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/NCT06038799</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY23040076</org_study_id>
      <nct_id>NCT06038799</nct_id>
    </id_info>
    <brief_title>Caregiver Skills Training: Comparing Clinician Training Methods</brief_title>
    <acronym>CST</acronym>
    <official_title>Caregiver Skills Training: Comparing the Effectiveness of Training Clinicians Via Telehealth and In-Person Training</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pittsburgh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Autism Speaks</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Pittsburgh</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>
        Caregiver Skills Training (CST) is an evidence-based intervention for parents of young&#xD;
        children with developmental disabilities that was developed through a collaboration between&#xD;
        Autism Speaks and the World Health Organization. The intervention is typically offered by&#xD;
        Facilitators who are trained and supervised by CST Master Trainers. This study seeks to use a&#xD;
        remote training model to compare two training and supervision processes. One group, comprised&#xD;
        of facilitators from rural settings, will be trained and supervised by two master trainers&#xD;
        from the University of Pittsburgh using a remote training model. A second group, comprised of&#xD;
        facilitators from an agency serving primarily low-income households and located near&#xD;
        Pittsburgh, will be trained and supervised in a face-to-face manner. Both groups will&#xD;
        initially receive ten 90-minute training sessions over a 2-month period and will subsequently&#xD;
        receive 1 hour per week of supervision while conducting their first 12-session CST group.&#xD;
        Outcome measures will include assessment of change in caregiver stress and didactic skills as&#xD;
        well as improvement in each child's communication/social skills, functional skills, and&#xD;
        overall behavior.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There are two aspects to this study: First, the investigators will compare two training and&#xD;
        supervision processes. One group, comprised of facilitators from rural settings, will be&#xD;
        trained and supervised by two master trainers from the University of Pittsburgh Medical&#xD;
        Center (UPMC) Center for Autism and Developmental Disorders (CADD). A second group, comprised&#xD;
        of facilitators from an agency serving primarily low-income households and located near&#xD;
        Pittsburgh, PA, will be trained and supervised in a face-to-face manner. Both groups will&#xD;
        receive 15 hours of training spread over the course of 2-3 months (in summer 2023). The focus&#xD;
        of these sessions will be to introduce and train staff on the CST model, ensure their&#xD;
        understanding of the curriculum, and to help them gain proficiency in administration. During&#xD;
        the training phase, both groups will practice administration of activities and will be&#xD;
        provided feedback. The master trainers will also assist the newly trained facilitators in&#xD;
        navigating recruitment and organization of their first CST groups. Upon initiation of the CST&#xD;
        groups, facilitators will receive 1 hour of supervision per week, either in person or via&#xD;
        TEAMS. Supervision will extend over the 9 group sessions and 3 home visits per family (fall&#xD;
        2023). These supervision sessions will allow the facilitators to ask questions, obtain&#xD;
        feedback, and troubleshoot any challenges. The investigators will also collect pre and post&#xD;
        measures (baseline and week 12) from the parents participating in the CST groups to determine&#xD;
        if the type of training provided to the facilitators (face-to-face versus remote) impacted&#xD;
        parent progress.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The investigators will be comparing two types of training/supervision models. One will be provided remotely and one will be provided face-to-face.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Care Provider)</masking>
      <masking_description>Parents that receive Caregiver Skills Training will be unaware of whether their group leaders were trained/supervised remotely or face-to-face.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change from week 1 (baseline) to week 12 on the Caregivers Skills and Knowledge Measure</measure>
      <time_frame>Week 1 (baseline) versus week 12 (final visit)</time_frame>
      <description>eEvaluates change in caregiver skills and knowledge related to session content as well as caregiver confidence. There are 28 skills questions (scored on a scale of 1-5) with a score range fomr 28-140 (with higher scores indicating greater skills). The Confidence scale consists of 9 items (scored 1-5) with scores ranging from 9-45. Higher scores indicate greater confidence.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from week 1 (baseline) to week 12 on the Parenting Stress Index.</measure>
      <time_frame>Week 1 (baseline) versus week 12 (final visit)</time_frame>
      <description>To assess parental distress, parent-child dysfunctional interaction, and child challenges. There are 36 items and 3 subscales (12 items per subscale). Subscales include Parent Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. There is also a Total Stress Score. Each item is scored on a 1-5 scale. Range for each subscale is 12-60 points; Total Score is 36-180 points. Scores are converted to percentiles. Percentiles of 15-80 are &quot;typical stress;&quot; 81-89 are &quot;high stress;&quot; and &gt;89 are &quot;clinically significant stress.&quot; Higher percentiles indicate higher levels of stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from week 1 (baseline) to week 12 on the Vineland Adaptive Behavior Scales (VABS)</measure>
      <time_frame>Week 1 (baseline) versus week 12 (final visit)</time_frame>
      <description>To assess adaptive skills with regard to communication, socialization, daily living skills, and motor skills. Raw scores are converted to standard scores (range 20-140). The mean standard score is 100 with a standard deviation of 15. The higher the standard score, the better the adaptive behavior skills.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from week 1 (baseline) to week 12 on the Social Communication Checklist (SCC)</measure>
      <time_frame>Week 1 (baseline) versus week 12 (final visit)</time_frame>
      <description>To assess social communication abilities, specifically social engagement (15 items), expressive language form (15 items), expressive language function (15 items), receptive language (8 items) imitation (6 items, and pla (11 items). Items are scored on a 3-point scale (&quot;usually,&quot; = 3 points; &quot;sometimes,&quot; = 2 points; or &quot;rarely&quot; = 1 point). The range for all 70 items is 70-210 points. The higher the score, the greater the child's abilities.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Week 12 score on the Caregiver Diary</measure>
      <time_frame>Week 1 (baseline) versus week 12 (final visit)</time_frame>
      <description>To assess the extent to which caregivers are using the strategies they learned. Four questions address caregiver adherence and 2 address caregiver competence. Each is rated on a 1 to 5 scale (range 6 to 30 points) with higher scores indicating greater use of strategies.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">35</enrollment>
    <condition>Remote Staff Training</condition>
    <condition>Face to Face Staff Training</condition>
    <arm_group>
      <arm_group_label>Remote staff training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Staff will receive 15 hours of remote training followed by 12 weeks of remote supervision (one hour per week).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Face to face staff training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Staff will receive 15 hours of face to face training followed by 12 weeks of face to face supervision (one hour per week).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Caregiver Skills Training (CST)</intervention_name>
      <description>The investigators are comparing the relative efficacy of CST between a CST group led by clinicians trained and supervised remotely versus a group led by clinicians trained an supervised face-to-face.</description>
      <arm_group_label>Face to face staff training</arm_group_label>
      <arm_group_label>Remote staff training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Parents who&#xD;
  &#xD;
            -  Have a child ages 2-9 with a developmental disability and/or autism&#xD;
  &#xD;
            -  Able to be served by one of the three UPMC sites&#xD;
  &#xD;
            -  Able to attend 12 sessions. Group sessions are at the clinic site and the individual&#xD;
               sessions may be done virtually or in person.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Parent()s does not speak / understand English. Given the nature of this study, we are&#xD;
               unable to provide translation services.&#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>
    <overall_official>
      <last_name>Benjamin Handen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pittsburgh</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Benjamin Handen</last_name>
      <phone>14122355452</phone>
      <email>handenbl@upmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Charmaine Stillano</last_name>
      <phone>14122255174</phone>
      <email>StillanoC@upmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UPMC Altoona</name>
        <address>
          <city>Altoona</city>
          <state>Pennsylvania</state>
          <zip>16601</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shannon Tronzo</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>UPMC Mon Yough</name>
        <address>
          <city>McKeesport</city>
          <state>Pennsylvania</state>
          <zip>15132</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kirsten Yaggi</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <results_reference>
      <citation>Ludwig NN, Suskauer SJ, Rodgin S, Chen J, Borda A, Jones K, Lahey S, Slomine BS. Outcome Measurement in Children With a History of Disorders of Consciousness After Severe Brain Injury: Telephone Administration of the Vineland Adaptive Behavior Scales, Third Edition, and Glasgow Outcome Scale-Extended Pediatric Revision. Pediatr Crit Care Med. 2023 Feb 1;24(2):e76-e83. doi: 10.1097/PCC.0000000000003121. Epub 2022 Dec 16.</citation>
      <PMID>36661427</PMID>
    </results_reference>
    <results_reference>
      <citation>Holly LE, Fenley AR, Kritikos TK, Merson RA, Abidin RR, Langer DA. Evidence-Base Update for Parenting Stress Measures in Clinical Samples. J Clin Child Adolesc Psychol. 2019 Sep-Oct;48(5):685-705. doi: 10.1080/15374416.2019.1639515. Epub 2019 Aug 8.</citation>
      <PMID>31393178</PMID>
    </results_reference>
    <results_reference>
      <citation>Wainer AL, Berger NI, Ingersoll BR. Brief Report: The Preliminary Psychometric Properties of the Social Communication Checklist. J Autism Dev Disord. 2017 Apr;47(4):1231-1238. doi: 10.1007/s10803-016-3026-8.</citation>
      <PMID>28105548</PMID>
    </results_reference>
    <results_reference>
      <citation>Sengupta K, Shah H, Ghosh S, Sanghvi D, Mahadik S, Dani A, Deshmukh O, Pacione L, Dixon P, Salomone E; WHO-CST team; Servili C. World Health Organisation-Caregiver Skills Training (WHO-CST) Program: Feasibility of Delivery by Non-Specialist Providers in Real-world Urban Settings in India. J Autism Dev Disord. 2023 Apr;53(4):1444-1461. doi: 10.1007/s10803-021-05367-0. Epub 2021 Dec 1.</citation>
      <PMID>34853959</PMID>
    </results_reference>
    <results_reference>
      <citation>Kasari C, Lawton K, Shih W, Barker TV, Landa R, Lord C, Orlich F, King B, Wetherby A, Senturk D. Caregiver-mediated intervention for low-resourced preschoolers with autism: an RCT. Pediatrics. 2014 Jul;134(1):e72-9. doi: 10.1542/peds.2013-3229.</citation>
      <PMID>24958585</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
      <investigator_full_name>Benjamin L Handen, PhD, BCBA-D</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Caregiver skills training</keyword>
    <keyword>Staff training</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The investigators will share the study protocol, consent, analysis plan and results upon request by qualified researchers/professionals.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>The study protocol, consent form, and statistical analysis plan are available now (as of 9/8/23).The investigators hope to complete the data analysis by late spring 2024 (within 1 year of study completion) and will make a CSR available at that time.</ipd_time_frame>
      <ipd_access_criteria>Interested investigators should contact the PI directly, who will review requests.</ipd_access_criteria>
    </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/NCT06038799
  org study id: STUDY23040076
  nct id: NCT06038799
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Caregiver Skills Training (CST) is an evidence-based intervention for parents of young
        children with developmental disabilities that was developed through a collaboration between
        Autism Speaks and the World Health Organization. The intervention is typically offered by
        Facilitators who are trained and supervised by CST Master Trainers. This study seeks to use a
        remote training model to compare two training and supervision processes. One group, comprised
        of facilitators from rural settings, will be trained and supervised by two master trainers
        from the University of Pittsburgh using a remote training model. A second group, comprised of
        facilitators from an agency serving primarily low-income households and located near
        Pittsburgh, will be trained and supervised in a face-to-face manner. Both groups will
        initially receive ten 90-minute training sessions over a 2-month period and will subsequently
        receive 1 hour per week of supervision while conducting their first 12-session CST group.
        Outcome measures will include assessment of change in caregiver stress and didactic skills as
        well as improvement in each child's communication/social skills, functional skills, and
        overall behavior.
  There are two aspects to this study: First, the investigators will compare two training and
        supervision processes. One group, comprised of facilitators from rural settings, will be
        trained and supervised by two master trainers from the University of Pittsburgh Medical
        Center (UPMC) Center for Autism and Developmental Disorders (CADD). A second group, comprised
        of facilitators from an agency serving primarily low-income households and located near
        Pittsburgh, PA, will be trained and supervised in a face-to-face manner. Both groups will
        receive 15 hours of training spread over the course of 2-3 months (in summer 2023). The focus
        of these sessions will be to introduce and train staff on the CST model, ensure their
        understanding of the curriculum, and to help them gain proficiency in administration. During
        the training phase, both groups will practice administration of activities and will be
        provided feedback. The master trainers will also assist the newly trained facilitators in
        navigating recruitment and organization of their first CST groups. Upon initiation of the CST
        groups, facilitators will receive 1 hour of supervision per week, either in person or via
        TEAMS. Supervision will extend over the 9 group sessions and 3 home visits per family (fall
        2023). These supervision sessions will allow the facilitators to ask questions, obtain
        feedback, and troubleshoot any challenges. The investigators will also collect pre and post
        measures (baseline and week 12) from the parents participating in the CST groups to determine
        if the type of training provided to the facilitators (face-to-face versus remote) impacted
        parent progress.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: The investigators will be comparing two types of training/supervision models. One will be provided remotely and one will be provided face-to-face.
  primary purpose: Treatment
  masking: Single (Care Provider)
  masking description: Parents that receive Caregiver Skills Training will be unaware of whether their group leaders were trained/supervised remotely or face-to-face.
  measure: Change from week 1 (baseline) to week 12 on the Caregivers Skills and Knowledge Measure
  time frame: Week 1 (baseline) versus week 12 (final visit)
  description: eEvaluates change in caregiver skills and knowledge related to session content as well as caregiver confidence. There are 28 skills questions (scored on a scale of 1-5) with a score range fomr 28-140 (with higher scores indicating greater skills). The Confidence scale consists of 9 items (scored 1-5) with scores ranging from 9-45. Higher scores indicate greater confidence.
  measure: Change from week 1 (baseline) to week 12 on the Parenting Stress Index.
  time frame: Week 1 (baseline) versus week 12 (final visit)
  description: To assess parental distress, parent-child dysfunctional interaction, and child challenges. There are 36 items and 3 subscales (12 items per subscale). Subscales include Parent Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. There is also a Total Stress Score. Each item is scored on a 1-5 scale. Range for each subscale is 12-60 points; Total Score is 36-180 points. Scores are converted to percentiles. Percentiles of 15-80 are "typical stress;" 81-89 are "high stress;" and >89 are "clinically significant stress." Higher percentiles indicate higher levels of stress.
  measure: Change from week 1 (baseline) to week 12 on the Vineland Adaptive Behavior Scales (VABS)
  time frame: Week 1 (baseline) versus week 12 (final visit)
  description: To assess adaptive skills with regard to communication, socialization, daily living skills, and motor skills. Raw scores are converted to standard scores (range 20-140). The mean standard score is 100 with a standard deviation of 15. The higher the standard score, the better the adaptive behavior skills.
  measure: Change from week 1 (baseline) to week 12 on the Social Communication Checklist (SCC)
  time frame: Week 1 (baseline) versus week 12 (final visit)
  description: To assess social communication abilities, specifically social engagement (15 items), expressive language form (15 items), expressive language function (15 items), receptive language (8 items) imitation (6 items, and pla (11 items). Items are scored on a 3-point scale ("usually," = 3 points; "sometimes," = 2 points; or "rarely" = 1 point). The range for all 70 items is 70-210 points. The higher the score, the greater the child's abilities.
  measure: Week 12 score on the Caregiver Diary
  time frame: Week 1 (baseline) versus week 12 (final visit)
  description: To assess the extent to which caregivers are using the strategies they learned. Four questions address caregiver adherence and 2 address caregiver competence. Each is rated on a 1 to 5 scale (range 6 to 30 points) with higher scores indicating greater use of strategies.
  arm group label: Remote staff training
  arm group type: Active Comparator
  description: Staff will receive 15 hours of remote training followed by 12 weeks of remote supervision (one hour per week).
  arm group label: Face to face staff training
  arm group type: Active Comparator
  description: Staff will receive 15 hours of face to face training followed by 12 weeks of face to face supervision (one hour per week).
  intervention type: Behavioral
  intervention name: Caregiver Skills Training (CST)
  description: The investigators are comparing the relative efficacy of CST between a CST group led by clinicians trained and supervised remotely versus a group led by clinicians trained an supervised face-to-face.
  arm group label: Face to face staff training
  arm group label: Remote staff training
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Benjamin Handen, PhD
  role: Principal Investigator
  affiliation: University of Pittsburgh
  last name: Benjamin Handen
  phone: 14122355452
  email: handenbl@upmc.edu
  last name: Charmaine Stillano
  phone: 14122255174
  email: StillanoC@upmc.edu
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  citation: Ludwig NN, Suskauer SJ, Rodgin S, Chen J, Borda A, Jones K, Lahey S, Slomine BS. Outcome Measurement in Children With a History of Disorders of Consciousness After Severe Brain Injury: Telephone Administration of the Vineland Adaptive Behavior Scales, Third Edition, and Glasgow Outcome Scale-Extended Pediatric Revision. Pediatr Crit Care Med. 2023 Feb 1;24(2):e76-e83. doi: 10.1097/PCC.0000000000003121. Epub 2022 Dec 16.
  PMID: 36661427
  citation: Holly LE, Fenley AR, Kritikos TK, Merson RA, Abidin RR, Langer DA. Evidence-Base Update for Parenting Stress Measures in Clinical Samples. J Clin Child Adolesc Psychol. 2019 Sep-Oct;48(5):685-705. doi: 10.1080/15374416.2019.1639515. Epub 2019 Aug 8.
  PMID: 31393178
  citation: Wainer AL, Berger NI, Ingersoll BR. Brief Report: The Preliminary Psychometric Properties of the Social Communication Checklist. J Autism Dev Disord. 2017 Apr;47(4):1231-1238. doi: 10.1007/s10803-016-3026-8.
  PMID: 28105548
  citation: Sengupta K, Shah H, Ghosh S, Sanghvi D, Mahadik S, Dani A, Deshmukh O, Pacione L, Dixon P, Salomone E; WHO-CST team; Servili C. World Health Organisation-Caregiver Skills Training (WHO-CST) Program: Feasibility of Delivery by Non-Specialist Providers in Real-world Urban Settings in India. J Autism Dev Disord. 2023 Apr;53(4):1444-1461. doi: 10.1007/s10803-021-05367-0. Epub 2021 Dec 1.
  PMID: 34853959
  citation: Kasari C, Lawton K, Shih W, Barker TV, Landa R, Lord C, Orlich F, King B, Wetherby A, Senturk D. Caregiver-mediated intervention for low-resourced preschoolers with autism: an RCT. Pediatrics. 2014 Jul;134(1):e72-9. doi: 10.1542/peds.2013-3229.
  PMID: 24958585
  responsible party type: Principal Investigator
  investigator affiliation: University of Pittsburgh
  investigator full name: Benjamin L Handen, PhD, BCBA-D
  investigator title: Professor
  sharing ipd: Yes
  ipd description: The investigators will share the study protocol, consent, analysis plan and results upon request by qualified researchers/professionals.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: The study protocol, consent form, and statistical analysis plan are available now (as of 9/8/23).The investigators hope to complete the data analysis by late spring 2024 (within 1 year of study completion) and will make a CSR available at that time.
  ipd access criteria: Interested investigators should contact the PI directly, who will review requests.