Texting to Reduce Alcohol Misuse Pilot Trial

Alcohol Consumption Clinical Trial

— TRAM  

Official title:

Texting to Reduce Alcohol Misuse Pilot Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05864235
• Other study ID #: 67584
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: May 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking

Intervention

Behavioral:
• 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.
• Goal Support (GS)
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.
• Coaching for Context-specific Peer Support (CCPS)
Each week for 6-weeks, CCPS group participants will receive weekly motivation and strategies to enlist peer support during drinking episodes.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The % of people screened to participants enrolled	Online recruitment efficiency	2 months
Primary	The % of participants who complete both 6- and 12-week web-based assessments	Follow-up completion	12 weeks
Primary	The % of SMS queries with valid responses	Response rates to SMS queries	6 weeks
Primary	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	12 weeks
Secondary	# Binge drinking days	Count of binge drinking days using TLFB 30-day calendar	6-weeks
Secondary	Binge drinking days	Count of binge drinking days using TLFB 30-day calendar	12-weeks
Secondary	Drinks per drinking day	Mean drinks per drinking day using TLFB 30-day calendar	6-weeks
Secondary	Drinks per drinking day	Mean drinks per drinking day using TLFB 30-day calendar	12-weeks
Secondary	# Alcohol negative consequences	B-YAACQ: 24 yes/no questions	6-weeks
Secondary	Alcohol negative consequences	B-YAACQ: 24 yes/no questions	12-weeks