Clinical trial NCT03255317: SARA - Substance Abuse Research Assistant
Official title: Developing a Flexible App Data Collection Tool for Substance Use Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Keywords: Substance use, youth, mobile health, data collection adherence, user engagement
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Harvard University
First posted: 2017-08-21
Enrollment: 74
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: At each time point at which a participant is eligible to receive an engagement strategy, the participant is randomized to either receive the strategy or not receive the strategy. Participants are only eligible to potentially receive some engagement strategies after completing their self-report survey questions and/or active tasks that day (see "intervention" section for more information).
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the efficacy of engagement strategies for increasing daily data collection adherence among substance-using youth between the ages of 14 and 24. The primary hypotheses of this study are that: (1) receiving a reinforcer after completing daily data collection activities will predict next-day completion of targeted data collection activities; and (2) receiving a notification prior to 6pm (when data collection activities open) will predict same-day completion of data collection activities.

Detailed description: Substance use among adolescents and emerging adults remains an alarming public health issue which is associated with the leading causes of death. Although mobile applications are a promising data collection tool for understanding substance use among youth, existing mobile applications are limited in that they are not readily modifiable nor designed for long-term use. To address these challenges, our research team has developed a prototype mobile application named SARA (Substance Abuse Research Assistant) that contains multiple data collection tools (e.g., ecological momentary assessments, active tasks) and features various engagement strategies (reinforcers or notifications) designed to encourage data collection adherence over an extended period of time.

Baseline reinforcers which are administered to all participants include: (1) a virtual aquarium that participants see after opening the app; (2) virtual fish to populate the aquarium, which participants can earn points to unlock by completing daily data collection activities; (3) a new aquarium interface (i.e., leveling up) that participants unlock after using the app for a predetermined amount of time; (4) small financial rewards for each 3-day streak of completing daily data collection activities; and (5) reminder text messages/phone calls from research staff following predetermined reminder schedules. Key reinforcers and notifications are described in detail in the "intervention" section.

This study examines the impact of these key engagement strategies on participant compliance with daily data collection activities over a 30 day field testing period. The primary analyses will use a log linear generalization. The primary longitudinal binary outcome for the reinforcers will be whether on the following day the participant completes one or more self-report validated survey items. The secondary longitudinal binary outcome for the reinforcers will be whether on the following day the participant completes both active tasks. Survey questions answered prior to the randomization as well as the completion of one or more survey questions on the day prior to randomization, and the completion of both active tasks on the day prior to randomization, may be used as control variables in the above analyses of reinforcers. The primary longitudinal binary outcome for the notifications will be whether on the same day the participant completes one or more self-report survey questions. The secondary longitudinal binary outcome for the notifications will be whether on the same day the participant completes both active tasks. The completion of one or more survey questions on the day prior to, and the completion of both active tasks on the day prior to, the randomization will be included as control variables for the notifications.

Eligibility criteria: Inclusion criteria:

1. Between the ages of 14 and 24,
2. Has an Android or iPhone smartphone,
3. Self-reported past-month binge drinking (4 drinks for females/5 drinks for males on one occasion) and/or any past-month cannabis use in the absence of a medical marijuana card

Exclusion criteria:

1. Unable to understand English,
2. Not medically stable at intake,
3. Unable to provide informed consent/assent (e.g., cognitively impaired, intoxicated) at intake,
4. Parental consent cannot be obtained at intake (for participants age 14-17),
5. Unable to download the SARA app on smartphone at intake

Primary outcomes:
measure: Completion of daily self-report survey questions
timeFrame: Same day (2-8 hours later, depending on time of survey completion) for notifications; Next day (24 hours later) for reinforcers.
Secondary outcomes:
measure: Completion of daily active tasks
timeFrame: Same day (2-8 hours later, depending on time of survey completion) for notifications; Next day (24 hours later) for reinforcers.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Maureen Walton, MPH, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao P, Klasnja P, Tewari A, Murphy SA. Sample size calculations for micro-randomized trials in mHealth. Stat Med. 2016 May 30;35(12):1944-71. doi: 10.1002/sim.6847. Epub 2015 Dec 28.
citation: Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.
citation: Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.
citation: Rabbi M, Philyaw-Kotov M, Lee J, Mansour A, Dent L, Wang X, Cunningham R, Bonar E, Nahum-Shani I, Klasnja P, Walton M, Murphy S. SARA: A Mobile App to Engage Users in Health Data Collection. Proc ACM Int Conf Ubiquitous Comput. 2017 Sep;2017:781-789. doi: 10.1145/3123024.3125611.
citation: Nahum-Shani I, Rabbi M, Yap J, Philyaw-Kotov ML, Klasnja P, Bonar EE, Cunningham RM, Murphy SA, Walton MA. Translating strategies for promoting engagement in mobile health: A proof-of-concept microrandomized trial. Health Psychol. 2021 Dec;40(12):974-987. doi: 10.1037/hea0001101. Epub 2021 Nov 4.
citation: Rabbi M, Philyaw Kotov M, Cunningham R, Bonar EE, Nahum-Shani I, Klasnja P, Walton M, Murphy S. Toward Increasing Engagement in Substance Use Data Collection: Development of the Substance Abuse Research Assistant App and Protocol for a Microrandomized Trial Using Adolescents and Emerging Adults. JMIR Res Protoc. 2018 Jul 18;7(7):e166. doi: 10.2196/resprot.9850.