Clinical trial NCT04302740: Life Enhancing Alcohol-management Program
Official title: A Cluster-randomized Controlled Trial Testing the Effectiveness of the Life Enhancing Alcohol-management Program (LEAP) for Housing First Residents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Use, Unspecified
Homelessness
Harm Reduction
Community Based Participatory Research
Keywords: Alcohol-Related Harm
Meaningful Activities
Quality of Life
Housing First
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Washington State University
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-03-10
Enrollment: 161
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 Housing First sites will be optimally matched and block randomized on a rolling basis to either LEAP or services-as-usual control conditions.
Primary purpose: SUPPORTIVE_CARE

Brief summary: People experiencing chronic homelessness comprise a small yet high-morbidity, high-cost subset of the larger homeless population and are disproportionately impacted by alcohol-related harm. Unfortunately, traditional abstinence-based treatment does not adequately reach or engage this population, and both firsthand (problems stemming from one's own alcohol use) and secondhand (problems stemming from others' alcohol use) alcohol-related harm persists even after housing attainment. There have therefore been calls for more flexible and client-centered approaches tailored to this population's needs. Housing First, which entails the provision of immediate, permanent, low-barrier, nonabstinence-based housing, is a response to this call. Research has shown that Housing First is associated with decreased alcohol use, alcohol-related harm, and publicly funded service utilization. Nonetheless, Housing First residents continue to experience both first- and secondhand alcohol-related harm. Thus, further community-based interventions are necessary. To this end, a pilot project was conducted in which researchers as well as Housing First residents, staff and management codeveloped, implemented, and initially evaluated the Life Enhancing Alcohol-management Program (LEAP). The LEAP entails low-barrier, community-level, house-wide resident programming-including leadership opportunities, activities, and pathways to recovery. At the 6-month follow up, LEAP participants reported significantly more engagement in meaningful activities than control participants (p \< .001). Moreover, high levels of LEAP program engagement (\>2 activities per month) predicted significant reductions in alcohol use and alcohol-related harm (ps \< .01). To build on these promising findings, we propose a larger, cluster-randomized controlled trial of LEAP (N=160) as an innovative, community-based, and client-driven adjunct to Housing First. Analyses will test LEAP effectiveness in increasing engagement in meaningful activities, decreasing alcohol use, ameliorating both first- and secondhand alcohol-related harm, and improving quality of life. Engagement in meaningful activities will also be tested as a mediator of the LEAP effect on alcohol and quality-of-life outcomes. Finally, we will assess whether LEAP is associated with reduced costs stemming from participants' use of emergency health-care and criminal justice services.

Detailed description: Although they represent only 15% of the larger homeless population, chronically homeless people utilize substantially more services. This finding is understandable given that chronic homelessness is characterized by long or frequent episodes of homelessness paired with medical, psychiatric, and substance use disorders. Although epidemiologic data for chronically homeless people are scarce, studies conducted with the larger homeless population indicate that 80% of homeless people report current alcohol use, and 38% have severe alcohol use disorders (AUDs). This disproportionately problematic use results in alcohol-attributable mortality that is 6 to 10 times higher than in the general US population. Alcohol-related harm impacts the affected individual; however, it also has secondhand effects on the larger community as well, including caretaking burden, noise complaints, verbal altercations, and physical and sexual assault.

Unfortunately, the most widely available approach-individual-level, abstinence-based treatment-does not effectively engage or treat this population. In our prior research, chronically homeless people with AUDs indicated they were not interested in abstinence-based approaches, having experienced a mean of 16 abstinence-based treatment episodes in their lifetimes. Further, our research has shown that improvements in alcohol outcomes in this population are associated with intrinsic motivation for change but not with abstinence-based treatment attendance. Instead, chronically homeless people with AUDs have indicated that they prefer community-based, harm-reduction approaches that support their own self-defined pathways to recovery. They are particularly interested in creative and socially engaging activities that bear personal meaning.

As applied to alcohol use, harm reduction refers to a broad range of compassionate and pragmatic approaches applied at the individual, community, population or policy levels that aim to reduce alcohol-related harm and improve quality of life (QoL) for affected people and their communities. Housing First, also referred to as harm-reduction housing, is one such approach. Housing First entails the provision of immediate, permanent, low-barrier, supportive housing without preconditions such as alcohol abstinence or treatment attendance. Our own and others' research has shown Housing First to be associated with reductions in alcohol-related harm as well as publicly funded service utilization and cost (e.g., emergency medical services, emergency department, jail) for people experiencing chronic homelessness. Despite these positive outcomes, many Housing First residents still experience alcohol-related harm due to their own and their neighbors' alcohol use. There is thus a need for further interventions to address alcohol use in this setting.

In response to this need, our research team used a community-based participatory research approach to work together with Housing First residents, management and staff to develop and initially test the effectiveness of a community-level intervention, the Life Enhancing Alcohol-management Program (LEAP) to improve alcohol and quality-of-life (QoL) outcomes for residents living in Housing First settings (K01AA021147; PI: Clifasefi). We first conducted needs assessments with residents, staff, and management and then formed a community advisory board to oversee the development, implementation, and evaluation of the LEAP. Together, we developed LEAP values, processes, and components. LEAP components for residents included leadership opportunities, LEAP activities, and pathways to recovery. Once developed, the LEAP was tested in a nonrandomized controlled pilot (N=116) with residents at 3 Housing First sites: 2 sites served as services-as-usual control sites and 1 received LEAP. Findings were promising: LEAP participants reported significantly more engagement in meaningful activities than control participants. This finding is important because engagement in meaningful activities is associated with improved medical, psychiatric, and substance-use outcomes. In within-subjects analyses, LEAP participants showed significant pre-post reductions in alcohol use and alcohol-related problems. These changes showed a dose-response effect based on participants' attendance at LEAP activities: high levels of LEAP programming engagement (\>2 activities per month) predicted significant reductions in alcohol quantity and alcohol-related harm (ps \< .01).

To establish a more definitive evidence base for LEAP, we propose to test LEAP effectiveness using a 2-arm, 12-month, cluster-randomized controlled trial at 10 Housing First sites (N=160). Sites will be randomized to the services-as-usual control or LEAP conditions. Quantitative analyses will test LEAP effectiveness in improving participants' alcohol and QoL outcomes from baseline through the 3, 6-, and 12-month follow-up assessments.

The specific aims are to test:

1. LEAP effectiveness in reducing alcohol use and alcohol-related harm and improving QoL. Compared to controls, LEAP participants will report less alcohol use; less first- and secondhand alcohol-related harm; and improved health-related and general QoL over the follow-up.
2. Group differences in participants' engagement in meaningful activities as well as its role as a mediator of changes on alcohol and QoL outcomes.

   1. Over time, it is expected that LEAP participants will report more engagement in meaningful activities than control participants.
   2. It is expected that greater engagement in meaningful activities will explain the hypothesized positive LEAP effect on outcomes.
3. LEAP effects on costs associated with healthcare and criminal justice service utilization (i.e., emergency medical services, emergency department services, jail). Compared to control participants, LEAP participants will show greater decreases in service utilization costs over time.

Eligibility criteria: Inclusion Criteria:

* At-risk drinking as established by the AUDIT-C at screening (cut-off scores: men \> = 3, women \> = 2
* Having a history of chronic homelessness according to the widely accepted federal definition (i.e., having a psychiatric, medical, or substance use disorder paired with being homeless for a year or more or having 4 or more episodes of homelessness in the past 3 years)
* Being a current DESC client living in 1 of 10 participating Housing First sites

Exclusion Criteria:

* Refusal or inability to consent to participation in research
* Constituting a risk to the safety and security of other clients or staff

Primary outcomes:
measure: Alcohol and Substance-use Frequency Assessment
timeFrame: Change across the 12 month follow up
measure: The Alcohol Quantity and Use Assessment (AQUA)
timeFrame: Change across the 12-month follow-up
measure: Firsthand Alcohol-Related Harms
timeFrame: Change across the 12-month follow-up
measure: Secondhand Alcohol-Related Harms
timeFrame: Change across the 12-month follow-up
measure: EtG Presence
timeFrame: Change across the 12-month follow-up
measure: Costs associated with healthcare and criminal justice service utilization
timeFrame: 6 months prior to baseline through 12-month follow-up
Secondary outcomes:
measure: Health-Related Quality of Life
timeFrame: Change across the 12-month follow-up
measure: General Quality of Life
timeFrame: Change across the 12-month follow-up
measure: Attendance at Other Treatment and Mutual-Help Groups
timeFrame: Change across the 12-month follow-up
Other outcomes:
measure: Meaningful Activities Participation
timeFrame: Change across the 12-month follow-up
measure: Site-Specific Activity Participation
timeFrame: Change across the 12-month follow-up
measure: Adult Resilience Measure-Revised (ARM-R)
timeFrame: Change across the 12-month follow-up
Locations:
city: Seattle
country: United States
facility: University of Washington - Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Seema L Clifasefi, PhD MSW
role: PRINCIPAL_INVESTIGATOR
References: