- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03746808
Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention to Reduce Drinking Among Homeless Adults (Smart-T)
Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
An estimated 6.2% of US adults will be homeless at some point in their lifetime. Homeless adults have higher rates of disease, greater risk of interpersonal violence, shorter life expectancies, and disproportionately higher health care utilization and costs compared to housed individuals. A significant contributor to morbidity and mortality among homeless adults is the high prevalence of alcohol use. Approximately 33% of homeless adults have current alcohol dependence, a rate nearly 8 times that of the general population. Although shelter-based treatments are common, compliance is typically poor. Identifying factors that influence alcohol use would significantly improve the ability to develop effective interventions and engage homeless adults in treatment.
Relatively little is known about the environmental, cognitive, and behavioral antecedents of alcohol use in homeless adults. Like other subgroups, alcohol use has most often been examined using traditional lab/clinic based assessment methods that are not well suited to capturing the complicated street-level interactions experienced by most homeless adults. Traditional assessment methodologies may also provide biased and/or inaccurate estimates due to recall biases and errors in memory, particularly in this complicated population. Ecological momentary assessment (EMA), in which handheld devices (e.g., smartphones) are used to capture moment-to-moment experience, is currently the most accurate way to measure phenomena in natural settings. Additionally, recent technological advances have made it possible to collect continuous geolocation data alongside EMA. Researchers can now link environmental risks and protective factors to outcomes, without reliance on subjective reporting alone.
This pilot study will develop and test a "just-in-time" adaptive intervention to reduce alcohol use among homeless adults. Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults enrolled in shelter-based treatment for an AUD. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent alcohol use. Phase II will modify an existing app, previously validated for smoking cessation, to create the intervention. Phase III will pilot test the newly developed app for utility, satisfaction, and preliminary effectiveness in a group of 40 homeless adults with an AUD who are enrolled in shelter-based treatment. Alcohol consumption will be validated via a transdermal alcohol sensor (i.e., SCRAM) worn by participants in Phases I and III.
The central hypothesis is that alcohol use is strongly affected by moment-to-moment risk and protective factors. This study will be able to use EMAs to identify and automatically intervene during moments when people are at high risk for drinking. This hypothesis is based on preliminary findings among homeless, justice-involved, and socioeconomically disadvantaged safety-net hospital patients. If effective, this smartphone app could significantly improve treatment engagement, drinking outcomes, and quality of life among homeless adults with AUDs.
This project will:
- Use EMA to identify environmental (i.e., geolocation), cognitive, and behavioral antecedents of alcohol use among 80 homeless adults with an AUD who are receiving shelter-based treatment.
- Informed by Aim 1 findings, develop a "just-in-time" adaptive intervention to reduce alcohol use, including an alcohol use risk algorithm and corresponding theory-based treatment messages.
- Examine feasibility, acceptability, and preliminary effectiveness of a just-in-time adaptive smartphone app among 40 homeless adults with an AUD who are receiving shelter-based treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75201
- Bridge Homeless Recovery Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Score ≥ 8 on the AUDIT
- Report consuming ≥ 1 drink of alcohol in the past week
- Receiving treatment at Metrocare;
- Willing and able to complete the baseline and follow-up visits;
- Score ≥ 4 on the REALM-SF, indicating > 6th grade English literacy level
- Score ≥ 24 on the Mini-Mental State Exam
Exclusion Criteria:
- Circulation problems, neuropathy, deep vein thrombosis, leg ulcers, tendonitis, diabetes, pregnancy, history of swelling or nickel or other metal allergies that would prohibit wearing the SCRAM ankle bracelet.
- Self-reported discomfort wearing an alcohol sensing bracelet for 4 weeks.
- Previously participated in Phase I (for Phase III recruitment).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: EMA only
Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are receiving shelter-based treatment.
|
This study will develop and test a "just-in-time" adaptive intervention to reduce alcohol use among homeless adults.
Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are enrolled in shelter-based treatment.
Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent alcohol use.
|
Active Comparator: EMA + App/Treatment Messages
Phase III will pilot test the newly developed app for utility, satisfaction, and preliminary effectiveness in a group of 40 homeless adults with an AUD who are receiving shelter-based treatment.
The investigators will compare Phase III participants (i.e., received Metrocare, EMAs, and tailored treatment messages) to Phase I participants (i.e., received Metrocare and EMAs only) to examine the preliminary effectiveness of the app.
|
This study will develop and test a "just-in-time" adaptive intervention to reduce alcohol use among homeless adults.
Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are enrolled in shelter-based treatment.
Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent alcohol use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction With App Treatment Messages
Time Frame: 4 weeks
|
Satisfaction with app on self-reported questions at follow-up (1-5 scale where 1 = Not at all; and 5 = Extremely)
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Drinking Days
Time Frame: 4 weeks
|
Number of drinking days (number of days with any self-reported drinking out of 28 days)
|
4 weeks
|
Number of Heavy Drinking Days
Time Frame: 4 weeks
|
Number of drinking days (number of days with self-reported >4 drinks for men; >3 drinks for women out of 28 days)
|
4 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Scott Walters, PhD, University of North Texas Health Science Center
Publications and helpful links
General Publications
- Walters ST, Mun EY, Tan Z, Luningham JM, Hebert ET, Oliver JA, Businelle MS. Development and preliminary effectiveness of a smartphone-based, just-in-time adaptive intervention for adults with alcohol misuse who are experiencing homelessness. Alcohol Clin Exp Res. 2022 Sep;46(9):1732-1741. doi: 10.1111/acer.14908. Epub 2022 Aug 7.
- Walters ST, Businelle MS, Suchting R, Li X, Hebert ET, Mun EY. Using machine learning to identify predictors of imminent drinking and create tailored messages for at-risk drinkers experiencing homelessness. J Subst Abuse Treat. 2021 Aug;127:108417. doi: 10.1016/j.jsat.2021.108417. Epub 2021 Apr 20.
- Mun EY, Li X, Businelle MS, Hebert ET, Tan Z, Barnett NP, Walters ST. Ecological Momentary Assessment of Alcohol Consumption and Its Concordance with Transdermal Alcohol Detection and Timeline Follow-Back Self-report Among Adults Experiencing Homelessness. Alcohol Clin Exp Res. 2021 Apr;45(4):864-876. doi: 10.1111/acer.14571. Epub 2021 Mar 3.
- Businelle MS, Walters ST, Mun EY, Kirchner TR, Hebert ET, Li X. Reducing Drinking Among People Experiencing Homelessness: Protocol for the Development and Testing of a Just-in-Time Adaptive Intervention. JMIR Res Protoc. 2020 Apr 16;9(4):e15610. doi: 10.2196/15610.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34AA024584-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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