NCT03962751

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

May 8, 2019

Last Update Submit

December 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    2-3 months of intervention assessment

Study Arms (5)

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.

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).

Behavioral: Sequential Post Feedback Intervention DeliveryBehavioral: 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.

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).

Behavioral: Simultaneous Post Feedback Intervention DeliveryBehavioral: Text Message Boosters

Baseline Assessment Only

NO INTERVENTION

Participants complete baseline survey and conclude participation.

Interventions

Simultaneous PFI delivery after baseline survey

Simultaneous Post Feedback Information DeliverySimultaneous Post Feedback Information Delivery +Text Messages

Sequential PFI delivery over 3 weeks after baseline survey

Sequential Post Feedback Information DeliverySequential Post Feedback Information Delivery +Text Messages

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

Sequential Post Feedback Information Delivery +Text MessagesSimultaneous Post Feedback Information Delivery +Text Messages

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Unwillingness to participate
  • Failure to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Drinking Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Mary E Larimer, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine, Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 24, 2019

Study Start

June 28, 2018

Primary Completion

November 4, 2018

Study Completion

November 4, 2018

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations