Substance UseSARANCT03255317
SARA - Substance Abuse Research Assistant
A study testing Reinforcers and Notifications in people with Substance Use, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- Reinforcers and Notifications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2017to 13 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Flexible App Data Collection Tool for Substance Use Research
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.
Read the 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.
- Conditions
- Substance Use
- Being tested
- Reinforcers, Notifications
- Keywords
- Substance use, youth, mobile health, data collection adherence, user engagement
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReinforcersBehavioural
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.
NotificationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Reinforcers; Behavioral: Notifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Completion of daily active tasks will be measured as "completed' or "not completed". Completed = 2 tasks; not completed = 1 or 0 tasks
Measured: Same day (2-8 hours later, depending on time of survey completion) for notifications; Next day (24 hours later) for reinforcers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start24 Aug 2017
- Primary completion23 Mar 2018
- Study completion13 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University
- Responsible party
- Principal investigator, Maureen A Walton, University of Michigan
- Investigators
- Maureen Walton, MPH, PHD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255317
- Sponsor's protocol ID
- HUM00121553
- Acronym
- SARA
- Status last verified
- Apr 2018
- First submitted
- 14 Aug 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26707831Klasnja 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.
PubMed 26651463Nahum-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.
PubMed 27663578Rabbi 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.
PubMed 29503985Nahum-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.
PubMed 34735165Rabbi 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.
PubMed 30021714
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Flexible App Data Collection Tool for Substance Use Research
- ClinicalTrials.gov ID
- NCT03255317
- Acronym / sponsor ID
- SARA / HUM00121553
- Conditions
- Substance Use
- Keywords
- Substance use, youth, mobile health, data collection adherence, user engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Harvard University
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Within-participant micro-randomization | Experimental | Behavioral: Reinforcers, Behavioral: NotificationsIntervention 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. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReinforcersMemes/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. | Behavioural | Within-participant micro-randomization |
| NotificationsReminder 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. | Behavioural | Within-participant micro-randomization |
Primary outcome
Completion of daily self-report survey questions
Time frame: 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.
1 secondary outcome
Completion of daily active tasks
Time frame: Same day (2-8 hours later, depending on time of survey completion) for notifications; Next day (24 hours later) for reinforcers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 26707831Liao 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.
- Background: PubMed 26651463Klasnja 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.
- Background: PubMed 27663578Nahum-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.
- Background: PubMed 29503985Rabbi 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.
- Derived from this study: PubMed 34735165Nahum-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.
- Derived from this study: PubMed 30021714Rabbi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen Walton, MPH, PHD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reinforcers and Notifications in people with Substance Use, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of daily self-report survey questions (time frame: Same day (2-8 hours later, depending on time of survey completion) for notifications; Next day (24 hours later) for reinforcers.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03255317, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018; AzTrials last refreshed its copy on 26 Oct 2026.