<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03255317</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00121553</org_study_id>
    <nct_id>NCT03255317</nct_id>
  </id_info>
  <brief_title>SARA - Substance Abuse Research Assistant</brief_title>
  <acronym>SARA</acronym>
  <official_title>Developing a Flexible App Data Collection Tool for Substance Use Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the efficacy of engagement strategies for increasing&#xD;
      daily data collection adherence among substance-using youth between the ages of 14 and 24.&#xD;
      The primary hypotheses of this study are that: (1) receiving a reinforcer after completing&#xD;
      daily data collection activities will predict next-day completion of targeted data collection&#xD;
      activities; and (2) receiving a notification prior to 6pm (when data collection activities&#xD;
      open) will predict same-day completion of data collection activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Substance use among adolescents and emerging adults remains an alarming public health issue&#xD;
      which is associated with the leading causes of death. Although mobile applications are a&#xD;
      promising data collection tool for understanding substance use among youth, existing mobile&#xD;
      applications are limited in that they are not readily modifiable nor designed for long-term&#xD;
      use. To address these challenges, our research team has developed a prototype mobile&#xD;
      application named SARA (Substance Abuse Research Assistant) that contains multiple data&#xD;
      collection tools (e.g., ecological momentary assessments, active tasks) and features various&#xD;
      engagement strategies (reinforcers or notifications) designed to encourage data collection&#xD;
      adherence over an extended period of time.&#xD;
&#xD;
      Baseline reinforcers which are administered to all participants include: (1) a virtual&#xD;
      aquarium that participants see after opening the app; (2) virtual fish to populate the&#xD;
      aquarium, which participants can earn points to unlock by completing daily data collection&#xD;
      activities; (3) a new aquarium interface (i.e., leveling up) that participants unlock after&#xD;
      using the app for a predetermined amount of time; (4) small financial rewards for each 3-day&#xD;
      streak of completing daily data collection activities; and (5) reminder text messages/phone&#xD;
      calls from research staff following predetermined reminder schedules. Key reinforcers and&#xD;
      notifications are described in detail in the &quot;intervention&quot; section.&#xD;
&#xD;
      This study examines the impact of these key engagement strategies on participant compliance&#xD;
      with daily data collection activities over a 30 day field testing period. The primary&#xD;
      analyses will use a log linear generalization. The primary longitudinal binary outcome for&#xD;
      the reinforcers will be whether on the following day the participant completes one or more&#xD;
      self-report validated survey items. The secondary longitudinal binary outcome for the&#xD;
      reinforcers will be whether on the following day the participant completes both active tasks.&#xD;
      Survey questions answered prior to the randomization as well as the completion of one or more&#xD;
      survey questions on the day prior to randomization, and the completion of both active tasks&#xD;
      on the day prior to randomization, may be used as control variables in the above analyses of&#xD;
      reinforcers. The primary longitudinal binary outcome for the notifications will be whether on&#xD;
      the same day the participant completes one or more self-report survey questions. The&#xD;
      secondary longitudinal binary outcome for the notifications will be whether on the same day&#xD;
      the participant completes both active tasks. The completion of one or more survey questions&#xD;
      on the day prior to, and the completion of both active tasks on the day prior to, the&#xD;
      randomization will be included as control variables for the notifications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Actual">April 13, 2018</completion_date>
  <primary_completion_date type="Actual">March 23, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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 &quot;intervention&quot; section for more information).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Completion of daily self-report survey questions</measure>
    <time_frame>Same day (2-8 hours later, depending on time of survey completion) for notifications; Next day (24 hours later) for reinforcers.</time_frame>
    <description>Completion of daily self-report survey questions will be measured as &quot;completed' or &quot;not completed.&quot; Survey questions include validated items that assess daily mood and substance use. Completed = 1 or more questions answered; not completed = 0 questions answered.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Completion of daily active tasks</measure>
    <time_frame>Same day (2-8 hours later, depending on time of survey completion) for notifications; Next day (24 hours later) for reinforcers.</time_frame>
    <description>Completion of daily active tasks will be measured as &quot;completed' or &quot;not completed&quot;. Completed = 2 tasks; not completed = 1 or 0 tasks</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Substance Use</condition>
  <arm_group>
    <arm_group_label>Within-participant micro-randomization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reinforcers</intervention_name>
    <description>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.</description>
    <arm_group_label>Within-participant micro-randomization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Notifications</intervention_name>
    <description>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.</description>
    <arm_group_label>Within-participant micro-randomization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Between the ages of 14 and 24,&#xD;
&#xD;
          2. Has an Android or iPhone smartphone,&#xD;
&#xD;
          3. Self-reported past-month binge drinking (4 drinks for females/5 drinks for males on&#xD;
             one occasion) and/or any past-month cannabis use in the absence of a medical marijuana&#xD;
             card&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Unable to understand English,&#xD;
&#xD;
          2. Not medically stable at intake,&#xD;
&#xD;
          3. Unable to provide informed consent/assent (e.g., cognitively impaired, intoxicated) at&#xD;
             intake,&#xD;
&#xD;
          4. Parental consent cannot be obtained at intake (for participants age 14-17),&#xD;
&#xD;
          5. Unable to download the SARA app on smartphone at intake&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maureen Walton, MPH, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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>
    <PMID>26707831</PMID>
  </reference>
  <reference>
    <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>
    <PMID>26651463</PMID>
  </reference>
  <reference>
    <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>
    <PMID>27663578</PMID>
  </reference>
  <reference>
    <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>
    <PMID>29503985</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>April 17, 2018</last_update_submitted>
  <last_update_submitted_qc>April 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Maureen A Walton</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Substance use, youth, mobile health, data collection adherence, user engagement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03255317
org study id: HUM00121553
nct id: NCT03255317
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
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
masking: None (Open Label)
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.
description: 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.
measure: 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.
description: Completion of daily active tasks will be measured as "completed' or "not completed". Completed = 2 tasks; not completed = 1 or 0 tasks
arm group label: Within-participant micro-randomization
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Reinforcers
description: 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.
arm group label: Within-participant micro-randomization
intervention type: Behavioral
intervention name: Notifications
description: 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.
arm group label: Within-participant micro-randomization
criteria: 
gender: All
minimum age: 14 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maureen Walton, MPH, PHD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
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.
PMID: 26707831
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.
PMID: 26651463
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.
PMID: 27663578
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.
PMID: 29503985
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Maureen A Walton
investigator title: Professor
mesh term: Substance-Related Disorders
sharing ipd: No