Motivating Campus Change Project Pilot Study

NCT ID: NCT03962751

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-28

Study Completion Date

2018-11-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study tests the optimization and delivery feasibility of personalized feedback interventions to address harmful alcohol use among college students.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Drinking Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sequential Post Feedback Information Delivery

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.

Group Type EXPERIMENTAL

Sequential Post Feedback Intervention Delivery

Intervention Type BEHAVIORAL

Sequential PFI delivery over 3 weeks after baseline survey

Sequential Post Feedback Information Delivery +Text Messages

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).

Group Type EXPERIMENTAL

Sequential Post Feedback Intervention Delivery

Intervention Type BEHAVIORAL

Sequential PFI delivery over 3 weeks after baseline survey

Text Message Boosters

Intervention Type BEHAVIORAL

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

Simultaneous Post Feedback Information Delivery

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.

Group Type EXPERIMENTAL

Simultaneous Post Feedback Intervention Delivery

Intervention Type BEHAVIORAL

Simultaneous PFI delivery after baseline survey

Simultaneous Post Feedback Information Delivery +Text Messages

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).

Group Type EXPERIMENTAL

Simultaneous Post Feedback Intervention Delivery

Intervention Type BEHAVIORAL

Simultaneous PFI delivery after baseline survey

Text Message Boosters

Intervention Type BEHAVIORAL

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

Baseline Assessment Only

Participants complete baseline survey and conclude participation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simultaneous Post Feedback Intervention Delivery

Simultaneous PFI delivery after baseline survey

Intervention Type BEHAVIORAL

Sequential Post Feedback Intervention Delivery

Sequential PFI delivery over 3 weeks after baseline survey

Intervention Type BEHAVIORAL

Text Message Boosters

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* Unwillingness to participate
* Failure to provide consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mary Larimer

Professor, School of Medicine, Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mary E Larimer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Washington

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AA012547-11A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R56AA012547-11A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004630

Identifier Type: -

Identifier Source: org_study_id