Back to resultsTexting to Reduce Alcohol Misuse Pilot Trial (TRAM)
Primary Purpose
Alcohol Consumption
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Goal Support (GS)
Coaching for Context-specific Peer Support (CCPS)
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Consumption focused on measuring young adults, binge drinking, text message
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control
Goal Support (GS)
GS + Coaching for Context-specific Peer Support (CCPS)
Arm Description
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 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, 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.
Outcomes
Primary Outcome Measures
The % of people screened to participants enrolled
Online recruitment efficiency
The % of participants who complete both 6- and 12-week web-based assessments
Follow-up completion
The % of SMS queries with valid responses
Response rates to SMS queries
The % of participants who at least agree that the SMS program helped them reduce their drinking
A single question with response options: completely disagree to completely agree
Secondary Outcome Measures
# Binge drinking days
Count of binge drinking days using TLFB 30-day calendar
Binge drinking days
Count of binge drinking days using TLFB 30-day calendar
Drinks per drinking day
Mean drinks per drinking day using TLFB 30-day calendar
Drinks per drinking day
Mean drinks per drinking day using TLFB 30-day calendar
# Alcohol negative consequences
B-YAACQ: 24 yes/no questions
Alcohol negative consequences
B-YAACQ: 24 yes/no questions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05864235
Brief Title
Texting to Reduce Alcohol Misuse Pilot Trial
Acronym
TRAM
Official Title
Texting to Reduce Alcohol Misuse Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
Keywords
young adults, binge drinking, text message
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Goal Support (GS)
Arm Type
Experimental
Arm Description
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.
Arm Title
GS + Coaching for Context-specific Peer Support (CCPS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Goal Support (GS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coaching for Context-specific Peer Support (CCPS)
Intervention Description
Each week for 6-weeks, CCPS group participants will receive weekly motivation and strategies to enlist peer support during drinking episodes.
Primary Outcome Measure Information:
Title
The % of people screened to participants enrolled
Description
Online recruitment efficiency
Time Frame
2 months
Title
The % of participants who complete both 6- and 12-week web-based assessments
Description
Follow-up completion
Time Frame
12 weeks
Title
The % of SMS queries with valid responses
Description
Response rates to SMS queries
Time Frame
6 weeks
Title
The % of participants who at least agree that the SMS program helped them reduce their drinking
Description
A single question with response options: completely disagree to completely agree
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
# Binge drinking days
Description
Count of binge drinking days using TLFB 30-day calendar
Time Frame
6-weeks
Title
Binge drinking days
Description
Count of binge drinking days using TLFB 30-day calendar
Time Frame
12-weeks
Title
Drinks per drinking day
Description
Mean drinks per drinking day using TLFB 30-day calendar
Time Frame
6-weeks
Title
Drinks per drinking day
Description
Mean drinks per drinking day using TLFB 30-day calendar
Time Frame
12-weeks
Title
# Alcohol negative consequences
Description
B-YAACQ: 24 yes/no questions
Time Frame
6-weeks
Title
Alcohol negative consequences
Description
B-YAACQ: 24 yes/no questions
Time Frame
12-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Suffoletto
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Texting to Reduce Alcohol Misuse Pilot Trial
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