Efficacy of a Smartphone-Based JITAI to Reduce Drinking Among Adults Experiencing Homelessness
SmartT_A
2 other identifiers
interventional
600
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2025
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Start
First participant enrolled
March 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
May 1, 2026
April 1, 2026
4.2 years
February 6, 2025
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of drinks per week
The number of drinks per week reported during daily EMAs.
13 weeks
Number of heavy drinking days
Number of heavy drinking days reported in daily EMAs (defined in alignment with NIAAA guidelines as ≥ 5 drinks/day for men and ≥ 4 drinks/day for women).
13 weeks
Total number of drinking days
The total number of drinking days will be calculated using EMA data.
13 weeks
Slopes of key drinking factors over time(e.g., urge, mood, alcohol availability, motivation)
Analyses will determine the effects of tailored intervention messages (Smart-T app group) versus no intervention messages (Usual Care) on key drinking risk factors over time.
13 weeks
Secondary Outcomes (4)
Number of drinks per week
13 weeks
Number of heavy drinking days
13 weeks
Total number of drinking days
13 weeks
Alcohol-related problems
End of treatment and each follow-up assessment (i.e., 9, 13, and 26 weeks).
Study Arms (2)
Usual Care (UC)
ACTIVE COMPARATORAll 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.
Usual Care + Smart-T Alcohol
EXPERIMENTALThe 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.
Interventions
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.
Participants will receive standard shelter-based treatment (Usual Care) along with completing surveys and assessments.
Eligibility Criteria
You may qualify if:
- At least 18 years old
- or above on the AUDIT
- Receiving shelter-based services
- Consuming 1 or more standard drink of alcohol in the past week
- Score of 4 or higher on the REALM-SF
- Score under 8 on the 6CIT
You may not qualify if:
- Under 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2025
First Posted
February 11, 2025
Study Start
March 5, 2025
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
April 30, 2029
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
De-identified data will be shared via the NIMH Data Archive (NDA) and/or other repositories.