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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02918565
Other study ID # STUDY19050262
Secondary ID R01AA023650
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date November 22, 2021

Study information

Verified date November 2023
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A 5-arm randomized trial to determine what components of a text message intervention are necessary to reduce hazardous drinking among young adults and mechanisms through which these changes occur.


Description:

Young adults ages 18-25 have high rates of hazardous alcohol use and alcohol-related consequences. The Emergency Department (ED) provides an important opportunity to identify young adult hazardous drinkers who could benefit from interventions. A Text Message (TM) intervention was shown to reduce alcohol consumption among young adult ED patients, showing durable effects over 9-months. The TM intervention uses behavior change techniques with the largest effect sizes in an alcohol intervention meta-analysis: "goal commitment" and "self-monitoring", along with real-time "feedback". However, the unique effect of these ingredients, and mechanisms (processes occurring within the individual) through which they operate to reduce drinking remain unclear, a critical gap addressed by this project. Young adult ED patients (ages 18-25) who screen positive for hazardous drinking will be recruited to participate in a randomized trial to determine how best to help individuals reduce hazardous drinking. All participants will be asked to complete web-based surveys at baseline, 12 and 24 weeks after enrollment, complete brief psychomotor tasks weekly for 14 weeks, and respond to text messages each Thursday and Sunday for the next 12 weeks. Those randomized to the TM interventions will additionally receive feedback on their text reports. The four TM intervention arms are: (1) Drinking Cognition Feedback (DCF), (2) Alcohol Risk Feedback (ARF), (3) Adaptive Goal Support (AGS) and (4) a combination of DCF, ARF, and AGS=COMBO). Study results have implications for designing efficient mobile interventions, and developing a dynamic theory of behavior change.


Recruitment information / eligibility

Status Completed
Enrollment 1131
Est. completion date November 22, 2021
Est. primary completion date November 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - total score of >2 for women or >3 for men on the AUDIT-C - at least 1 binged drinking episode in the prior 30 days Exclusion Criteria: - no cell phone with text messaging - have been diagnosed with an alcohol or substance use disorder - pregnant or planning pregnancy - taking medicine for a psychiatric disorder (including depression, anxiety) - taking any medicine that could interact with alcohol

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Drinking Cognition Feedback (DCF)
12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk).
Alcohol Risk Feedback (ARF)
12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend).
Adaptive Goal Support (AGS)
12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed).
COMBO
12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS.

Locations

Country Name City State
United States University of Pittsburgh Medical Center Emergency Department Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh 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 Number of Binge Drinking Days Measured by the # days on the Timeline Followback Calendar that a male reported 5+ drinks or a female reported 4+ drinks 12 weeks after starting intervention
Secondary Drinks Per Drinking Day drinks per drinking day = mean drinks divided by the number of days with any alcohol consumption using the 30-day TLFB Calendar. 12 weeks after starting intervention
Secondary Count of Participants With Any Binge Drinking Day Using the Timeline Followback Calendar, any male participant reported one or more days with 5+ drinks or a female with one or more days with 4+ drinks are coded=1; otherwise participant is coded=0 12 weeks after starting intervention
Secondary Brief Young Adult Alcohol Consequences Questionnaire Score Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ). The B-YAACQ is a 24-item measure of alcohol- related problems that utilizes a dichotomous (present or absent) scoring format. Sum of items 1-48. Higher scores (count of items marked as 'present') on the B-YAACQ not only indicate a wider variety but also reflect a more severe pattern of alcohol-related problems. 12 weeks after starting intervention
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