Recruiting
Phase 2
Phase 3

Smartphone-Based JITAI

Sponsor:

University of Oklahoma

Code:

NCT06821295

Conditions

Alcohol Misuse

Homeless

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Smart-T Alcohol

Usual Care

Study Details

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.

Conditions

Alcohol Misuse

Homeless

Study ID

NCT06821295

Start date

Mar 5, 2025

Status verified date

Apr, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • At least 18 years old
  • 8 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

Exclusion Criteria:

  • Under 18 years old
  • Not meeting other inclusion criteria

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Smart-T Alcohol

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

Participants will receive standard shelter-based treatment (Usual Care) along with completing surveys and assessments.

Primary outcome measure

  • Number of drinks per week [ Time Frame: 13 weeks ]
  • Number of heavy drinking days [ Time Frame: 13 weeks ]
  • Total number of drinking days [ Time Frame: 13 weeks ]
  • Slopes of key drinking factors over time(e.g., urge, mood, alcohol availability, motivation) [ Time Frame: 13 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

More Information

Sponsor

University of Oklahoma

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Just In Time Adaptive Intervention
  • Mobile Health
  • homeless
  • ecological momentary assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-05-01.