600 Participants Needed

Smartphone App for Alcoholism in Homeless Adults

(SmartT_A Trial)

KK
MB
Overseen ByMichael Businelle, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: University of Oklahoma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 who are experiencing homelessness, have an alcohol use disorder, and are currently receiving shelter-based services. Participants must be able to read at a basic level, have no significant cognitive impairment, and have consumed alcohol in the past week.

Inclusion Criteria

I am 18 years old or older.
My cognitive test score is below 8.
Scoring 8 or above on the AUDIT
See 3 more

Exclusion Criteria

Not meeting other inclusion criteria
I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Training and Baseline Monitoring

Participants receive training on the smartphone-based assessment platform and complete daily EMAs for baseline data collection

1 week
Daily EMAs

Treatment

Participants receive either Usual Care or Usual Care plus the Smart-T Alcohol intervention for alcohol use reduction

8 weeks
Daily EMAs

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up assessments

17 weeks
Assessments at weeks 9, 13, and 26

Treatment Details

Interventions

  • Smart-T Alcohol
Trial OverviewThe study tests if a smartphone app called Smart-T Alcohol can help reduce drinking when added to usual care in shelters. It sends tailored messages and content on-demand. The trial will compare results from this approach with those just receiving standard treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care + Smart-T AlcoholExperimental Treatment2 Interventions
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.
Group II: Usual Care (UC)Active Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+