A Brief Intervention for Young Adult Substance Users With Interpersonal Trauma

NCT ID: NCT07118826

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heavy Drinking Alcohol Drinking Substance Use Drinking Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to either 1) a standard brief intervention 2) a modified brief intervention with peer coaching and trauma-related information
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Standard Brief Intervention

Intervention Type BEHAVIORAL

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.

Trauma-Informed and Peer-Supported Brief Intervention

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Trauma-Informed and Peer-Supported Brief Intervention

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

1\) Currently receiving psychological therapy or psychotropic medication for substance use.
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Western Kentucky University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Western Kentucky University

Bowling Green, Kentucky, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Matt Woodward, Ph.D.

Role: CONTACT

270-745-3919

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Matt Woodward, Ph.D.

Role: primary

270-745-3919

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 11571067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9159696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31174710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30869917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34647649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30422784 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1839376-8

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Alcohol Use and Relationships - III
NCT01753986 UNKNOWN PHASE2
BEing Safe in Treatment
NCT03575585 COMPLETED PHASE2
Multi-Component Breath Alcohol Intervention
NCT06124898 ACTIVE_NOT_RECRUITING NA