SARA - Substance Abuse Research Assistant

Not Applicable

Completed

• Conditions: Substance Use
• Interventions: Behavioral: Reinforcers; Behavioral: Notifications

• Registration Number: NCT03255317
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-21
• Study Start: 2017-08-24
• Primary Completion: 2018-03-23
• Status Verified: 2018-04
• Study Completion: 2018-04-13
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Within-participant micro-randomization	Notifications	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.
Within-participant micro-randomization	Reinforcers	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.

Primary Outcome Measures

Name	Time	Method
Completion of daily self-report survey questions	Same day (2-8 hours later, depending on time of survey completion) for notifications; Next day (24 hours later) for reinforcers.	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.

Secondary Outcome Measures

Name	Time	Method
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.	Completion of daily active tasks will be measured as "completed' or "not completed". Completed = 2 tasks; not completed = 1 or 0 tasks

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States