Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention to Reduce Drinking Among Homeless Adults

NCT03746808 | Completed Results

• 1 other identifier: 1R34AA024584-01A1
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

Homeless adults are 8 times as likely to be alcohol dependent compared with adults in the general population, yet few studies have examined the precipitants of alcohol use in this vulnerable population. Ecological momentary assessments (EMAs) that involve repeated assessment of thoughts/mood/behaviors (e.g., via smart phone) is currently the most accurate way to assess individuals in real-time in their natural environments. Advances in smartphone technology also allow for the collection of continuous geolocation and other passive sensing data. Thus, researchers can now link environmental risks and protective factors to outcomes, without reliance on subjective reporting alone. Building on prior work, this study will use a three-phase study to develop and test a "just in time" adaptive intervention to reduce alcohol use in homeless men and women. Phase I will use smartphones and passive sensing technologies to monitor geolocation, psychosocial variables (e.g., stress, affect, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are receiving shelter-based treatment. Phase I will identify environmental (i.e., geolocation), cognitive, and behavioral antecedents of alcohol use over 4 weeks. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent drinking. The resulting app will assess imminent risk of alcohol use after each EMA and will deliver relevant treatment messages that match a person's current risk factors. Phase III will test the feasibility, acceptability and preliminary efficacy of the app in a sample of 40 homeless adults with an AUD who receive the EMA plus treatment messages over 4 weeks. Drinking will be determined via self-report, supplemented by a transdermal alcohol sensor (i.e., SCRAM) worn by participants. This project will be the first to combine geolocation and psychosocial variables to identify real-time antecedents of drinking. If effective, this smartphone app could significantly improve treatment engagement, drinking outcomes, and quality of life among homeless adults with alcohol use disorders.

Conditions

Alcohol Use Disorder; Treatment; Homelessness

Outcome Measures

Primary Outcomes (1)

• Satisfaction With App Treatment Messages

  Satisfaction with app on self-reported questions at follow-up (1-5 scale where 1 = Not at all; and 5 = Extremely)

  4 weeks

Secondary Outcomes (2)

• Number of Drinking Days

  4 weeks

• Number of Heavy Drinking Days

  4 weeks

Study Arms (2)

EMA only

PLACEBO COMPARATOR

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.

Behavioral: EMA + App/Treatment Messages

EMA + App/Treatment Messages

ACTIVE COMPARATOR

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.

Behavioral: EMA + App/Treatment Messages

Interventions

EMA + App/Treatment Messages BEHAVIORAL

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.

EMA + App/Treatment Messages; EMA only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of North Texas Health Science Center: lead
• University of Oklahoma: collaborator

Study Sites (1)

Bridge Homeless Recovery Center

Dallas, Texas, 75201, United States

Location

Related Publications (4)

• 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.

  PMID: 35869820 RESULT

• 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.

  PMID: 34134874 RESULT

• 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.

  PMID: 33583057 RESULT

• 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.

  PMID: 32297874 RESULT

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Scott Walters
• Organization: University of North Texas Health Sciece Center

scott.walters@unthsc.edu

817-735-2365

Study Officials

• Scott Walters, PhD

  University of North Texas Health Science Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regents Professor

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 20, 2018
• Study Start: February 14, 2019
• Primary Completion: July 30, 2021
• Study Completion: May 31, 2022
• Last Updated: November 18, 2022
• Results First Posted: November 18, 2022

Record last verified: 2022-11

Locations

US (1)