Ignite Creation Date:
2024-05-06 @ 5:44 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05414344
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2022-06-02
Brief Title:
A Brief Intervention for Alcohol Users With Interpersonal Trauma
Sponsor:
Western Kentucky University
Organization:
Western Kentucky University
Study Overview
Official Title:
A Randomized Controlled Trial of a Trauma-Informed and Peer-Supported Brief Intervention for Alcohol Users With Interpersonal Trauma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 eg 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 N55 Group 2 Mobile-delivered standard substance use BI N55 and Group 3 Assessment only N55
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 alcoholcannabis use alcoholcannabis 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
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 ie 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 eg 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 N55 Group 2 Mobile-delivered standard substance use BI N55 and Group 3 Assessment only N55
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 alcoholcannabis use alcoholcannabis 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None