Texting to Reduce Alcohol Misuse Pilot Trial (TRAM)
November 20, 2024 updated by: Brian Suffoletto, Stanford University
The primary aims of this project are to determine the feasibility and acceptability of recruiting and retaining young adult binge drinkers online and using text messaging to provide weekly Goal Support (GS) or weekly GS + Coaching for Context-specific Peer Support (CCPS) on alcohol consumption.
The secondary aims will determine effect sizes for GS and GS+CCPS groups relative to controls on alcohol consumption at 6- and 12-weeks to inform design of an adequately-powered trial.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Palo Alto, California, United States, 94301
- Stanford University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- English reader
- Owns a mobile phone with SMS
- Hazardous alcohol consumption as measured by: "How many times in the past year have you had X or more drinks in a day?", where X is 5 for men and 4 for women, and a response of 1 or greater is considered at-risk
- At least in contemplative stage of change for reducing alcohol consumption
Exclusion Criteria:
- Currently enrolled or past enrollment in a 4-year college
- Pregnant or pregnancy plans in the next 3-months
- Current or planned treatment for alcohol or substance use disorder in next 3-months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
Each week for 6-weeks, control group participants will receive the following weekly text message assessments (without receiving any feedback or support): (1) Thursdays (3pm): weekend plans to drink and desire to get drunk; (2) Sundays (12pm): most drinks consumed on any weekend day and peer pressure to drink.
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Each week for 6-weeks, control group participants will receive the following weekly text message assessments (without receiving any feedback or support): (1) Thursdays (3pm): weekend plans to drink and desire to get drunk; (2) Sundays (12pm): most drinks consumed on any weekend day and peer pressure to drink.
|
|
Experimental: Goal Support (GS)
Each week for 6-weeks, GS group participants will compete identical weekly text message assessments to the control group and receive further prompts and tailored feedback and support focused on weekly drinking limit goal commitment & confidence assessments and subsequently receive tailored feedback on goal success to either bolster future goal striving or reframe goal failure.
|
Each week for 6-weeks, control group participants will receive the following weekly text message assessments (without receiving any feedback or support): (1) Thursdays (3pm): weekend plans to drink and desire to get drunk; (2) Sundays (12pm): most drinks consumed on any weekend day and peer pressure to drink.
Each week for 6-weeks, GS group participants will receive prompts and tailored feedback and support focused on weekly drinking limit goal commitment & confidence assessments and subsequently receive tailored feedback on goal success to either bolster future goal striving or reframe goal failure.
|
|
Experimental: GS + Coaching for Context-specific Peer Support (CCPS)
Each week for 6-weeks, CCPS group participants will compete identical weekly text message assessments and feedback to GS plus additionally will receive weekly motivation and strategies to enlist peer support during drinking episodes.
|
Each week for 6-weeks, control group participants will receive the following weekly text message assessments (without receiving any feedback or support): (1) Thursdays (3pm): weekend plans to drink and desire to get drunk; (2) Sundays (12pm): most drinks consumed on any weekend day and peer pressure to drink.
Each week for 6-weeks, GS group participants will receive prompts and tailored feedback and support focused on weekly drinking limit goal commitment & confidence assessments and subsequently receive tailored feedback on goal success to either bolster future goal striving or reframe goal failure.
Each week for 6-weeks, CCPS group participants will receive weekly motivation and strategies to enlist peer support during drinking episodes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The % of people screened to participants enrolled
Time Frame: 2 months
|
Online recruitment efficiency
|
2 months
|
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The % of participants who complete both 6- and 12-week web-based assessments
Time Frame: 12 weeks
|
Follow-up completion
|
12 weeks
|
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The % of SMS queries with valid responses
Time Frame: 6 weeks
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Response rates to SMS queries
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6 weeks
|
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The % of participants who at least agree that the SMS program helped them reduce their drinking
Time Frame: 12 weeks
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A single question with response options: completely disagree to completely agree
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
# Binge drinking days
Time Frame: 6-weeks
|
Count of binge drinking days using TLFB 30-day calendar
|
6-weeks
|
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Binge drinking days
Time Frame: 12-weeks
|
Count of binge drinking days using TLFB 30-day calendar
|
12-weeks
|
|
Drinks per drinking day
Time Frame: 6-weeks
|
Mean drinks per drinking day using TLFB 30-day calendar
|
6-weeks
|
|
Drinks per drinking day
Time Frame: 12-weeks
|
Mean drinks per drinking day using TLFB 30-day calendar
|
12-weeks
|
|
# Alcohol negative consequences
Time Frame: 6-weeks
|
B-YAACQ: 24 yes/no questions
|
6-weeks
|
|
Alcohol negative consequences
Time Frame: 12-weeks
|
B-YAACQ: 24 yes/no questions
|
12-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian Suffoletto, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2023
Primary Completion (Actual)
January 1, 2024
Study Completion (Actual)
January 1, 2024
Study Registration Dates
First Submitted
April 28, 2023
First Submitted That Met QC Criteria
May 8, 2023
First Posted (Actual)
May 18, 2023
Study Record Updates
Last Update Posted (Estimated)
November 22, 2024
Last Update Submitted That Met QC Criteria
November 20, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 67584
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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