SARA - Substance Abuse Research Assistant

NCT03255317 | Completed

• 1 other identifier: HUM00121553
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use

Keywords

Substance use, youth, mobile health, data collection adherence, user engagement

Outcome Measures

Primary Outcomes (1)

• Completion of daily self-report survey questions

  Completion of daily self-report survey questions will be measured as "completed' or "not completed." Survey questions include validated items that assess daily mood and substance use. Completed = 1 or more questions answered; not completed = 0 questions answered.

  Same day (2-8 hours later, depending on time of survey completion) for notifications; Next day (24 hours later) for reinforcers.

Secondary Outcomes (1)

• Completion of daily active tasks

  Same day (2-8 hours later, depending on time of survey completion) for notifications; Next day (24 hours later) for reinforcers.

Study Arms (1)

Within-participant micro-randomization

EXPERIMENTAL

Intervention includes Reinforcers and Notifications through the app. At each available decision time, each participant is randomly assigned to either receive an engagement strategy or to not receive an engagement strategy.

Behavioral: Reinforcers; Behavioral: Notifications

Interventions

Reinforcers BEHAVIORAL

Memes/Gifs: Immediately after completing their daily ecological momentary assessment using the app, each participant is randomized to receive an inspirational or funny meme or gif that is displayed within the app. Life Insights: Immediately after completing both daily active tasks using the app, each participant is randomized to unlock a life insight. Life insights track data provided by the participant, are stored in a virtual library within the app, and are regularly updated with recent data points.

Within-participant micro-randomization

Notifications BEHAVIORAL

Reminder Push Notifications: All participants receive a push notification reminder from the app at 6pm (the time at which data collection opens) to complete their daily data collection activities. Each day, each participant will be randomized to receive either a generic reminder or a reminder that contains more detailed information (e.g., about upcoming incentives). Inspirational Push Notifications: Each day, each participant will be randomized to receive a push notification at 4pm that contains inspirational song lyrics or celebrity quotes.

Within-participant micro-randomization

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between the ages of 14 and 24,
• Has an Android or iPhone smartphone,
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Harvard University: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (6)

• 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.

  PMID: 26707831 BACKGROUND

• 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.

  PMID: 26651463 BACKGROUND

• 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.

  PMID: 27663578 BACKGROUND

• 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.

  PMID: 29503985 BACKGROUND

• 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.

  PMID: 34735165 DERIVED

• 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.

  PMID: 30021714 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Maureen Walton, MPH, PHD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 21, 2017
• Study Start: August 24, 2017
• Primary Completion: March 23, 2018
• Study Completion: April 13, 2018
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)