xml: <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/NCT05979272</url>
    </required_header>
    <id_info>
      <org_study_id>SP0078326</org_study_id>
      <secondary_id>K23DA048062</secondary_id>
      <nct_id>NCT05979272</nct_id>
    </id_info>
    <brief_title>TECH App Marijuana Use Intervention for Court-Involved Adolescents</brief_title>
    <acronym>TECH</acronym>
    <official_title>Development and Preliminary Testing of an Adjunct Smartphone App to Reduce Marijuana Use in Court-Involved, Non-Incarcerated Adolescents</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Northwestern University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Brown University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Rhode Island Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Northwestern University</source>
    <oversight_info>
      <has_dmc>Yes</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 study is about helping teens who are involved in the court system to cut down or quit&#xD;
        using marijuana. Teens may be asked to test out an experimental smartphone app, called TECH,&#xD;
        that will be used only by teens in this study. This app is a private online community where&#xD;
        teens can work towards changing their substance use and other behavior with the help of other&#xD;
        anonymous teens. We will use this information to learn how the app may help teens make a&#xD;
        change and to improve the TECH app.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This multiphase study will establish the feasibility, acceptability, and preliminary efficacy&#xD;
        of a novel smartphone app that leverages both intrapersonal and interpersonal mechanisms to&#xD;
        promote cannabis-related behavior change among CINI youth ages 14-17. The app, Teen&#xD;
        Empowerment through Computerized Health (TECH), will be evaluated as an adjunct to treatment&#xD;
        as usual (TAU) at the local family court. Phase 1 (completed Fall 2021) included a series of&#xD;
        semi-structured interviews with key individuals, to inform how clinical goals (e.g., reduced&#xD;
        cannabis use) will map onto usage goals (e.g., goal-setting, peer networking), features&#xD;
        (e.g., expert-moderated forum, notifications) and workflow. Then, Phase 2 (completed Fall&#xD;
        2022) beta tested and iteratively refined the TECH prototype with 10 court-involved,&#xD;
        non-incarcerated (CINI) youth. In the current phase of the work, Phase 3, we will conduct a&#xD;
        pilot randomized control trial (RCT) with 60 CINI youth to test the TECH app (TAU+TECH)&#xD;
        relative to TAU-only.&#xD;
  &#xD;
        Specific aims are:&#xD;
  &#xD;
        Aim 1. Apply the Behavior Intervention Theory model to develop a user-driven tool (i.e.,&#xD;
        TECH) that capitalizes on how, why, and when CINI youth would most prefer to engage with a&#xD;
        smartphone app to reduce cannabis use.&#xD;
  &#xD;
        ~Aim 1 was achieved in Phase 1 qualitative interviews with CINI youth, their parents, and&#xD;
        behavioral health app developers.&#xD;
  &#xD;
        Aim 2. Examine the feasibility and acceptability of the TECH user-driven smartphone app.&#xD;
  &#xD;
        ~Hypothesis 1 is that TECH will be feasible and acceptable to CINI youth, as measured via&#xD;
        enrollment and withdrawal rates, app usage data, and exit interviews. Aim 2 will be achieved&#xD;
        through Phase 2 beta testing (n = 10) and Phase 3's pilot RCT (n = 60) with CINI youth.&#xD;
  &#xD;
        Aim 3. Test the preliminary efficacy of the TECH smartphone app as an adjunct to TAU (TECH +&#xD;
        TAU vs. TAU-only) on cannabis use (primary outcome).&#xD;
  &#xD;
        ~Hypothesis 2 is that, relative to CINI youth who receive TAU-only, the TAU+TECH group will&#xD;
        demonstrate greater reductions in cannabis use. Aim 3 will be achieved via Phase 3's pilot&#xD;
        RCT (n = 60 CINI youth).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 21, 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in days of cannabis use (Preliminary Efficacy)</measure>
      <time_frame>Last 90 days at baseline, and 1-, 3-, and 6-months</time_frame>
      <description>Self-report of total days of cannabis use, via Timeline Followback Interview</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Cannabis Use</condition>
    <condition>Adolescent</condition>
    <arm_group>
      <arm_group_label>TAU-only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Treatment as usual</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TAU + TECH</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment as usual, plus TECH app</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Treatment as usual</intervention_name>
      <description>Treatment as Usual at the local family court, which includes a brief, computerized motivation enhancement intervention. All CINI youth will receive TAU, regardless of condition.</description>
      <arm_group_label>TAU + TECH</arm_group_label>
      <arm_group_label>TAU-only</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Teen Empowerment through Computerized Health (TECH) app</intervention_name>
      <description>An adjunct smartphone app (i.e., TECH) developed to support TAU. All participants randomly assigned to TAU+TECH will receive the TECH app.</description>
      <arm_group_label>TAU + TECH</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 14 years to 18 years&#xD;
  &#xD;
            -  Able to speak and read English&#xD;
  &#xD;
            -  Have access to a smartphone&#xD;
  &#xD;
            -  Self-report past-year cannabis use&#xD;
  &#xD;
            -  If a minor, able to provide parental consent and child assent&#xD;
  &#xD;
          Exclusion Criteria for all participants is limited to conditions that would preclude active&#xD;
          participation in an intervention study of a mobile app (e.g., psychosis, cognitive&#xD;
          impairment, visual impairment).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Northwestern University Feinberg School of Medicine</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60614</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Rhode Island Hospital</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60614</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Rhode Island Family Court</name>
        <address>
          <city>Providence</city>
          <state>Rhode Island</state>
          <zip>02903</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kathleen Kemp, PhD</last_name>
        <phone>401-793-8269</phone>
        <email>techstudy@brown.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Brown University</name>
        <address>
          <city>Providence</city>
          <state>Rhode Island</state>
          <zip>02912</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sarah Helseth, PhD</last_name>
        <phone>401-863-6881</phone>
        <email>techstudy@brown.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Helseth SA, Guigayoma J, Price D, Spirito A, Clark MA, Barnett NP, Becker SJ. Developing a Smartphone-Based Adjunct Intervention to Reduce Cannabis Use Among Juvenile Justice-Involved Adolescents: Protocol for a Multiphase Study. JMIR Res Protoc. 2022 Mar 11;11(3):e35402. doi: 10.2196/35402.</citation>
      <PMID>35275086</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Northwestern University</investigator_affiliation>
      <investigator_full_name>Sarah Helseth</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Court-involved</keyword>
    <keyword>cannabis use</keyword>
    <keyword>adolescent</keyword>
    <keyword>marijuana use</keyword>
    <keyword>digital health</keyword>
    <keyword>mHealth</keyword>
    <keyword>smartphone</keyword>
    <keyword>juvenile justice</keyword>
    <keyword>juvenile legal</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Marijuana Abuse</mesh_term>
      <mesh_term>Marijuana Use</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979272
  org study id: SP0078326
  secondary id: K23DA048062
  nct id: NCT05979272
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The study is about helping teens who are involved in the court system to cut down or quit
        using marijuana. Teens may be asked to test out an experimental smartphone app, called TECH,
        that will be used only by teens in this study. This app is a private online community where
        teens can work towards changing their substance use and other behavior with the help of other
        anonymous teens. We will use this information to learn how the app may help teens make a
        change and to improve the TECH app.
  This multiphase study will establish the feasibility, acceptability, and preliminary efficacy
        of a novel smartphone app that leverages both intrapersonal and interpersonal mechanisms to
        promote cannabis-related behavior change among CINI youth ages 14-17. The app, Teen
        Empowerment through Computerized Health (TECH), will be evaluated as an adjunct to treatment
        as usual (TAU) at the local family court. Phase 1 (completed Fall 2021) included a series of
        semi-structured interviews with key individuals, to inform how clinical goals (e.g., reduced
        cannabis use) will map onto usage goals (e.g., goal-setting, peer networking), features
        (e.g., expert-moderated forum, notifications) and workflow. Then, Phase 2 (completed Fall
        2022) beta tested and iteratively refined the TECH prototype with 10 court-involved,
        non-incarcerated (CINI) youth. In the current phase of the work, Phase 3, we will conduct a
        pilot randomized control trial (RCT) with 60 CINI youth to test the TECH app (TAU+TECH)
        relative to TAU-only.
  
        Specific aims are:
  
        Aim 1. Apply the Behavior Intervention Theory model to develop a user-driven tool (i.e.,
        TECH) that capitalizes on how, why, and when CINI youth would most prefer to engage with a
        smartphone app to reduce cannabis use.
  
        ~Aim 1 was achieved in Phase 1 qualitative interviews with CINI youth, their parents, and
        behavioral health app developers.
  
        Aim 2. Examine the feasibility and acceptability of the TECH user-driven smartphone app.
  
        ~Hypothesis 1 is that TECH will be feasible and acceptable to CINI youth, as measured via
        enrollment and withdrawal rates, app usage data, and exit interviews. Aim 2 will be achieved
        through Phase 2 beta testing (n = 10) and Phase 3's pilot RCT (n = 60) with CINI youth.
  
        Aim 3. Test the preliminary efficacy of the TECH smartphone app as an adjunct to TAU (TECH +
        TAU vs. TAU-only) on cannabis use (primary outcome).
  
        ~Hypothesis 2 is that, relative to CINI youth who receive TAU-only, the TAU+TECH group will
        demonstrate greater reductions in cannabis use. Aim 3 will be achieved via Phase 3's pilot
        RCT (n = 60 CINI youth).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in days of cannabis use (Preliminary Efficacy)
  time frame: Last 90 days at baseline, and 1-, 3-, and 6-months
  description: Self-report of total days of cannabis use, via Timeline Followback Interview
  arm group label: TAU-only
  arm group type: Active Comparator
  description: Treatment as usual
  arm group label: TAU + TECH
  arm group type: Experimental
  description: Treatment as usual, plus TECH app
  intervention type: Behavioral
  intervention name: Treatment as usual
  description: Treatment as Usual at the local family court, which includes a brief, computerized motivation enhancement intervention. All CINI youth will receive TAU, regardless of condition.
  arm group label: TAU + TECH
  arm group label: TAU-only
  intervention type: Behavioral
  intervention name: Teen Empowerment through Computerized Health (TECH) app
  description: An adjunct smartphone app (i.e., TECH) developed to support TAU. All participants randomly assigned to TAU+TECH will receive the TECH app.
  arm group label: TAU + TECH
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 18 Years
  healthy volunteers: No
  facility: 
  status: Active, not recruiting
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  citation: Helseth SA, Guigayoma J, Price D, Spirito A, Clark MA, Barnett NP, Becker SJ. Developing a Smartphone-Based Adjunct Intervention to Reduce Cannabis Use Among Juvenile Justice-Involved Adolescents: Protocol for a Multiphase Study. JMIR Res Protoc. 2022 Mar 11;11(3):e35402. doi: 10.2196/35402.
  PMID: 35275086
  responsible party type: Principal Investigator
  investigator affiliation: Northwestern University
  investigator full name: Sarah Helseth
  investigator title: Assistant Professor
  mesh term: Marijuana Abuse
  mesh term: Marijuana Use
  sharing ipd: No