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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oklahoma

About 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 accepts healthy volunteers

Qualifiers

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

Disqualifiers

Under 18 years old

Not meeting other inclusion criteria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Smart-T Alcohol

    Other intervention

    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 intervention

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

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Usual Care (UC)Active comparator 1 intervention
Group B: Usual Care + Smart-T AlcoholExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of drinks per week

The number of drinks per week reported during daily EMAs.

Time frame
13 weeks
2

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).

Time frame
13 weeks
3

Total number of drinking days

The total number of drinking days will be calculated using EMA data.

Time frame
13 weeks
4

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.

Time frame
13 weeks

Secondary outcomes

1

Number of drinks per week

The number of drinks per week will be calculated using timeline follow-back data.

Time frame
13 weeks
2

Number of heavy drinking days

The number of heavy drinking days will be calculated using timeline follow-back data.

Time frame
13 weeks
3

Total number of drinking days

The total number of drinking days will be calculated using timeline follow-back data.

Time frame
13 weeks
4

Alcohol-related problems

Total scores on the end of treatment Short Inventory of Problems (SIP) measure controlling for baseline SIP scores.

Time frame
End of treatment and each follow-up assessment (i.e., 9, 13, and 26 weeks).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator