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/NCT05966831</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00234352</org_study_id>
      <nct_id>NCT05966831</nct_id>
    </id_info>
    <brief_title>Metacognitive Self Control and Job Interview Training</brief_title>
    <official_title>A Randomized Effectiveness Trial of Metacognitive Self Control and Job Interview Training</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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 study is a randomized controlled trial (RCT) that assesses the effectiveness of a&#xD;
        metacognitive self-control training intervention (MCT) in conjunction with virtual-reality&#xD;
        job interview training (VR-JIT) in a sample of formerly incarcerated individuals. The study&#xD;
        also includes an implementation evaluation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal is to conduct a randomized controlled trial (RCT) that assesses the effectiveness of&#xD;
        a metacognitive self-control training intervention (MCT) in conjunction with virtual-reality&#xD;
        job interview training (VR-JIT) in a sample of formerly incarcerated individuals, as well as&#xD;
        complete an implementation evaluation. Participants will be recruited who who: 1) have&#xD;
        previously been incarcerated (e.g., jail, prison), 2) have reentered society, 3) 18 years of&#xD;
        age or older, 4) currently are a part of the A Brighter Way program. A Brighter Way is a&#xD;
        local re-entry program in Ypsilanti, Michigan (MI) that focuses on helping formerly&#xD;
        incarcerated individuals (living in Washtenaw county) build stable and successful lives.&#xD;
        Participants will be randomly assigned to conditions where they either receive both MCT and&#xD;
        VR-JIT interventions, or where they receive an Active-Control Activity and VR-JIT&#xD;
        intervention (with an allocation ratio of 1:1). To assess the effectiveness of MCT,&#xD;
        researchers plan to compare behavioral and self-report measures of self-control pre and post&#xD;
        interventions, as well as assess employment and recidivism outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">January 10, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2024</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>Group 1 will receive two interventions: Metacognitive Self-Control Training plus Virtual Reality Job Interview Training.&#xD;
  Group 2 will receive one intervention: Virtual Reality Job Interview Training</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Self-Control Measured by Brief Self-Control Scale (BSCS)</measure>
      <time_frame>Baseline and posttest (approximately 8 weeks after baseline)</time_frame>
      <description>The measure is a Likert Scale style questionnaire. 13 items are scored from 1 (not at all) to 5 (Very much). The total score is calculated from adding all items together and higher scores indicate higher levels of self-control.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Self-Control Measured by Barratt Impulsiveness Scale</measure>
      <time_frame>Baseline and posttest (approximately 8 weeks after baseline)</time_frame>
      <description>The measure is a Likert Scale style questionnaire. 30 items are scored from 1 (Rarely/Never) to 4 (Almost Always/Always). The total score is calculated from adding all items together and range from 30 to 120; higher scores indicate higher levels of impulsiveness.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Self-Control Measured by Short Form Self-Regulation Questionnaire</measure>
      <time_frame>Baseline and posttest (approximately 8 weeks after baseline)</time_frame>
      <description>The measure is a Likert Scale style questionnaire. 31 items are scored from 1 (Strongly Disagree) to 5 (Strongly Agree). The total score is calculated from adding all items together. Higher scores indicate higher self-regulation capacity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Adult Attention Deficit/Hyperactivity Disorder (ADHD) Symptomology measured by ADHD Self-Report Scale (ASRS)</measure>
      <time_frame>Baseline and posttest (approximately 8 weeks after baseline)</time_frame>
      <description>The Adult ADHD Self-Report Scale (ASRS) is an instrument consisting of the eighteen Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV TR) criteria. Six of the eighteen questions were found to be the most predictive of symptoms consistent with ADHD. These six questions are the basis for the ASRS v1.1 Screener and are also Part A of the Symptom Checklist. Part B of the Symptom Checklist contains the remaining twelve questions. All questions utilize a Likert scale from Never, Rarely, Sometimes, Often, to Very Often.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Adult Attention Deficit/Hyperactivity Disorder (ADHD) Symptomology measured by the Structured Clinical Interview (SCID-RV) for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)</measure>
      <time_frame>Baseline and posttest (approximately 8 weeks after baseline)</time_frame>
      <description>The Structured Clinical Interview (SCID-RV) for DSM-5 for Adult Attention-Deficit/Hyperactivity Disorder measures ADHD symptomology. The module is made up of 5 major criteria with items in each criteria using a 3 point Likert scale ranging from 1 &quot;absent or False&quot; to 3 &quot;threshold or true&quot;. This module uses a dichotomous scoring method that indexes whether a symptom is present or not. Only responses of &quot;threshold or true&quot; are coded as symptom present, while responses of &quot;subthreshold&quot; or &quot;absent or false&quot; are coded as symptom absent, so each individual will have a score of symptom absent = 0, and symptom present = 1 for criteria A through E.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Employment Outcome</measure>
      <time_frame>Baseline and 9 Month Follow Up (9 Months after randomization)</time_frame>
      <description>Employment survey indicating that participants are either employed (1) or unemployed (0).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Recidivism</measure>
      <time_frame>Baseline and throughout 9 Month Follow Up (9 Months after randomization)</time_frame>
      <description>Researchers will track if a participant becomes re-incarcerated throughout the entire study. This will be marked as Yes (1) or No (0) in our database tracking.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Self-Control</condition>
    <condition>Recidivism</condition>
    <arm_group>
      <arm_group_label>Metacognitive Self-Control Training (MCT) + Virtual Reality Job Interview Training (VR-JIT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will receive the MCT intervention plus the VR-JIT intervention. We are anticipating 6-8 weeks, with 1-3 sessions per week for each intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Virtual Reality Job Interview Training (VR-JIT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will receive just the VR-JIT intervention. We are anticipating 6-8 weeks, with 1-3 sessions per week for this intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Metacognitive Self-Control Training (MCT)</intervention_name>
      <description>Metacognitive Self-Control Training (MCT) was originally developed by the Michigan Skills Project for students in middle/high school. The MCT training intervention has been updated to be suitable for adults. MCT is a lecture style intervention that encompasses 13 modules (over the course of 4 weeks) on improving self-control that is to be delivered in a community setting. Across the training, participants will learn new &quot;tools&quot; for improving self-control.</description>
      <arm_group_label>Metacognitive Self-Control Training (MCT) + Virtual Reality Job Interview Training (VR-JIT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Virtual Reality Job Interview Training (VR-JIT)</intervention_name>
      <description>VR-JIT provides trainees with an opportunity to repeatedly practice interviewing for a job at fictional company 'Wondersmart'. Prior to interviewing, trainees review self-guided e-learning materials on how to find, prepare for, succeed in, and follow-up on job interviews that includes the review of 10 job interview skills. Trainees also complete an online job application for one of 14 jobs (e.g., cashier, clerical, customer service, food services, inventory, janitorial, web developer) that informs the virtual interview experience.</description>
      <arm_group_label>Metacognitive Self-Control Training (MCT) + Virtual Reality Job Interview Training (VR-JIT)</arm_group_label>
      <arm_group_label>Virtual Reality Job Interview Training (VR-JIT)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years or older&#xD;
  &#xD;
            -  Actively enrolled in A Brighter Way Program&#xD;
  &#xD;
            -  3rd grade reading level or higher&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has uncorrected hearing or visual problem that prevents them from using the training&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <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>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Matthew Smith</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>employment</keyword>
    <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/NCT05966831
  org study id: HUM00234352
  nct id: NCT05966831
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is a randomized controlled trial (RCT) that assesses the effectiveness of a
        metacognitive self-control training intervention (MCT) in conjunction with virtual-reality
        job interview training (VR-JIT) in a sample of formerly incarcerated individuals. The study
        also includes an implementation evaluation.
  The goal is to conduct a randomized controlled trial (RCT) that assesses the effectiveness of
        a metacognitive self-control training intervention (MCT) in conjunction with virtual-reality
        job interview training (VR-JIT) in a sample of formerly incarcerated individuals, as well as
        complete an implementation evaluation. Participants will be recruited who who: 1) have
        previously been incarcerated (e.g., jail, prison), 2) have reentered society, 3) 18 years of
        age or older, 4) currently are a part of the A Brighter Way program. A Brighter Way is a
        local re-entry program in Ypsilanti, Michigan (MI) that focuses on helping formerly
        incarcerated individuals (living in Washtenaw county) build stable and successful lives.
        Participants will be randomly assigned to conditions where they either receive both MCT and
        VR-JIT interventions, or where they receive an Active-Control Activity and VR-JIT
        intervention (with an allocation ratio of 1:1). To assess the effectiveness of MCT,
        researchers plan to compare behavioral and self-report measures of self-control pre and post
        interventions, as well as assess employment and recidivism outcomes.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: Group 1 will receive two interventions: Metacognitive Self-Control Training plus Virtual Reality Job Interview Training.
  Group 2 will receive one intervention: Virtual Reality Job Interview Training
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: Change in Self-Control Measured by Brief Self-Control Scale (BSCS)
  time frame: Baseline and posttest (approximately 8 weeks after baseline)
  description: The measure is a Likert Scale style questionnaire. 13 items are scored from 1 (not at all) to 5 (Very much). The total score is calculated from adding all items together and higher scores indicate higher levels of self-control.
  measure: Change in Self-Control Measured by Barratt Impulsiveness Scale
  time frame: Baseline and posttest (approximately 8 weeks after baseline)
  description: The measure is a Likert Scale style questionnaire. 30 items are scored from 1 (Rarely/Never) to 4 (Almost Always/Always). The total score is calculated from adding all items together and range from 30 to 120; higher scores indicate higher levels of impulsiveness.
  measure: Change in Self-Control Measured by Short Form Self-Regulation Questionnaire
  time frame: Baseline and posttest (approximately 8 weeks after baseline)
  description: The measure is a Likert Scale style questionnaire. 31 items are scored from 1 (Strongly Disagree) to 5 (Strongly Agree). The total score is calculated from adding all items together. Higher scores indicate higher self-regulation capacity.
  measure: Change in Adult Attention Deficit/Hyperactivity Disorder (ADHD) Symptomology measured by ADHD Self-Report Scale (ASRS)
  time frame: Baseline and posttest (approximately 8 weeks after baseline)
  description: The Adult ADHD Self-Report Scale (ASRS) is an instrument consisting of the eighteen Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV TR) criteria. Six of the eighteen questions were found to be the most predictive of symptoms consistent with ADHD. These six questions are the basis for the ASRS v1.1 Screener and are also Part A of the Symptom Checklist. Part B of the Symptom Checklist contains the remaining twelve questions. All questions utilize a Likert scale from Never, Rarely, Sometimes, Often, to Very Often.
  measure: Change in Adult Attention Deficit/Hyperactivity Disorder (ADHD) Symptomology measured by the Structured Clinical Interview (SCID-RV) for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
  time frame: Baseline and posttest (approximately 8 weeks after baseline)
  description: The Structured Clinical Interview (SCID-RV) for DSM-5 for Adult Attention-Deficit/Hyperactivity Disorder measures ADHD symptomology. The module is made up of 5 major criteria with items in each criteria using a 3 point Likert scale ranging from 1 "absent or False" to 3 "threshold or true". This module uses a dichotomous scoring method that indexes whether a symptom is present or not. Only responses of "threshold or true" are coded as symptom present, while responses of "subthreshold" or "absent or false" are coded as symptom absent, so each individual will have a score of symptom absent = 0, and symptom present = 1 for criteria A through E.
  measure: Change in Employment Outcome
  time frame: Baseline and 9 Month Follow Up (9 Months after randomization)
  description: Employment survey indicating that participants are either employed (1) or unemployed (0).
  measure: Change in Recidivism
  time frame: Baseline and throughout 9 Month Follow Up (9 Months after randomization)
  description: Researchers will track if a participant becomes re-incarcerated throughout the entire study. This will be marked as Yes (1) or No (0) in our database tracking.
  arm group label: Metacognitive Self-Control Training (MCT) + Virtual Reality Job Interview Training (VR-JIT)
  arm group type: Experimental
  description: This group will receive the MCT intervention plus the VR-JIT intervention. We are anticipating 6-8 weeks, with 1-3 sessions per week for each intervention.
  arm group label: Virtual Reality Job Interview Training (VR-JIT)
  arm group type: Experimental
  description: This group will receive just the VR-JIT intervention. We are anticipating 6-8 weeks, with 1-3 sessions per week for this intervention.
  intervention type: Behavioral
  intervention name: Metacognitive Self-Control Training (MCT)
  description: Metacognitive Self-Control Training (MCT) was originally developed by the Michigan Skills Project for students in middle/high school. The MCT training intervention has been updated to be suitable for adults. MCT is a lecture style intervention that encompasses 13 modules (over the course of 4 weeks) on improving self-control that is to be delivered in a community setting. Across the training, participants will learn new "tools" for improving self-control.
  arm group label: Metacognitive Self-Control Training (MCT) + Virtual Reality Job Interview Training (VR-JIT)
  intervention type: Behavioral
  intervention name: Virtual Reality Job Interview Training (VR-JIT)
  description: VR-JIT provides trainees with an opportunity to repeatedly practice interviewing for a job at fictional company 'Wondersmart'. Prior to interviewing, trainees review self-guided e-learning materials on how to find, prepare for, succeed in, and follow-up on job interviews that includes the review of 10 job interview skills. Trainees also complete an online job application for one of 14 jobs (e.g., cashier, clerical, customer service, food services, inventory, janitorial, web developer) that informs the virtual interview experience.
  arm group label: Metacognitive Self-Control Training (MCT) + Virtual Reality Job Interview Training (VR-JIT)
  arm group label: Virtual Reality Job Interview Training (VR-JIT)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Matthew Smith
  investigator title: Professor
  sharing ipd: No