Efficacy of a Smartphone-Based JITAI to Reduce Drinking Among Adults Experiencing Homelessness

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT06821295
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Alcohol Misuse
  • Homeless

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Smart-T Alcohol — OTHER
    The Smart-T Alcohol intervention offers on-demand content and automated contextually tailored messages to reduce alcohol consumption. The intervention period will span eight-weeks (i.e., weeks 2-9), with follow-up assessments occurring at weeks 9, 13, and 26. All participants will complete brief daily smartphone-based surveys for 13 weeks.
  • Usual Care — OTHER
    Participants will receive standard shelter-based treatment (Usual Care) along with completing surveys and assessments.

Study Details

Approximately 1 out of every 3 adults experiencing homelessness has a current alcohol use disorder (AUD). Alcohol use plays a central role in increased morbidity and mortality in this population, with some studies suggesting it plays a direct role in as many as 17% of deaths. Alcohol is also a leading cause of homelessness and contributes to its chronicity by inhibiting progress toward obtaining employment and a stable living environment. Shelter-based treatments are common, but compliance is often poor. There are many documented challenges to effectively implementing traditional evidence-based interventions in shelter settings. In the current project, we will conduct a randomized controlled trial. Adults currently experiencing homelessness who report hazardous alcohol use (N = 600) will be recruited from five shelters across the Dallas, TX and Oklahoma City, OK metropolitan areas. Individuals will attend screening and training visits, then complete one week of self-monitoring (via smartphone app) before being randomized to receive either standard shelter-based treatment (Usual Care; UC), or the Smart-T Alcohol intervention + UC. The Smart-T Alcohol intervention offers on-demand content and automated contextually tailored messages to reduce alcohol consumption. The intervention period will span eight-weeks (i.e., weeks 2-9), with follow-up assessments occurring at weeks 9, 13, and 26. All participants will complete brief daily smartphone-based surveys for 13 weeks. Aims of the project will be to assess the effects of the Smart-T Alcohol intervention on alcohol use and alcohol-related problems (Aim 1), intervention effects on key drinking risk indicators and their mediation of use outcomes (Aim 2), and identify specific subpopulations (e.g., women, racial/ethnic minorities, younger adults; Exploratory Aim 3) for which the intervention is most effective. Findings will provide a rigorous evaluation of the efficacy of the Smart-T Alcohol intervention and guide future smartphone-based interventions for this population.

Key Dates

Start date
Mar 5, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Usual Care (UC)
    All participants at the recruitment sites have access to 12-step support groups, intensive or supportive outpatient services, and/or medical and/or psychiatric care. All participants that report heavy drinking episode(s) during daily smartphone-based surveys will be referred for additional treatment services via a designated shelter referral/contact.
  • Experimental: Usual Care + Smart-T Alcohol
    The Smart-T Alcohol arm will receive Usual Care plus the Smart-T Alcohol smartphone-based intervention which includes two core components: 1) an on-demand "Tips" function/button; and 2) an algorithm that uses daily survey responses to assess current risk for alcohol use and automatically delivers tailored messages to help participants achieve their daily drinking goal.

Primary Outcome Measure

Number of drinks per week [ Time Frame: 13 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Michael S Businelle, PhD
[email protected]
405-271-8001
Krista Kezbers, PhD
[email protected]
405-271-8001

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By research site
University of Oklahoma Health Sciences Center· Oklahoma City, OK

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