NCT07118826

Brief Summary

This proposal seeks to improve a mobile-based brief intervention for young adults who engage in heavy alcohol use and have experienced interpersonal trauma. The enhancement involves incorporating adaptive coping strategies to address trauma-related distress and engaging peer coaches following the intervention to support sustained treatment effects. Participants will be randomly assigned to receive either the enhanced intervention with peer coaching or a standard version of the brief intervention. Follow-up assessments will be conducted at 3 and 6 months after the intervention. The research team expects that the trauma-informed and peer-supported brief intervention (TIPS-BI) will have low dropout rates, be well-received by participants, and lead to greater reductions in alcohol use than the standard brief intervention.

Trial Health

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Trial Health Score

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

Timeline
17mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Progress33%
Sep 2025Oct 2027

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

August 5, 2025

Last Update Submit

February 24, 2026

Conditions

Keywords

Brief interventionAlcoholTraumaDrinkingPeer coaching

Outcome Measures

Primary Outcomes (7)

  • Alcohol use

    The Daily Drinking Questionnaire

    Change from Baseline to 3-month follow-up

  • Alcohol use

    The Daily Drinking Questionnaire

    Change from Baseline to 6-month follow-up

  • Alcohol consequences

    The Brief Young Adult Alcohol Consequences Questionnaire

    Change from Baseline to 3-month follow-up

  • Alcohol consequences

    The Brief Young Adult Alcohol Consequences Questionnaire

    Change from Baseline to 6-month follow-up

  • Intervention feasibility

    Percentage of drop out in the interventions

    6-month follow-up

  • Intervention acceptability

    Participants in both the standard and modified brief interventions will be asked to rate on a Likert scale how satisfied they were with the brief intervention content.

    Baseline

  • Peer coaching acceptability

    Participants in the modified brief intervention will be asked to rate on a Likert scale how satisfied they were with the peer coaching.

    Baseline

Secondary Outcomes (6)

  • Alcohol use motives

    Baseline to 3-month follow-up

  • Alcohol use motives

    Baseline to 6-month follow-up

  • Substance-related coping

    Baseline to 3-month follow-up

  • Substance-related coping

    Baseline to 6-month follow-up

  • Coping self-efficacy

    Change from baseline to 3-month follow-up

  • +1 more secondary outcomes

Study Arms (2)

Standard Brief Intervention

EXPERIMENTAL

Immediately following completion of the baseline assessment, participants will be texted a link to a secure website which contains the participant's personalized feedback. Personalized feedback is automatically presented via a programming algorithm that is based on the participants baseline survey responses. The personalized feedback component will include a personalized substance use profile, information on peer norms, prior substance-related consequences experienced by the participant, practical costs (e.g., money spent on substances, fees for a DUI), and standard protective behavioral strategies to limit substance-related risk.

Behavioral: Standard Brief InterventionBehavioral: Trauma-Informed and Peer-Supported Brief Intervention

Trauma-Informed and Peer-Supported Brief Intervention

EXPERIMENTAL

In addition to the components of the standard brief intervention, the TIPS-BI will include personalized feedback about participants use of substances to cope. Additionally, participants will be provided with psychoeducation about the link between substance use, trauma, and coping motives, and information highlighting the iatrogenic effects that substance use has on negative emotions. Participants will also be given a series of evidence-based alternative coping strategies for managing trauma-related distress such as anxiety, depression, and PTSD. Participants will be asked to set goals related to utilization of these alternative coping strategies. Participants will then be informed that a trained peer who is part of the research team will follow up with them via text message at the monthly time points to review adherence to their goals and offer support.

Behavioral: Trauma-Informed and Peer-Supported Brief Intervention

Interventions

In addition to the components of the standard brief intervention, the TIPS-BI will include personalized feedback about participants use of substances to cope. Additionally, participants will be provided with psychoeducation about the link between substance use, trauma, and coping motives, and information highlighting the iatrogenic effects that substance use has on negative emotions. Participants will also be given a series of evidence-based alternative coping strategies for managing trauma-related distress such as anxiety, depression, and PTSD. Participants will be asked to set goals related to utilization of these alternative coping strategies. Participants will then be informed that a trained peer who is part of the research team will follow up with them via text message at the monthly time points to review adherence to their goals and offer support.

Standard Brief InterventionTrauma-Informed and Peer-Supported Brief Intervention

Immediately following completion of the baseline assessment, participants will be texted a link to a secure website which contains the participant's personalized feedback. Personalized feedback is automatically presented via a programming algorithm that is based on the participants baseline survey responses. The personalized feedback component will include a personalized substance use profile, information on peer norms, prior substance-related consequences experienced by the participant, practical costs (e.g., money spent on substances, fees for a DUI), and standard protective behavioral strategies to limit substance-related risk.

Standard Brief Intervention

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 29
  • Ability to speak and understand English
  • Access to a cell phone
  • Lifetime history of interpersonal trauma exposure
  • Heavy alcohol use

You may not qualify if:

  • \) Currently receiving psychological therapy or psychotropic medication for substance use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Kentucky University

Bowling Green, Kentucky, 42101, United States

Location

Related Publications (6)

  • Bonomo Y, Coffey C, Wolfe R, Lynskey M, Bowes G, Patton G. Adverse outcomes of alcohol use in adolescents. Addiction. 2001 Oct;96(10):1485-96. doi: 10.1046/j.1360-0443.2001.9610148512.x.

    PMID: 11571067BACKGROUND
  • Wilk AI, Jensen NM, Havighurst TC. Meta-analysis of randomized control trials addressing brief interventions in heavy alcohol drinkers. J Gen Intern Med. 1997 May;12(5):274-83. doi: 10.1046/j.1525-1497.1997.012005274.x.

    PMID: 9159696BACKGROUND
  • Kurtz SP, Pagano ME, Buttram ME, Ungar M. Brief interventions for young adults who use drugs: The moderating effects of resilience and trauma. J Subst Abuse Treat. 2019 Jun;101:18-24. doi: 10.1016/j.jsat.2019.03.009. Epub 2019 Mar 24.

    PMID: 31174710BACKGROUND
  • Bountress KE, Cusack SE, Sheerin CM, Hawn S, Dick DM, Kendler KS, Amstadter AB. Alcohol consumption, interpersonal trauma, and drinking to cope with trauma-related distress: An auto-regressive, cross-lagged model. Psychol Addict Behav. 2019 May;33(3):221-231. doi: 10.1037/adb0000457. Epub 2019 Mar 14.

    PMID: 30869917BACKGROUND
  • Tanner-Smith EE, Parr NJ, Schweer-Collins M, Saitz R. Effects of brief substance use interventions delivered in general medical settings: a systematic review and meta-analysis. Addiction. 2022 Apr;117(4):877-889. doi: 10.1111/add.15674. Epub 2021 Oct 14.

    PMID: 34647649BACKGROUND
  • Teeters JB, Soltis KE, Murphy JG. A Mobile Phone-Based Brief Intervention With Personalized Feedback and Text Messaging Is Associated With Reductions in Driving After Drinking Among College Drinkers. J Stud Alcohol Drugs. 2018 Sep;79(5):710-719. doi: 10.15288/jsad.2018.79.710.

    PMID: 30422784BACKGROUND

MeSH Terms

Conditions

Alcohol DrinkingSubstance-Related DisordersDrinking BehaviorWounds and Injuries

Condition Hierarchy (Ancestors)

BehaviorChemically-Induced DisordersMental Disorders
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either 1) a standard brief intervention 2) a modified brief intervention with peer coaching and trauma-related information
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations