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A Brief Intervention for Alcohol Users With Interpersonal Trauma

Primary Purpose

Heavy Drinking, Alcohol Drinking, Substance Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Brief Intervention
Trauma-Informed and Peer-Supported Brief Intervention
Assessment only
Sponsored by
Western Kentucky University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heavy Drinking focused on measuring Brief intervention, Cannabis, Trauma, Alcohol, Drinking, Peer coach

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 to 25
  2. Part-time or full-time college student
  3. Ability to speak and understand English
  4. Access to a cell phone
  5. Lifetime history of interpersonal trauma exposure
  6. Heavy alcohol use

Exclusion Criteria:

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

Sites / Locations

  • Western Kentucky UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Standard Brief Intervention

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

Assessment only

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Alcohol use
The Daily Drinking Questionnaire
Alcohol use
The Daily Drinking Questionnaire
Alcohol use
The Brief Young Adult Alcohol Consequences Questionnaire
Alcohol use
The Brief Young Adult Alcohol Consequences Questionnaire
Cannabis use
The Daily Sessions, Frequency, Age of Onset, Quantity of Cannabis Use Inventory (DFAQ-CU)
Cannabis use
The Daily Sessions, Frequency, Age of Onset, Quantity of Cannabis Use Inventory (DFAQ-CU)
Cannabis-related problems
The Marijuana Problems Scale; scores range from 0-38; higher scores reflect greater problems
Cannabis-related problems
The Marijuana Problems Scale; scores range from 0-38; higher scores reflect greater problems
Intervention Feasibility
Percentage of drop out in the interventions
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.
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.

Secondary Outcome Measures

Marijuana use motives
The Comprehensive Marijuana Motives Questionnaire; scores range from 3 to 15; higher scores reflect greater endorsement of motives
Marijuana use motives
The Comprehensive Marijuana Motives Questionnaire; scores range from 3 to 15; higher scores reflect greater endorsement of motives
Alcohol use motives
Modified Drinking Motives Questionnaire - Revised
Alcohol use motives
Modified Drinking Motives Questionnaire - Revised
Substance-related coping
The Brief Cope Inventory; scores range from 2 to 8; higher scores reflected greater use of the specified coping method
Substance-related coping
The Brief Cope Inventory; scores range from 2 to 8; higher scores reflected greater use of the specified coping method
Coping self-efficacy
The Coping Self-Efficacy Scale; scores range from 0-260; higher scores reflect greater coping self-efficacy
Coping self-efficacy
The Coping Self-Efficacy Scale; scores range from 0-260; higher scores reflect greater coping self-efficacy

Full Information

First Posted
June 2, 2022
Last Updated
January 3, 2023
Sponsor
Western Kentucky University
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1. Study Identification

Unique Protocol Identification Number
NCT05414344
Brief Title
A Brief Intervention for Alcohol Users With Interpersonal Trauma
Official Title
A Randomized Controlled Trial of a Trauma-Informed and Peer-Supported Brief Intervention for Alcohol Users With Interpersonal Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Kentucky University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Alcohol is the most frequently used substances in the United States, and emerging adults (EAs) ages 18-25 have the highest rates of heavy substance use of any age group. Heavy and persistent alcohol is linked with a host of negative outcomes in EAs, including poor mental health, lower life satisfaction, cognitive impairments, poor academic performance, increased risk for motor vehicle accidents, and substance use disorders. Brief interventions (BIs) for substance use typically consist of one to two individual sessions with personalized feedback about substance use. BIs aim to correct inaccurate normative beliefs and highlight personal consequences of substance use. BIs for alcohol use have demonstrated reductions in drinking and alcohol-related problems in numerous clinical trials. However, problems with BIs include 1) effect sizes are typically small and dissipate over time and 2) BIs for substance use demonstrate little to no effectiveness in individuals with interpersonal trauma (i.e., human-perpetrated violence) and interpersonal trauma-related distress. A potential reason for small or null effects of BIs for substance use in EAs are that existing interventions fail to tailor components to specific groups at high risk for substance issues, such as interpersonal trauma survivors. This limited effectiveness may be enhanced by 1) targeting coping motives, a consistent predictor of heavy and persistent alcohol use for interpersonal trauma survivors that is omitted from traditional BIs and 2) use of peer coaches to enhance outcomes following BI delivery. There are many reasons that greater focus on trauma, coping, and peer influence in BIs could improve outcomes among substance using EAs. Individuals are most likely to experience interpersonal trauma during emerging adulthood, which in turn has been linked to worse mental health, lower social support, and higher rates of alcohol and cannabis use and problems. Studies on alcohol and cannabis use motives suggest that coping with negative emotions are common reasons for substance use among EAs, particularly for EAs with interpersonal trauma, driving heavy use. However, the connections between negative emotions, trauma, substance use, and coping are not addressed in standard BIs. Furthermore, traditional BIs do not provide healthy coping strategies for managing trauma-related negative emotions, despite many empirically supported and adaptive coping strategies that have been identified. Additionally, peer influence has a strong effect on initiation and maintenance of alcohol and cannabis use in EAs, and inclusion of affiliated peers in in-person BIs has been found to enhance treatment efficacy. However, studies have yet to incorporate peers into follow-up of BIs for substance use, despite the demonstrated utility of peer coaches in health interventions for other outcomes (e.g., weight loss). Importantly, in-person, counselor-delivered BIs have been critiqued as being costly and impractical to implement in real-world settings, inhibiting widespread dissemination. Given that few EAs seek out substance prevention or treatment services, highly accessible, low-cost ways of delivering BIs to this population are needed. Mobile phones are now ubiquitous and represent a particularly advantageous way to provide BIs. Recent research indicates that mobile-delivered substance use interventions show promise in this age group, but given poor treatment engagement often exhibited in many digital health interventions, these approaches may benefit from inclusion of peer coaches following intervention delivery. The primary goal of the proposed study is to examine the feasibility and efficacy of a mobile-delivered, trauma-informed and peer-supported BI (TIPS-BI) in a sample of EAs with interpersonal trauma histories. The study will enhance and extend research on BIs by: (a) providing intervention content focused on understanding the connection between trauma and substance use and teaching emotion regulation coping skills and (b) incorporating trained peer coaches into text-message-based follow-up. We will conduct a 3-group randomized controlled trial with 165 EAs (ages 18-25; project 60% female) with interpersonal trauma and recent heavy alcohol use. Groups will include Group 1: Mobile-delivered, TIPS-BI with peer coach follow-up (N=55), Group 2: Mobile-delivered standard substance use BI (N=55), and Group 3: Assessment only (N=55) Aim 1: Examine the feasibility and acceptability of the TIPS-BI. The investigators hypothesize that TIPS-BI will exhibit relatively low levels of dropout (<10%) at follow-up and will be similar to dropout rates shown in the standard BI. The investigators also believe that the TIPS-BI will be perceived by participants as satisfactory, relevant, helpful, and a low burden. Aims 2 & 3: Evaluate the efficacy of the TIPS-BI in a randomized controlled trial. The investigators hypothesize that the TIPS-BI will be associated with greater reductions in alcohol/cannabis use, alcohol/cannabis problems, and coping motives at 3 and 6-month follow-ups relative to the standard BI and assessment only. The investigators also hypothesize that the TIPS-BI will result in greater increases in coping self-efficacy at 3 and 6-month follow-ups relative to the standard BI and assessment only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heavy Drinking, Alcohol Drinking, Substance Use, Drinking Behavior
Keywords
Brief intervention, Cannabis, Trauma, Alcohol, Drinking, Peer coach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Brief Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Trauma-Informed and Peer-Supported Brief Intervention (TIPS-BI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Assessment only
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Brief Intervention
Intervention Description
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
Intervention Name(s)
Trauma-Informed and Peer-Supported Brief Intervention
Intervention Description
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
Intervention Name(s)
Assessment only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alcohol use
Description
The Daily Drinking Questionnaire
Time Frame
Change from Baseline to 3 month follow-up
Title
Alcohol use
Description
The Daily Drinking Questionnaire
Time Frame
Change from Baseline to 6 month follow-up
Title
Alcohol use
Description
The Brief Young Adult Alcohol Consequences Questionnaire
Time Frame
Change from Baseline to 3 month follow-up
Title
Alcohol use
Description
The Brief Young Adult Alcohol Consequences Questionnaire
Time Frame
Change from Baseline to 6 month follow-up
Title
Cannabis use
Description
The Daily Sessions, Frequency, Age of Onset, Quantity of Cannabis Use Inventory (DFAQ-CU)
Time Frame
Change from baseline to 3-month follow-up
Title
Cannabis use
Description
The Daily Sessions, Frequency, Age of Onset, Quantity of Cannabis Use Inventory (DFAQ-CU)
Time Frame
Change from baseline to 6-month follow-up
Title
Cannabis-related problems
Description
The Marijuana Problems Scale; scores range from 0-38; higher scores reflect greater problems
Time Frame
Change from baseline to 3-month follow-up
Title
Cannabis-related problems
Description
The Marijuana Problems Scale; scores range from 0-38; higher scores reflect greater problems
Time Frame
Change from baseline to 6-month follow-up
Title
Intervention Feasibility
Description
Percentage of drop out in the interventions
Time Frame
6 month follow-up
Title
Intervention Acceptability
Description
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.
Time Frame
6 month follow-up
Title
Intervention Helpfulness
Description
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.
Time Frame
6 month follow-up
Secondary Outcome Measure Information:
Title
Marijuana use motives
Description
The Comprehensive Marijuana Motives Questionnaire; scores range from 3 to 15; higher scores reflect greater endorsement of motives
Time Frame
Change from baseline to 3-month follow-up
Title
Marijuana use motives
Description
The Comprehensive Marijuana Motives Questionnaire; scores range from 3 to 15; higher scores reflect greater endorsement of motives
Time Frame
Change from baseline to 6-month follow-up
Title
Alcohol use motives
Description
Modified Drinking Motives Questionnaire - Revised
Time Frame
Change from baseline to 3-month follow-up
Title
Alcohol use motives
Description
Modified Drinking Motives Questionnaire - Revised
Time Frame
Change from baseline to 6-month follow-up
Title
Substance-related coping
Description
The Brief Cope Inventory; scores range from 2 to 8; higher scores reflected greater use of the specified coping method
Time Frame
Change from baseline to 3-month follow-up
Title
Substance-related coping
Description
The Brief Cope Inventory; scores range from 2 to 8; higher scores reflected greater use of the specified coping method
Time Frame
Change from baseline to 6-month follow-up
Title
Coping self-efficacy
Description
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
Title
Coping self-efficacy
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 1) Currently receiving psychological therapy or psychotropic medication for substance use.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matt Woodward, Ph.D.
Phone
270-745-3919
Email
matthew.woodward@wku.edu
Facility Information:
Facility Name
Western Kentucky University
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matt Woodward, Ph.D.
Phone
254-723-3955
Email
matthew.woodward@wku.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11571067
Citation
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.
Results Reference
result
PubMed Identifier
9159696
Citation
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.
Results Reference
result
PubMed Identifier
30045752
Citation
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.
Results Reference
result
PubMed Identifier
31174710
Citation
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.
Results Reference
result
PubMed Identifier
30869917
Citation
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.
Results Reference
result

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A Brief Intervention for Alcohol Users With Interpersonal Trauma

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