NCT05864235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

May 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

April 28, 2023

Last Update Submit

November 20, 2024

Conditions

Keywords

young adultsbinge drinkingtext message

Outcome Measures

Primary Outcomes (4)

  • The % of people screened to participants enrolled

    Online recruitment efficiency

    2 months

  • The % of participants who complete both 6- and 12-week web-based assessments

    Follow-up completion

    12 weeks

  • The % of SMS queries with valid responses

    Response rates to SMS queries

    6 weeks

  • 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 Outcomes (6)

  • # Binge drinking days

    6-weeks

  • Binge drinking days

    12-weeks

  • Drinks per drinking day

    6-weeks

  • Drinks per drinking day

    12-weeks

  • # Alcohol negative consequences

    6-weeks

  • +1 more secondary outcomes

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Goal Support (GS)

EXPERIMENTAL

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: ControlBehavioral: Goal Support (GS)

GS + Coaching for Context-specific Peer Support (CCPS)

EXPERIMENTAL

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: ControlBehavioral: Goal Support (GS)Behavioral: Coaching for Context-specific Peer Support (CCPS)

Interventions

ControlBEHAVIORAL

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.

ControlGS + Coaching for Context-specific Peer Support (CCPS)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.

GS + Coaching for Context-specific Peer Support (CCPS)Goal Support (GS)

Each week for 6-weeks, CCPS group participants will receive weekly motivation and strategies to enlist peer support during drinking episodes.

GS + Coaching for Context-specific Peer Support (CCPS)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94301, United States

Location

MeSH Terms

Conditions

Alcohol DrinkingBinge Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Brian Suffoletto

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 18, 2023

Study Start

May 4, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

November 22, 2024

Record last verified: 2024-11

Locations