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Motivating Campus Change Project Pilot Study (MC2 Pilot)

Primary Purpose

Drinking Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simultaneous Post Feedback Intervention Delivery
Sequential Post Feedback Intervention Delivery
Text Message Boosters
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drinking Behavior

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Doesn't meet inclusion criteria
  • Unwillingness to participate
  • Failure to provide consent

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Sequential Post Feedback Information Delivery

Sequential Post Feedback Information Delivery +Text Messages

Simultaneous Post Feedback Information Delivery

Simultaneous Post Feedback Information Delivery +Text Messages

Baseline Assessment Only

Arm Description

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.

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).

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.

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).

Participants complete baseline survey and conclude participation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 8, 2019
Last Updated
December 14, 2020
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03962751
Brief Title
Motivating Campus Change Project Pilot Study
Acronym
MC2 Pilot
Official Title
Motivating Campus Change (MC2) Project Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
November 4, 2018 (Actual)
Study Completion Date
November 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drinking Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequential Post Feedback Information Delivery
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequential Post Feedback Information Delivery +Text Messages
Arm Type
Experimental
Arm Description
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).
Arm Title
Simultaneous Post Feedback Information Delivery
Arm Type
Experimental
Arm Description
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.
Arm Title
Simultaneous Post Feedback Information Delivery +Text Messages
Arm Type
Experimental
Arm Description
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).
Arm Title
Baseline Assessment Only
Arm Type
No Intervention
Arm Description
Participants complete baseline survey and conclude participation.
Intervention Type
Behavioral
Intervention Name(s)
Simultaneous Post Feedback Intervention Delivery
Intervention Description
Simultaneous PFI delivery after baseline survey
Intervention Type
Behavioral
Intervention Name(s)
Sequential Post Feedback Intervention Delivery
Intervention Description
Sequential PFI delivery over 3 weeks after baseline survey
Intervention Type
Behavioral
Intervention Name(s)
Text Message Boosters
Intervention Description
Text message boosters on PFI content during week of high risk drinking event
Primary Outcome Measure Information:
Title
Satisfaction with different modes of delivery of personalized information on health behaviors
Description
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.
Time Frame
2-3 months of intervention assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Doesn't meet inclusion criteria Unwillingness to participate Failure to provide consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E Larimer, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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Motivating Campus Change Project Pilot Study

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