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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03962751
Other study ID # STUDY00004630
Secondary ID R01AA012547-11A1
Status Completed
Phase N/A
First received
Last updated
Start date June 28, 2018
Est. completion date November 4, 2018

Study information

Verified date December 2020
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date November 4, 2018
Est. primary completion date November 4, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Simultaneous Post Feedback Intervention Delivery
Simultaneous PFI delivery after baseline survey
Sequential Post Feedback Intervention Delivery
Sequential PFI delivery over 3 weeks after baseline survey
Text Message Boosters
Text message boosters on PFI content during week of high risk drinking event

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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