NCT05414344

Brief Summary

The current proposal aims to enhance a mobile-delivered brief intervention for young adults with heavy alcohol use and interpersonal trauma by including adaptive coping strategies for managing trauma-related distress and using peer coaches after delivery of the intervention to maintain treatment gains. Individuals will be randomized to a modified brief intervention incorporating with peer coaches, a standard brief intervention, or assessment only. Participants will be followed up at 3 and 6 months post intervention. The investigators hypothesize that the trauma-informed and peer-supported brief intervention (TIPS-BI) will show low levels of dropout, will be perceived positively by participants, and will result in greater reductions in alcohol use compared to a standard brief intervention and assessment only.

Trial Health

55
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

June 2, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 29, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.6 years

First QC Date

June 2, 2022

Last Update Submit

February 23, 2026

Conditions

Heavy DrinkingAlcohol DrinkingSubstance UseDrinking Behavior

Keywords

Brief interventionCannabisTraumaAlcoholDrinkingPeer coach

Outcome Measures

Primary Outcomes (11)

  • 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 use

    The Brief Young Adult Alcohol Consequences Questionnaire

    Change from Baseline to 3 month follow-up

  • Alcohol use

    The Brief Young Adult Alcohol Consequences Questionnaire

    Change from Baseline to 6 month follow-up

  • Cannabis use

    The Daily Sessions, Frequency, Age of Onset, Quantity of Cannabis Use Inventory (DFAQ-CU)

    Change from baseline to 3-month follow-up

  • Cannabis use

    The Daily Sessions, Frequency, Age of Onset, Quantity of Cannabis Use Inventory (DFAQ-CU)

    Change from baseline to 6-month follow-up

  • Cannabis-related problems

    The Marijuana Problems Scale; scores range from 0-38; higher scores reflect greater problems

    Change from baseline to 3-month follow-up

  • Cannabis-related problems

    The Marijuana Problems Scale; scores range from 0-38; higher scores reflect greater problems

    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 intervention.

    6 month follow-up

  • Intervention Helpfulness

    Participants in both the standard and modified brief interventions will be asked to rate on a Likert scale how how helpful they found the intervention.

    6 month follow-up

Secondary Outcomes (8)

  • Marijuana use motives

    Change from baseline to 3-month follow-up

  • Marijuana use motives

    Change from baseline to 6-month follow-up

  • Alcohol use motives

    Change from baseline to 3-month follow-up

  • Alcohol use motives

    Change from baseline to 6-month follow-up

  • Substance-related coping

    Change from baseline to 3-month follow-up

  • +3 more secondary outcomes

Study Arms (3)

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 Intervention

Trauma-Informed and Peer-Supported Brief Intervention (TIPS-BI)

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

Assessment only

EXPERIMENTAL

Following the baseline survey, participants in the assessment only group will be texted again 3 and 6 months later to complete follow up assessments. Following the end of the 6-month follow-up, participants will be offered an opportunity to complete the TIPS-BI without peer coach follow-up.

Behavioral: Assessment only

Interventions

Standard Brief InterventionBEHAVIORAL

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
Trauma-Informed and Peer-Supported Brief InterventionBEHAVIORAL

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 (TIPS-BI)
Assessment onlyBEHAVIORAL

Following the baseline survey, participants in the assessment only group will be texted again 3 and 6 months later to complete follow up assessments. Following the end of the 6-month follow-up, participants will be offered an opportunity to complete the TIPS-BI without peer coach follow-up.

Assessment only

Eligibility Criteria

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

You may qualify if:

  • Age 18 to 25
  • Part-time or full-time college student
  • 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 (5)

  • 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

  • Halladay J, Petker T, Fein A, Munn C, MacKillop J. Brief interventions for cannabis use in emerging adults: protocol for a systematic review, meta-analysis, and evidence map. Syst Rev. 2018 Jul 25;7(1):106. doi: 10.1186/s13643-018-0772-z.

    PMID: 30045752BACKGROUND

  • 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

MeSH Terms

Conditions

Alcohol DrinkingSubstance-Related DisordersDrinking BehaviorMarijuana AbuseWounds and Injuries

Condition Hierarchy (Ancestors)

BehaviorChemically-Induced DisordersMental Disorders

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 or 3) assessment only
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 10, 2022

Study Start

September 29, 2022

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)