A Brief Intervention for Alcohol and Cannabis Users With Interpersonal Trauma

Sponsor

Western Kentucky University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05414344

Collaborator

(none)

165

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The current proposal aims to enhance a mobile-delivered brief intervention for young adults with heavy alcohol or cannabis 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 and cannabis use compared to a standard brief intervention and assessment only.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Alcohol Drinking Substance Use Drinking Behavior	Behavioral: Standard Brief Intervention Behavioral: Trauma-Informed and Peer-Supported Brief Intervention Behavioral: Assessment only	N/A

Detailed Description

Alcohol and cannabis are the two 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 and cannabis use are 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, 2) BIs targeting cannabis use do not consistently lead to decreases in cannabis use frequency or cannabis-related problems, and 3) 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 alcohol and cannabis 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 and cannabis 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 and/or cannabis 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

165 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 onlyParticipants 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)

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Trial of a Trauma-Informed and Peer-Supported Brief Intervention for Alcohol and Cannabis Users With Interpersonal Trauma

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 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.
Experimental: Trauma-Informed and Peer-Supported Brief Intervention (TIPS-BI) 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 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.
Experimental: Assessment only 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 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.

Arm

Intervention/Treatment

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

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

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

Experimental: Assessment only

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

Outcome Measures

Primary Outcome Measures

Alcohol use [Change from Baseline to 3 month follow-up]
The Daily Drinking Questionnaire
Alcohol use [Change from Baseline to 6 month follow-up]
The Daily Drinking Questionnaire
Alcohol use [Change from Baseline to 3 month follow-up]
The Brief Young Adult Alcohol Consequences Questionnaire
Alcohol use [Change from Baseline to 6 month follow-up]
The Brief Young Adult Alcohol Consequences Questionnaire
Cannabis use [Change from baseline to 3-month follow-up]
The Daily Sessions, Frequency, Age of Onset, Quantity of Cannabis Use Inventory
Cannabis use [Change from baseline to 6-month follow-up]
The Daily Sessions, Frequency, Age of Onset, Quantity of Cannabis Use Inventory
Cannabis-related problems [Change from baseline to 3-month follow-up]
The Marijuana Problems Scale
Cannabis-related problems [Change from baseline to 6-month follow-up]
The Marijuana Problems Scale
Intervention Feasibility [6 month follow-up]
Percentage of drop out in the interventions
Intervention Acceptability [6 month follow-up]
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 [6 month follow-up]
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

Substance use motives [Change from baseline to 3-month follow-up]
The Comprehensive Marijuana Motives Questionnaire
Substance use motives [Change from baseline to 6-month follow-up]
The Comprehensive Marijuana Motives Questionnaire
Substance use motives [Change from baseline to 3-month follow-up]
The Substance Use Motives Measure
Substance use motives [Change from baseline to 6-month follow-up]
The Substance Use Motives Measure
Substance-related coping [Change from baseline to 3-month follow-up]
The Brief Cope Inventory
Substance-related coping [Change from baseline to 6-month follow-up]
The Brief Cope Inventory
Coping self-efficacy [Change from baseline to 3-month follow-up]
The Coping Self-Efficacy Scale
Coping self-efficacy [Change from baseline to 6-month follow-up]
The Coping Self-Efficacy Scale