Simultaneous Post Feedback Intervention Delivery; Behavioral: Text Message Boosters |
| Baseline Assessment Only | No intervention | Participants complete baseline survey and conclude participation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with different modes of delivery of personalized information on health behaviors
The primary outcome of this program of research is to assess participant satisfaction of different modes of personalized information delivery. The participants receive personalized information related to health behaviors all at once or weekly over the course of 4 weeks and satisfaction is assessed using survey completion rates, tracked interaction with the personalized feedback information, and a series of satisfaction related questions.
Measured: 2-3 months of intervention assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start28 Jun 2018
- Primary completion4 Nov 2018
- Study completion4 Nov 2018
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
- 250 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
- NCT03962751
- Sponsor's protocol ID
- STUDY00004630
- Other IDs
- R01AA012547-11A1, R56AA012547-11A1
- Acronym
- MC2 Pilot
- Status last verified
- Dec 2020
- First submitted
- 8 May 2019
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Campus Change (MC2) Project Pilot Study
- ClinicalTrials.gov ID
- NCT03962751
- Acronym / sponsor ID
- MC2 Pilot / STUDY00004630
- Conditions
- Drinking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 4 Nov 2018 (actual)
- Study completion
- 4 Nov 2018 (actual)
- First posted
- 24 May 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.
This study tests the optimization and delivery feasibility of personalized feedback interventions to address harmful alcohol use among college students.
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.
This study conducts a screening/baseline assessment to collect quantitative data on high risk drinking situations and related norms and screens participants for eligibility for the Pilot Feasibility Study. The purpose of the Pilot Feasibility Study is to test the feasibility of sending participants web-based personalized feedback targeting their general drinking behavior in a single dose (Simultaneous) versus broken up into 4 components administered one week apart (Sequential) with half of participants in each group also being randomly selected to receive a text message booster component targeting drinking during their upcoming birthday celebration.
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 Post 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 Post 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 their birthday celebration(s). |
| Simultaneous Post Feedback Information Delivery | Experimental | Behavioral: Simultaneous Post 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 Post 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 their birthday celebration(s). |
| Baseline Assessment Only | No intervention | –Participants complete baseline survey and conclude participation. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- birthday that falls withing summer/ fall 2018 assessment window
- 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
- intend to consume alcohol over the week of their birthday
- Indicate they own a cell phone with text message capabilities and consent to receiving text messages
Key exclusion criteria (3 listed)
- Doesn't meet inclusion criteria
- Unwillingness to participate
- Failure to provide consent
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 |
|---|---|---|
| Simultaneous Post Feedback Intervention DeliverySimultaneous PFI delivery after baseline survey | Behavioural | Simultaneous Post Feedback Information Delivery, Simultaneous Post Feedback Information Delivery +Text Messages |
| Sequential Post Feedback Intervention DeliverySequential PFI delivery over 3 weeks after baseline survey | Behavioural | Sequential Post Feedback Information Delivery, Sequential Post Feedback Information Delivery +Text Messages |
| Text Message BoostersText message boosters on PFI content during week of high risk drinking event | Behavioural | Sequential Post Feedback Information Delivery +Text Messages, Simultaneous Post Feedback Information Delivery +Text Messages |
Primary outcome
Satisfaction with different modes of delivery of personalized information on health behaviors
Time frame: 2-3 months of intervention assessment
The primary outcome of this program of research is to assess participant satisfaction of different modes of personalized information delivery. The participants receive personalized information related to health behaviors all at once or weekly over the course of 4 weeks and satisfaction is assessed using survey completion rates, tracked interaction with the personalized feedback information, and a series of satisfaction related questions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
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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 Simultaneous Post Feedback Intervention Delivery, Sequential Post 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 16 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Satisfaction with different modes of delivery of personalized information on health behaviors (time frame: 2-3 months of intervention assessment). 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 16 Dec 2020.