ClinicalTrials.gg
WithdrawnNCT07118826Updated Feb 27, 2026

A Brief Intervention for Young Adult Substance Users With Interpersonal Trauma

An interventional study of Standard Brief Intervention and Trauma-Informed and Peer-Supported Brief Intervention in Heavy Drinking, Alcohol Drinking and Substance Use, sponsored by Western Kentucky University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Primary conditionAlcohol Drinking(the registry's first term)UnverifiedIs this wrong?Alcohol Drinking is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Western Kentucky University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Accidental duplicate entry into clinicaltrials.gov
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 29 Years
Sex
All
01

Study 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.

Read the detailed description

Alcohol is the most commonly used substance in the United States, with emerging adults (EAs) showing the highest rates of heavy use among all age groups. Persistent heavy drinking in this population is linked to a range of negative outcomes, including poor mental health, reduced life satisfaction, cognitive impairments, academic difficulties, increased risk for motor vehicle accidents, and the development of substance use disorders.

Brief interventions (BIs) for substance use typically involve one or two individual sessions that provide personalized feedback. These interventions aim to challenge inaccurate normative beliefs and emphasize personal consequences of substance use. While BIs have demonstrated success in reducing alcohol consumption and related problems in numerous clinical trials, their impact is often limited. Common challenges include small effect sizes that diminish over time and reduced effectiveness among individuals with interpersonal trauma-specifically, trauma involving human-perpetrated violence and associated emotional distress.

One explanation for these limited outcomes is that BIs are not tailored to high-risk groups such as trauma survivors. Improving BIs may require addressing two key gaps: (1) targeting coping motives-strong predictors of heavy and persistent drinking among trauma-exposed individuals that are typically not addressed in standard BIs, and (2) incorporating peer coaches to support continued gains after the intervention.

There are compelling reasons to integrate trauma content, coping strategies, and peer support into BIs for substance-using EAs. Emerging adulthood is the developmental stage with the highest risk of experiencing interpersonal trauma, which is linked to poor mental health, low social support, and elevated alcohol use. Research indicates that coping with negative emotions is a common motive for substance use in this age group-especially among trauma-exposed individuals-yet these connections are not typically addressed in standard BIs. Additionally, traditional BIs often fail to provide adaptive strategies for managing trauma-related emotional distress, despite the availability of evidence-based coping techniques.

Peer influence also plays a critical role in both initiating and maintaining substance use during emerging adulthood. Including affiliated peers in in-person BIs has improved treatment outcomes in past studies. However, few interventions have extended peer involvement to the post-intervention period, despite the demonstrated success of peer coaches in other health domains.

Further, in-person, counselor-delivered BIs have been criticized as costly and difficult to implement broadly, limiting their scalability. Since few EAs actively seek substance use prevention or treatment services, there is a pressing need for low-cost, accessible delivery methods. Given the widespread use of mobile phones, mobile-delivered BIs represent a promising approach. Early evidence suggests they can be effective with EAs, though engagement tends to be low. Incorporating peer coaches into follow-up may help address this issue and boost engagement.

The primary aim of the proposed study is to evaluate the feasibility and efficacy of a mobile-delivered, trauma-informed, and peer-supported brief intervention (TIPS-BI) for emerging adults with a history of interpersonal trauma. This study will advance the BI literature by:

  1. including content that links trauma to substance use and teaches emotion regulation strategies, and
  2. integrating trained peer coaches into the text-message follow-up phase.

A total of 190 emerging adults (ages 18-29, with 60% expected to be female) who have a history of interpersonal trauma and report recent heavy alcohol use will be enrolled in a two-arm randomized controlled trial. Participants will be assigned to one of two conditions:

Group 1: Mobile-delivered TIPS-BI with peer coach follow-up (N=95)

Group 2: Mobile-delivered standard substance use BI (N=95)

Aim 1: Assess the feasibility and acceptability of the TIPS-BI. The investigators hypothesize that the TIPS-BI will result in low dropout rates (\<10%) at follow-up, comparable to the standard BI. They also expect participants to rate the TIPS-BI as satisfactory, relevant, helpful, and minimally burdensome.

Aims 2 \& 3: Evaluate the efficacy of the TIPS-BI. It is hypothesized that participants in the TIPS-BI group will show greater reductions in alcohol use and coping motives at 3- and 6-month follow-ups compared to those receiving the standard BI. Additionally, the TIPS-BI is expected to lead to greater improvements in coping self-efficacy at both follow-up time points.

02

Conditions studied

  • Heavy Drinking
  • Alcohol Drinking
  • Substance Use
  • Drinking Behavior

Keywords

  • Brief intervention
  • Alcohol
  • Trauma
  • Drinking
  • Peer coaching
03

In context

Alcohol Drinking Unverified

701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.

Browse Alcohol Drinking studies →

Lead sponsor

Western Kentucky University is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 to 29
  2. Ability to speak and understand English
  3. Access to a cell phone
  4. Lifetime history of interpersonal trauma exposure
  5. Heavy alcohol use

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Standard 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.

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

  • Experimental
    Trauma-Informed and Peer-Supported Brief Intervention

    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

  • BehavioralStandard 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.

  • BehavioralTrauma-Informed and Peer-Supported Brief Intervention

    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.

06

What researchers measure

Primary outcomes

  1. Alcohol use

    The Daily Drinking Questionnaire

    Time frame: Change from Baseline to 3-month follow-up

  2. Alcohol use

    The Daily Drinking Questionnaire

    Time frame: Change from Baseline to 6-month follow-up

  3. Alcohol consequences

    The Brief Young Adult Alcohol Consequences Questionnaire

    Time frame: Change from Baseline to 3-month follow-up

  4. Alcohol consequences

    The Brief Young Adult Alcohol Consequences Questionnaire

    Time frame: Change from Baseline to 6-month follow-up

  5. Intervention feasibility

    Percentage of drop out in the interventions

    Time frame: 6-month follow-up

  6. 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.

    Time frame: Baseline

  7. 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.

    Time frame: Baseline

Secondary outcomes

  1. Alcohol use motives

    Modified Drinking Motives Questionnaire - Revised

    Time frame: Baseline to 3-month follow-up

  2. Alcohol use motives

    Modified Drinking Motives Questionnaire - Revised

    Time frame: Baseline to 6-month follow-up

  3. Substance-related coping

    The Brief Cope Inventory; scores range from 2 to 8; higher scores reflected greater use of the specified coping method

    Time frame: Baseline to 3-month follow-up

  4. Substance-related coping

    The Brief Cope Inventory; scores range from 2 to 8; higher scores reflected greater use of the specified coping method

    Time frame: Baseline to 6-month follow-up

  5. Coping self-efficacy

    The Coping Self-Efficacy Scale; scores range from 0-260; higher scores reflect greater coping self-efficacy.

    Time frame: Change from baseline to 3-month follow-up

  6. Coping self-efficacy

    The Coping Self-Efficacy Scale; scores range from 0-260; higher scores reflect greater coping self-efficacy.

    Time frame: Change from baseline to 6-month follow-up

07

Study locations

1 site
  • Western Kentucky University
    Bowling Green, Kentucky 42101, United States
08

References and documents

Publications

  • 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. PubMed 11571067 ↗
  • 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. PubMed 9159696 ↗
  • 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. PubMed 31174710 ↗
  • 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. PubMed 30869917 ↗
  • 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. PubMed 34647649 ↗
  • 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. PubMed 30422784 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07118826
Lead sponsor
Western Kentucky University
Responsible party
Sponsor
First posted
Aug 12, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Feb 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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