<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/NCT04441229</url>
  </required_header>
  <id_info>
    <org_study_id>19-00810</org_study_id>
    <nct_id>NCT04441229</nct_id>
  </id_info>
  <brief_title>Mobile Attentional Bias Modification Training in Pediatric MS</brief_title>
  <official_title>A Prospective, Observational Study of Mobile Attentional Bias Modification Training (ABMT) in the Pediatric Multiple Sclerosis (MS) Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
      This study will examine the feasibility of using a mobile ABMT application as a treatment&#xD;
      modality in the Pediatric Multiple Sclerosis population. Participants will be asked to&#xD;
      undergo one hour-long baseline evaluation, followed by at-home ABMT application sessions.&#xD;
      Subjects will complete online REDCap or MyCap surveys weekly and at the end of the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">March 26, 2021</completion_date>
  <primary_completion_date type="Actual">March 25, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of &quot;compliant&quot; participants</measure>
    <time_frame>30 days</time_frame>
    <description>Individuals will be categorized as &quot;compliant&quot; if they interact with the mobile ABMT a minimum of 3 times per week for a minimum of three of the four weeks across the study period of 30 days. We will consider reaching 50% of compliant participants to indicate that the intervention is feasible for continued study. Descriptive analyses will be completed to identify any trends in predicting those participants who are most likely to be compliant (ie. age, gender, baseline function).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preliminary efficacy composite score</measure>
    <time_frame>3 months</time_frame>
    <description>Investigators convert performance at baseline and study end across study measures SCARED P/C,CDI-II, MASC-2, BDI-II, BAI, and PANAS to scaled age normative scores. Differences in scaled scores, indicating change following intervention, will be calculated for each compliant participant (defined as above) and averaged for group metrics. Descriptive analyses will be completed to identify any trends in predicting those participants who are most likely to have improvement in anxiety and mood at study end (ie., age, gender, baseline function) as well as corresponding degree of use of the mobile ABMT with magnitude of benefit.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Pediatric Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients age 12-24 diagnosed with pediatric-onset Multiple Sclerosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ABMT mobile application</intervention_name>
    <description>After consent/assent, participants will complete 1 hour-long, in-person or remote, baseline study visit at the Multiple Sclerosis Comprehensive Care Center. During this visit, participants will complete baseline study surveys and a brief computerized attention bias assessment and be trained on the use of the ABMT mobile application. Participants will then complete at-home game play 4 days a week, for 30 days, using an iOS mobile device, approximately 10-15 minutes each day. Subjects will complete weekly online study surveys via REDCap or MyCap (Mobile REDCap Application). At the conclusion of participation, participants will complete online end of study surveys via REDCap or MyCap.&#xD;
Parents of participants will complete surveys at the baseline visit, followed by online surveys at Week 2 and at the end of study. For participants who are 18 years old or older, parental participation will not be required.</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 12-24 years&#xD;
&#xD;
          -  Confirmed Diagnosis of Multiple Sclerosis with onset &lt; 17 years and 11 months (defined&#xD;
             by the 2013 International Pediatric MS Study Group (IPMSSG) criteria (Krupp, Tardieu,&#xD;
             Amato, Banwell, Chitnis, Dale, Ghezzi, Hintzen, Kornberg, Pohl, Rostasy, Tenembaum,&#xD;
             Wassmer, &amp; Sclerosis, 2013) and the 2010 McDonald criteria (Polman et al., 2011).)&#xD;
&#xD;
          -  Followed at NYU Multiple Sclerosis Comprehensive Care Center&#xD;
&#xD;
          -  Access to a mobile device with iOS (devices will be provided to subjects if this&#xD;
             criteria is not met, see section 4.4)&#xD;
&#xD;
          -  Active or concurrently enrolled in the ongoing US Network of Pediatric MS Centers&#xD;
             Study Consortium&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous report of an IQ &lt; 70&#xD;
&#xD;
          -  Wide-Range Achievement Test-Fourth Edition (Wilkerson, 2006) Reading Subtest standard&#xD;
             score &lt;85&#xD;
&#xD;
          -  Non-English speaking, learned English in the past three years, or learned English&#xD;
             after the age of 12 years&#xD;
&#xD;
          -  Not willing to comply with all study procedures&#xD;
&#xD;
          -  Insufficient visual and motor ability to operate the intervention and assessments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leigh Charvet</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2022</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>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: leigh.charvet@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
    <ipd_access_criteria>Requests should be directed to leigh.charvet@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04441229
org study id: 19-00810
nct id: NCT04441229
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will examine the feasibility of using a mobile ABMT application as a treatment
      modality in the Pediatric Multiple Sclerosis population. Participants will be asked to
      undergo one hour-long baseline evaluation, followed by at-home ABMT application sessions.
      Subjects will complete online REDCap or MyCap surveys weekly and at the end of the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of "compliant" participants
time frame: 30 days
description: Individuals will be categorized as "compliant" if they interact with the mobile ABMT a minimum of 3 times per week for a minimum of three of the four weeks across the study period of 30 days. We will consider reaching 50% of compliant participants to indicate that the intervention is feasible for continued study. Descriptive analyses will be completed to identify any trends in predicting those participants who are most likely to be compliant (ie. age, gender, baseline function).
measure: Preliminary efficacy composite score
time frame: 3 months
description: Investigators convert performance at baseline and study end across study measures SCARED P/C,CDI-II, MASC-2, BDI-II, BAI, and PANAS to scaled age normative scores. Differences in scaled scores, indicating change following intervention, will be calculated for each compliant participant (defined as above) and averaged for group metrics. Descriptive analyses will be completed to identify any trends in predicting those participants who are most likely to have improvement in anxiety and mood at study end (ie., age, gender, baseline function) as well as corresponding degree of use of the mobile ABMT with magnitude of benefit.
arm group label: Treatment Group
arm group type: Experimental
description: Patients age 12-24 diagnosed with pediatric-onset Multiple Sclerosis
intervention type: Behavioral
intervention name: ABMT mobile application
description: After consent/assent, participants will complete 1 hour-long, in-person or remote, baseline study visit at the Multiple Sclerosis Comprehensive Care Center. During this visit, participants will complete baseline study surveys and a brief computerized attention bias assessment and be trained on the use of the ABMT mobile application. Participants will then complete at-home game play 4 days a week, for 30 days, using an iOS mobile device, approximately 10-15 minutes each day. Subjects will complete weekly online study surveys via REDCap or MyCap (Mobile REDCap Application). At the conclusion of participation, participants will complete online end of study surveys via REDCap or MyCap.
Parents of participants will complete surveys at the baseline visit, followed by online surveys at Week 2 and at the end of study. For participants who are 18 years old or older, parental participation will not be required.
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 12 Years
maximum age: 24 Years
healthy volunteers: No
last name: Leigh Charvet
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Yes
ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: leigh.charvet@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
ipd access criteria: Requests should be directed to leigh.charvet@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.