TRAM: Texting to Reduce Alcohol Misuse Pilot Trial

Sponsor
Stanford University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05864235
Collaborator
(none)
90
1
3
11.9
7.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Control
  • Behavioral: Goal Support (GS)
  • Behavioral: Coaching for Context-specific Peer Support (CCPS)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Texting to Reduce Alcohol Misuse Pilot Trial
Actual Study Start Date :
May 4, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

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.

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.

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.

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.

Behavioral: 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.

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.

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.

Behavioral: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. The % of people screened to participants enrolled [2 months]

    Online recruitment efficiency

  2. The % of participants who complete both 6- and 12-week web-based assessments [12 weeks]

    Follow-up completion

  3. The % of SMS queries with valid responses [6 weeks]

    Response rates to SMS queries

  4. The % of participants who at least agree that the SMS program helped them reduce their drinking [12 weeks]

    A single question with response options: completely disagree to completely agree

Secondary Outcome Measures

  1. # Binge drinking days [6-weeks]

    Count of binge drinking days using TLFB 30-day calendar

  2. Binge drinking days [12-weeks]

    Count of binge drinking days using TLFB 30-day calendar

  3. Drinks per drinking day [6-weeks]

    Mean drinks per drinking day using TLFB 30-day calendar

  4. Drinks per drinking day [12-weeks]

    Mean drinks per drinking day using TLFB 30-day calendar

  5. # Alcohol negative consequences [6-weeks]

    B-YAACQ: 24 yes/no questions

  6. Alcohol negative consequences [12-weeks]

    B-YAACQ: 24 yes/no questions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Palo Alto California United States 94301

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Brian Suffoletto, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brian Suffoletto, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier:
NCT05864235
Other Study ID Numbers:
  • 67584
First Posted:
May 18, 2023
Last Update Posted:
May 18, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Brian Suffoletto, Associate Professor of Medicine, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2023