Completed

LEAPA Cluster-randomized Controlled Trial Testing the Effectiveness of the Life Enhancing Alcohol-management Program (LEAP) for Housing First Residents

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What is being tested

LEAP

Behavioral
Who is being recruted

Alcohol Drinking+1

+ Behavior

+ Drinking Behavior

Over 21 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: February 2020
See protocol details

Summary

Principal SponsorUniversity of Washington
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 21, 2020

Actual date on which the first participant was enrolled.

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.

Official TitleA Cluster-randomized Controlled Trial Testing the Effectiveness of the Life Enhancing Alcohol-management Program (LEAP) for Housing First Residents
NCT04302740
Principal SponsorUniversity of Washington
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

161 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alcohol DrinkingBehaviorDrinking BehaviorHarm Reduction

Criteria

3 inclusion criteria required to participate
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

2 exclusion criteria prevent from participating
Refusal or inability to consent to participation in research

Constituting a risk to the safety and security of other clients or staff

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Housing First plus LEAP

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Washington - Harborview Medical Center

Seattle, United StatesOpen University of Washington - Harborview Medical Center in Google Maps
CompletedOne Study Center