Life Enhancing Alcohol-management Program

NCT04302740 | Completed DMC

• 2 other identifiers: STUDY000070481R01AA026593-01A1
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use, Unspecified; Homelessness; Harm Reduction; Community Based Participatory Research

Keywords

Alcohol-Related Harm; Meaningful Activities; Quality of Life; Housing First

Outcome Measures

Primary Outcomes (6)

• Alcohol and Substance-use Frequency Assessment

  The Alcohol and Substance-use Frequency Assessment questions were adapted from the Addiction Severity Index (McLellan, Kushner, Metzger, \& Peters, 1992) and will be used to assess frequency of use of alcohol and other substance use

  Change across the 12 month follow up

• The Alcohol Quantity and Use Assessment (AQUA)

  The Alcohol Quantity and Use Assessment (AQUA) was created by the research team for previous studies with a similar population and will be used to record the quantity of alcohol consumed on participants' heaviest, typical, and lightest drinking days in the past month. Scores are expressed in number of standard drinks with higher numbers indicating heavier drinking.

  Change across the 12-month follow-up

• Firsthand Alcohol-Related Harms

  The Short Inventory of Problems (SIP-2R) is a psychometrically reliable and valid, 15-item, Likert-scale questionnaire that measures experience with social, occupational, and psychological harms related to one's own alcohol use. Scores range from 0 to 45 with higher scores indicating more severe alcohol-related harm.

  Change across the 12-month follow-up

• Secondhand Alcohol-Related Harms

  Secondhand effects of alcohol will be measured using a newly developed, psychometrically sound questionnaire, augmented by items from prior validated surveys. The 8, dichotomous items include feeling unsafe; being harassed, bothered, called names or insulted; being pushed, hit or assaulted; having one's living space disturbed; having one's property stolen or damaged; experiencing unwanted sexual advances; having to take care of another resident who drank too much; and having sleep or other activities interrupted. The summary score will be used to reflect overall experience of secondhand alcohol-related harm as an outcome variable. Scores range from 0 to 30 with higher scores indicating more severe secondhand alcohol-related harm.

  Change across the 12-month follow-up

• EtG Presence

  Presence of EtG, a direct metabolite of alcohol (cut-off \> 500 ng/ml), which is indicative of heavy alcohol use within the past 3 days, will be used as a primary outcome.

  Change across the 12-month follow-up

• Costs associated with healthcare and criminal justice service utilization

  We will collect administrative data from local county and state databases reflecting participants' utilization of emergency medical services, hospital, and jail and associated cost estimates. These data will be summed across types to create overall cost outcomes, which will serve as the primary outcome for specific aim 3.

  6 months prior to baseline through 12-month follow-up

Secondary Outcomes (3)

• Health-Related Quality of Life

  Change across the 12-month follow-up

• General Quality of Life

  Change across the 12-month follow-up

• Attendance at Other Treatment and Mutual-Help Groups

  Change across the 12-month follow-up

Other Outcomes (3)

• Meaningful Activities Participation

  Change across the 12-month follow-up

• Site-Specific Activity Participation

  Change across the 12-month follow-up

• Adult Resilience Measure-Revised (ARM-R)

  Change across the 12-month follow-up

Study Arms (2)

LEAP

ACTIVE COMPARATOR

Housing First plus LEAP

Behavioral: LEAP

Service-As-Usual

NO INTERVENTION

Housing First

Interventions

LEAP BEHAVIORAL

The LEAP is a comprehensive, multidimensional, community-level intervention offered in Housing First settings that was developed using a CBPR framework. The LEAP principles, process, and components were conceptualized and operationalized by the CAB in the pilot study, and are outlined in a recently published articles in the American Psychologist and Journal of Community Psychology. Briefly, LEAP principles include recognizing and respecting community as a key unit of identity versus solely as individuals in a traditional research hierarchy; embracing cultural humility; practicing pragmatism and compassion; aiming to build equitable research partnerships with communities; acknowledging and promoting community strengths; and supporting relevant, sustainable, positive and community-led change.

LEAP

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• Washington State University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Washington - Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Harm Reduction

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Seema L Clifasefi, PhD MSW

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine: Psychiatry

Model Details: 10 Housing First sites will be optimally matched and block randomized on a rolling basis to either LEAP or services-as-usual control conditions.

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 10, 2020
• Study Start: February 21, 2020
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)