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/NCT05991882</url>
    </required_header>
    <id_info>
      <org_study_id>R34DA056759</org_study_id>
      <secondary_id>R34DA056759</secondary_id>
      <nct_id>NCT05991882</nct_id>
    </id_info>
    <brief_title>Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults</brief_title>
    <acronym>SAFERR</acronym>
    <official_title>Mobile Adaptive Intervention to Reduce Negative Consequences Associated With Simultaneous Alcohol and Marijuana Use in Young Adults in Primary Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kaiser Permanente</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Kaiser Permanente</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 goal of this treatment development project is to develop an adaptive ecological momentary&#xD;
        intervention (a-EMI) for young adults using marijuana and alcohol that is grounded in&#xD;
        self-regulation and social cognitive theories. To determine the most efficacious intervention&#xD;
        strategies, the investigators will test variations of intervention components to identify the&#xD;
        best combination. The study will take place at the Center for Integrated Health Care Research&#xD;
        at Kaiser Permanente Hawaii (KPHI), located in Honolulu (island of Oahu). Following pilot&#xD;
        testing with 6 participants, the study team will assess the feasibility and efficacy of&#xD;
        intervention components on two primary outcomes (negative consequences and protective&#xD;
        behavioral strategies [PBS]) using a fractional factorial experimental design, with&#xD;
        post-intervention assessment and one- and three-month follow-ups. 136 diverse young adults&#xD;
        recruited from KPHI who report current simultaneous alcohol and marijuana (SAM) use will be&#xD;
        randomly assigned to one of eight groups, representing experimental conditions that include&#xD;
        or do not include intervention strategies focused on craving reduction and PBS. As a result&#xD;
        of this process, individual and/or combined components that lead to improved outcomes will be&#xD;
        retained in a subsequent randomized controlled trial, while ineffective components will be&#xD;
        eliminated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Up to one-third of young adults report use of marijuana or alcohol in the past month, with&#xD;
        sizable numbers reporting daily marijuana use and heavy episodic drinking. Simultaneous&#xD;
        alcohol and marijuana (SAM) use, defined as use of both substances at the same time or within&#xD;
        a few hours of each other with overlapping effects, is common among young adults. Recent&#xD;
        research has shown that SAM use leads to greater negative consequences compared to use of&#xD;
        either substance alone. No current intervention addresses SAM use specifically and few&#xD;
        leverage new technological methods (e.g., smartphones) or strategies (e.g., protective&#xD;
        behavioral strategies [PBS]) to engage young adults.&#xD;
  &#xD;
        The goal of this Stage I treatment development project is to develop a fully mobile adaptive&#xD;
        ecological momentary intervention (a-EMI) titled &quot;Smartphone App For Effectively Reducing&#xD;
        Risk (SAFERR)&quot; that is grounded in self-regulation and social cognitive theories. To&#xD;
        determine the most efficacious intervention strategies, the investigators will test&#xD;
        variations of intervention components to identify the best combination. They will assess the&#xD;
        feasibility and efficacy of intervention components on two outcomes (negative consequences&#xD;
        and PBS) using a fractional factorial experimental design.&#xD;
  &#xD;
        The study will take place at the Center for Integrated Health Care Research at Kaiser&#xD;
        Permanente Hawaii (KPHI), located in Honolulu (island of Oahu). Following pilot testing, the&#xD;
        SAFERR a-EMI will be administered to 6 eligible participants. Based on the feedback, the app&#xD;
        will be revised and a trial of the SAFERR intervention will begin. 136 diverse young adults&#xD;
        who report current SAM use will be recruited from primary care clinics at KPHI. Eligible&#xD;
        individuals will complete a baseline assessment and then be randomly assigned (by sex) to one&#xD;
        of eight conditions using stratified randomization. Each condition either includes or does&#xD;
        not include four different intervention strategies focused on craving reduction and PBS. All&#xD;
        participants will complete signal-contingent (random prompts three times per day) and&#xD;
        event-related ecological momentary assessment (EMA) for 6 weeks using a smartphone&#xD;
        application (app). EMA will continue during the 4-week intervention phase. At the beginning&#xD;
        of the intervention, all participants will complete an introduction module via the study app&#xD;
        that includes psychoeducation, personalized feedback, and goal setting. Participants will&#xD;
        then begin the a-EMI via the study app, with components delivered based on their condition&#xD;
        assignment.&#xD;
  &#xD;
        Following completion of the intervention, participants will complete a post-intervention&#xD;
        assessment and follow-up assessments at one- and three-months. The feasibility of the a-EMI&#xD;
        and design will be examined by assessing: study attrition and response rates/time, module&#xD;
        completion rates, acceptability (satisfaction, usability), perceived helpfulness, goal&#xD;
        attainment, and implementation and intervention engagement. The efficacy of intervention&#xD;
        components on negative consequences and PBS during EMA and at post-intervention and one-month&#xD;
        and three-month follow-ups will be examined. In a future, larger study, the most useful&#xD;
        components will be incorporated into a full intervention package and tested in a randomized&#xD;
        controlled trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 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>Factorial Assignment</intervention_model>
      <intervention_model_description>Participants will be randomly assigned to one of eight conditions</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participants in the factorial trial will be informed generally of the assigned condition (i.e., introduction module + no daily messages or introduction module + daily messages), but not given detailed content.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Negative consequences associated with alcohol, marijuana, and simultaneous alcohol and marijuana (SAM) use</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>Changes in negative consequences will be assessed using a measure that assesses alcohol, marijuana, and SAM use negative consequences. Items are rated dichotomously (yes/no).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Protective behavioral strategies for alcohol</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>Changes in protective behavioral strategies for alcohol will be assessed using the Protective Drinking Practices Scale (PDPS), which assesses use of protective behavioral strategies related to alcohol on a 1 (never) to 6 (always) scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Protective behavioral strategies for marijuana</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>Changes in protective behavioral strategies for marijuana will be assessed using the Protective Behavioral Strategies for Marijuana (PBSM) Scale, which assesses use of protective behavioral strategies related to marijuana on a 1 (never) to 6 (always) scale.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Feasibility - study attrition</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>Number of completed study phases, including six weeks of ecological momentary assessment (EMA), the 4-week a-EMI period, post-intervention assessment, and one- and three-month follow-up assessments.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility - response rate</measure>
      <time_frame>Week 7</time_frame>
      <description>Number of completed prompts across 6-week EMA</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility - module completion rate</measure>
      <time_frame>Week 7</time_frame>
      <description>Completion of introduction module focused on psychoeducation, personalized feedback, and goal setting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility - acceptability of the intervention</measure>
      <time_frame>Week 7</time_frame>
      <description>The revised Client Satisfaction Questionnaire (CSQ-8) will assess satisfaction with the intervention, perceptions of format and language of the a-EMI messages, and usability of the a-EMI (e.g., manner in which information was presented, language, question/intervention strategy comprehension, strategy delivery, timing, and study and a-EMI burden).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility - perceived helpfulness of intervention strategies</measure>
      <time_frame>Week 7</time_frame>
      <description>A Feedback Measure will assess perceptions of the helpfulness of particular intervention strategies, as well as other useful strategies that could be added.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility - intervention implementation</measure>
      <time_frame>Week 7</time_frame>
      <description>Intervention implementation will be examined through a short survey that will assess the ease of app use and accessibility, any challenges requesting strategies when needed, and any problems with the technology.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility - intervention engagement</measure>
      <time_frame>Week 7</time_frame>
      <description>Intervention engagement will be assessed by examining participant's use of intervention strategies.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility - goal attainment</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>Participants will be asked to report whether they attained or made progress on goals identified in the a-EMI introduction module.</description>
    </secondary_outcome>
    <number_of_arms>8</number_of_arms>
    <enrollment type="Anticipated">136</enrollment>
    <condition>Alcohol Drinking</condition>
    <condition>Cannabis Use</condition>
    <arm_group>
      <arm_group_label>Condition 1: Craving daily+PBS daily</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>EMA + Introduction Module + Craving reduction and protective behavioral strategy (PBS) messages, each delivered once daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Condition 2: Craving daily+PBS trigger</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>EMA + Introduction Module + Craving reduction messages delivered once daily and PBS trigger messages</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Condition 3: Craving trigger+PBS daily</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>EMA + Introduction Module + Craving reduction trigger messages and PBS messages delivered once daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Condition 4: Craving trigger+PBS trigger</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>EMA + Introduction Module + Craving reduction trigger and PBS trigger messages</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Condition 5: PBS daily+ PBS trigger</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>EMA + Introduction Module + PBS delivered once daily and PBS trigger messages</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Condition 6: Craving daily+Craving trigger</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>EMA + Introduction Module + Craving reduction delivered once daily and craving reduction trigger messages</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>EMA + Introduction Module + Craving reduction delivered once daily, craving reduction trigger messages, PBS delivered once daily, and PBS trigger messages</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Condition 8: No daily or trigger craving or PBS</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>EMA + Introduction Module + no other messages</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Condition 1: Craving daily+PBS daily</intervention_name>
      <description>Participants in this condition will complete ecological momentary assessment (EMA) for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction and protective behavioral strategy (PBS) messages, each delivered once daily, until the end of the six-week period.</description>
      <arm_group_label>Condition 1: Craving daily+PBS daily</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Condition 2: Craving daily+PBS trigger</intervention_name>
      <description>Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction messages delivered once daily and PBS trigger messages that will be based on responses to signal-contingent EMA questions.</description>
      <arm_group_label>Condition 2: Craving daily+PBS trigger</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Condition 3: Craving trigger+PBS daily</intervention_name>
      <description>Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction messages that will be delivered based on responses to signal-contingent EMA questions and PBS delivered once daily.</description>
      <arm_group_label>Condition 3: Craving trigger+PBS daily</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Condition 4: Craving trigger+PBS trigger</intervention_name>
      <description>Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction and PBS messages delivered based on responses to signal-contingent EMA questions.</description>
      <arm_group_label>Condition 4: Craving trigger+PBS trigger</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Condition 5: PBS daily+ PBS trigger</intervention_name>
      <description>Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive PBS messages delivered once daily and PBS trigger messages that will be based on responses to signal-contingent EMA questions.</description>
      <arm_group_label>Condition 5: PBS daily+ PBS trigger</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Condition 6: Craving daily+Craving trigger</intervention_name>
      <description>Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction messages delivered once daily and craving reduction trigger messages that will be based on responses to signal-contingent EMA questions.</description>
      <arm_group_label>Condition 6: Craving daily+Craving trigger</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger</intervention_name>
      <description>Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction and PBS messages delivered once daily and non-repetitive craving reduction and PBS trigger messages that will be based on responses to signal-contingent EMA questions.</description>
      <arm_group_label>Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Condition 8: No daily or trigger craving or PBS</intervention_name>
      <description>Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will not receive any further intervention strategies.</description>
      <arm_group_label>Condition 8: No daily or trigger craving or PBS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  resident of state of Hawai'i and island of O'ahu&#xD;
  &#xD;
            -  age 18-30 years&#xD;
  &#xD;
            -  has sought services at Kaiser Permanente Hawaii within the past year&#xD;
  &#xD;
            -  report marijuana use, heavy drinking, and simultaneous alcohol and marijuana use&#xD;
  &#xD;
            -  report confidence in ability to use protective behavioral strategies&#xD;
  &#xD;
            -  endorse at least 3 recent negative consequences from marijuana and/or alcohol&#xD;
  &#xD;
            -  own a smartphone&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • any substance use treatment within the past 3 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kristina Phillips, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kaiser Permanente Hawaii</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kristina Phillips, PhD</last_name>
      <phone>808-432-4687</phone>
      <email>kristina.t.phillips@kp.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jonathan Lai, BSN</last_name>
      <phone>808-476-1747</phone>
      <email>jonathan.ws.lai@kp.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 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 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alcohol Drinking</mesh_term>
      <mesh_term>Marijuana Use</mesh_term>
    </condition_browse>
    <!-- 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/NCT05991882
  org study id: R34DA056759
  secondary id: R34DA056759
  nct id: NCT05991882
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this treatment development project is to develop an adaptive ecological momentary
        intervention (a-EMI) for young adults using marijuana and alcohol that is grounded in
        self-regulation and social cognitive theories. To determine the most efficacious intervention
        strategies, the investigators will test variations of intervention components to identify the
        best combination. The study will take place at the Center for Integrated Health Care Research
        at Kaiser Permanente Hawaii (KPHI), located in Honolulu (island of Oahu). Following pilot
        testing with 6 participants, the study team will assess the feasibility and efficacy of
        intervention components on two primary outcomes (negative consequences and protective
        behavioral strategies [PBS]) using a fractional factorial experimental design, with
        post-intervention assessment and one- and three-month follow-ups. 136 diverse young adults
        recruited from KPHI who report current simultaneous alcohol and marijuana (SAM) use will be
        randomly assigned to one of eight groups, representing experimental conditions that include
        or do not include intervention strategies focused on craving reduction and PBS. As a result
        of this process, individual and/or combined components that lead to improved outcomes will be
        retained in a subsequent randomized controlled trial, while ineffective components will be
        eliminated.
  Up to one-third of young adults report use of marijuana or alcohol in the past month, with
        sizable numbers reporting daily marijuana use and heavy episodic drinking. Simultaneous
        alcohol and marijuana (SAM) use, defined as use of both substances at the same time or within
        a few hours of each other with overlapping effects, is common among young adults. Recent
        research has shown that SAM use leads to greater negative consequences compared to use of
        either substance alone. No current intervention addresses SAM use specifically and few
        leverage new technological methods (e.g., smartphones) or strategies (e.g., protective
        behavioral strategies [PBS]) to engage young adults.
  
        The goal of this Stage I treatment development project is to develop a fully mobile adaptive
        ecological momentary intervention (a-EMI) titled "Smartphone App For Effectively Reducing
        Risk (SAFERR)" that is grounded in self-regulation and social cognitive theories. To
        determine the most efficacious intervention strategies, the investigators will test
        variations of intervention components to identify the best combination. They will assess the
        feasibility and efficacy of intervention components on two outcomes (negative consequences
        and PBS) using a fractional factorial experimental design.
  
        The study will take place at the Center for Integrated Health Care Research at Kaiser
        Permanente Hawaii (KPHI), located in Honolulu (island of Oahu). Following pilot testing, the
        SAFERR a-EMI will be administered to 6 eligible participants. Based on the feedback, the app
        will be revised and a trial of the SAFERR intervention will begin. 136 diverse young adults
        who report current SAM use will be recruited from primary care clinics at KPHI. Eligible
        individuals will complete a baseline assessment and then be randomly assigned (by sex) to one
        of eight conditions using stratified randomization. Each condition either includes or does
        not include four different intervention strategies focused on craving reduction and PBS. All
        participants will complete signal-contingent (random prompts three times per day) and
        event-related ecological momentary assessment (EMA) for 6 weeks using a smartphone
        application (app). EMA will continue during the 4-week intervention phase. At the beginning
        of the intervention, all participants will complete an introduction module via the study app
        that includes psychoeducation, personalized feedback, and goal setting. Participants will
        then begin the a-EMI via the study app, with components delivered based on their condition
        assignment.
  
        Following completion of the intervention, participants will complete a post-intervention
        assessment and follow-up assessments at one- and three-months. The feasibility of the a-EMI
        and design will be examined by assessing: study attrition and response rates/time, module
        completion rates, acceptability (satisfaction, usability), perceived helpfulness, goal
        attainment, and implementation and intervention engagement. The efficacy of intervention
        components on negative consequences and PBS during EMA and at post-intervention and one-month
        and three-month follow-ups will be examined. In a future, larger study, the most useful
        components will be incorporated into a full intervention package and tested in a randomized
        controlled trial.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: Participants will be randomly assigned to one of eight conditions
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Participants in the factorial trial will be informed generally of the assigned condition (i.e., introduction module + no daily messages or introduction module + daily messages), but not given detailed content.
  measure: Negative consequences associated with alcohol, marijuana, and simultaneous alcohol and marijuana (SAM) use
  time frame: Through study completion, an average of 5 months
  description: Changes in negative consequences will be assessed using a measure that assesses alcohol, marijuana, and SAM use negative consequences. Items are rated dichotomously (yes/no).
  measure: Protective behavioral strategies for alcohol
  time frame: Through study completion, an average of 5 months
  description: Changes in protective behavioral strategies for alcohol will be assessed using the Protective Drinking Practices Scale (PDPS), which assesses use of protective behavioral strategies related to alcohol on a 1 (never) to 6 (always) scale.
  measure: Protective behavioral strategies for marijuana
  time frame: Through study completion, an average of 5 months
  description: Changes in protective behavioral strategies for marijuana will be assessed using the Protective Behavioral Strategies for Marijuana (PBSM) Scale, which assesses use of protective behavioral strategies related to marijuana on a 1 (never) to 6 (always) scale.
  measure: Feasibility - study attrition
  time frame: Through study completion, an average of 5 months
  description: Number of completed study phases, including six weeks of ecological momentary assessment (EMA), the 4-week a-EMI period, post-intervention assessment, and one- and three-month follow-up assessments.
  measure: Feasibility - response rate
  time frame: Week 7
  description: Number of completed prompts across 6-week EMA
  measure: Feasibility - module completion rate
  time frame: Week 7
  description: Completion of introduction module focused on psychoeducation, personalized feedback, and goal setting
  measure: Feasibility - acceptability of the intervention
  time frame: Week 7
  description: The revised Client Satisfaction Questionnaire (CSQ-8) will assess satisfaction with the intervention, perceptions of format and language of the a-EMI messages, and usability of the a-EMI (e.g., manner in which information was presented, language, question/intervention strategy comprehension, strategy delivery, timing, and study and a-EMI burden).
  measure: Feasibility - perceived helpfulness of intervention strategies
  time frame: Week 7
  description: A Feedback Measure will assess perceptions of the helpfulness of particular intervention strategies, as well as other useful strategies that could be added.
  measure: Feasibility - intervention implementation
  time frame: Week 7
  description: Intervention implementation will be examined through a short survey that will assess the ease of app use and accessibility, any challenges requesting strategies when needed, and any problems with the technology.
  measure: Feasibility - intervention engagement
  time frame: Week 7
  description: Intervention engagement will be assessed by examining participant's use of intervention strategies.
  measure: Feasibility - goal attainment
  time frame: Through study completion, an average of 5 months
  description: Participants will be asked to report whether they attained or made progress on goals identified in the a-EMI introduction module.
  arm group label: Condition 1: Craving daily+PBS daily
  arm group type: Experimental
  description: EMA + Introduction Module + Craving reduction and protective behavioral strategy (PBS) messages, each delivered once daily
  arm group label: Condition 2: Craving daily+PBS trigger
  arm group type: Experimental
  description: EMA + Introduction Module + Craving reduction messages delivered once daily and PBS trigger messages
  arm group label: Condition 3: Craving trigger+PBS daily
  arm group type: Experimental
  description: EMA + Introduction Module + Craving reduction trigger messages and PBS messages delivered once daily
  arm group label: Condition 4: Craving trigger+PBS trigger
  arm group type: Experimental
  description: EMA + Introduction Module + Craving reduction trigger and PBS trigger messages
  arm group label: Condition 5: PBS daily+ PBS trigger
  arm group type: Experimental
  description: EMA + Introduction Module + PBS delivered once daily and PBS trigger messages
  arm group label: Condition 6: Craving daily+Craving trigger
  arm group type: Experimental
  description: EMA + Introduction Module + Craving reduction delivered once daily and craving reduction trigger messages
  arm group label: Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger
  arm group type: Experimental
  description: EMA + Introduction Module + Craving reduction delivered once daily, craving reduction trigger messages, PBS delivered once daily, and PBS trigger messages
  arm group label: Condition 8: No daily or trigger craving or PBS
  arm group type: Other
  description: EMA + Introduction Module + no other messages
  intervention type: Behavioral
  intervention name: Condition 1: Craving daily+PBS daily
  description: Participants in this condition will complete ecological momentary assessment (EMA) for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction and protective behavioral strategy (PBS) messages, each delivered once daily, until the end of the six-week period.
  arm group label: Condition 1: Craving daily+PBS daily
  intervention type: Behavioral
  intervention name: Condition 2: Craving daily+PBS trigger
  description: Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction messages delivered once daily and PBS trigger messages that will be based on responses to signal-contingent EMA questions.
  arm group label: Condition 2: Craving daily+PBS trigger
  intervention type: Behavioral
  intervention name: Condition 3: Craving trigger+PBS daily
  description: Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction messages that will be delivered based on responses to signal-contingent EMA questions and PBS delivered once daily.
  arm group label: Condition 3: Craving trigger+PBS daily
  intervention type: Behavioral
  intervention name: Condition 4: Craving trigger+PBS trigger
  description: Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction and PBS messages delivered based on responses to signal-contingent EMA questions.
  arm group label: Condition 4: Craving trigger+PBS trigger
  intervention type: Behavioral
  intervention name: Condition 5: PBS daily+ PBS trigger
  description: Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive PBS messages delivered once daily and PBS trigger messages that will be based on responses to signal-contingent EMA questions.
  arm group label: Condition 5: PBS daily+ PBS trigger
  intervention type: Behavioral
  intervention name: Condition 6: Craving daily+Craving trigger
  description: Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction messages delivered once daily and craving reduction trigger messages that will be based on responses to signal-contingent EMA questions.
  arm group label: Condition 6: Craving daily+Craving trigger
  intervention type: Behavioral
  intervention name: Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger
  description: Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction and PBS messages delivered once daily and non-repetitive craving reduction and PBS trigger messages that will be based on responses to signal-contingent EMA questions.
  arm group label: Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger
  intervention type: Behavioral
  intervention name: Condition 8: No daily or trigger craving or PBS
  description: Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will not receive any further intervention strategies.
  arm group label: Condition 8: No daily or trigger craving or PBS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: No
  last name: Kristina Phillips, PhD
  role: Principal Investigator
  affiliation: Kaiser Permanente Hawaii
  last name: Kristina Phillips, PhD
  phone: 808-432-4687
  email: kristina.t.phillips@kp.org
  last name: Jonathan Lai, BSN
  phone: 808-476-1747
  email: jonathan.ws.lai@kp.org
  responsible party type: Sponsor
  mesh term: Alcohol Drinking
  mesh term: Marijuana Use