<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/NCT04408027</url>
  </required_header>
  <id_info>
    <org_study_id>REB1000070362</org_study_id>
    <nct_id>NCT04408027</nct_id>
  </id_info>
  <brief_title>Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions</brief_title>
  <official_title>Mental Health Support for SickKids Children and Families During COVID-19 Using Established eHealth Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</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>
      Coronavirus disease 2019 (COVID-19) and associated emergency measures (EM) have dramatically&#xD;
      impacted the lives of children/adolescents (children) and families. The closure of schools,&#xD;
      social and recreational activities, and modifications to work environments has led to&#xD;
      significant changes in the way children and families are working, living and socializing.&#xD;
      Although the impact on the mental health of children and families has not been well&#xD;
      researched, it is anticipated that already stressed children and families with pre-COVID-19&#xD;
      mental health challenges are at significant risk for deterioration in their mental health. As&#xD;
      such, the implementation, and evaluation (specifically: feasibility, acceptability and&#xD;
      barriers) of virtual-care interventions to alleviate child and family anxiety and enhance&#xD;
      family functioning are critical. Virtual-care also optimizes health equity initiatives in&#xD;
      reducing social, economic and environmental barriers to services that can improve or maintain&#xD;
      mental health (WHO, 2017; MOHLTC, 2018).&#xD;
&#xD;
      The current study will evaluate an adapted virtual-care cognitive behavioural therapy (CBT)&#xD;
      program for children with anxiety (VC-CBT). CBT has a strong evidence-base in treating&#xD;
      children with anxiety disorders (Higa-McMillan, Francis, Rith-Najarian, and Chorpita, 2016;&#xD;
      Seligman and Ollendick, 2011), with increasing evidence supporting the efficacy of&#xD;
      virtual-care CBT for childhood anxiety disorders (Carpenter, Pincus, Furr, and Comer, 2018;&#xD;
      Slone, Reese, and McClellan, 2012). This study aims to evaluate the feasibility,&#xD;
      participation barriers related to social determinants of health (SDH) and acceptability of&#xD;
      this virtual-care intervention in addressing mental health challenges associated with the&#xD;
      COVID-19 pandemic and ensuing EM in the immediate time-period. Early evaluation of this&#xD;
      virtual-care intervention will enable future scale-up of this intervention during the&#xD;
      post-pandemic recovery time-period and during subsequent COVID-19 waves, if necessary.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design: This is a pragmatic prospective pre-post feasibility study to assess whether&#xD;
      virtual-care delivery of mental health interventions are acceptable and feasible with regard&#xD;
      to recruitment and retention, participation barriers (inclusive of SDH barriers), child and&#xD;
      parent acceptability, and adherence. Targeted symptoms of the intervention (e.g., child&#xD;
      anxiety) will be evaluated as secondary outcomes to gather preliminary data on efficacy.&#xD;
&#xD;
      Estimated Sample Size: In this first feasibility phase, participants will include children&#xD;
      referred for treatment to Psychiatry. For the purpose of this pragmatic trial, we aim to&#xD;
      recruit 20 participants for this intervention. According to Hertzog, a sample size of 20&#xD;
      participants is adequate for pilot studies to examine intervention feasibility and to develop&#xD;
      estimates of variance to compute power for larger studies (Hertzog, 2008).&#xD;
&#xD;
      Data Analyses: Data for demographic variables will be summarized using counts, percentages,&#xD;
      measures of central tendency (mean, median, and mode) and measures of sample variation&#xD;
      (standard deviation, range). Parametric statistics (mean, standard deviation) will be used&#xD;
      for interval and ratio data. To assess the feasibility and acceptability of this&#xD;
      intervention, results will include analyses of recruitment, social determinant barriers and&#xD;
      adherence rates and responses to satisfaction/evaluation and alliance scales. Pre-post&#xD;
      analysis will also include comparing mean changes in COVID specific distress, and&#xD;
      intervention specific comparisons of child anxiety.&#xD;
&#xD;
      Knowledge Translation: Our integrated Knowledge-to-action (iKTA) approach has involved&#xD;
      family, clinician and scientist engagement from the outset and will continue to do so.&#xD;
      Participants will receive updates through e-newsletters and information through email.&#xD;
      Knowledge gained will be presented at conferences and publications to further the impact of&#xD;
      generating future hypothesis-driven research and funding support.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">January 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2023</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>
    <intervention_model_description>The current study will leverage an adapted virtual-care cognitive behavioural therapy program for children with anxiety (VC-CBT). The VC-CBT protocol will involve 12 sessions (of one hour in duration) delivered by a CBT therapist using PHIPA (Personal Health Information Protection Act) compliant Zoom. An initial session will review therapy goals and psychoeducation about anxiety. Sessions 2 and 3 will focus on feeling identification and will introduce relaxation strategies. Sessions 4 and 5 will introduce cognitive distortions and restructuring strategies. Sessions 6 and 7 will introduce exposure tasks. Sessions 8 to 11 will involve practicing cognitive restructuring skills and completing exposures. The final session will review relapse prevention. Parents will participate in the first and last sessions, as well as join at the end of each session for a brief review of the skills learned during the session.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participation Barriers</measure>
    <time_frame>The Social Determinants of Health Questionnaire will be administered at baseline only, for each participant (approximately one week prior to the first of twelve sessions in the intervention).</time_frame>
    <description>Participation barriers related to Social Determinants of Health (SDH) will be captured to assess intervention feasibility. Participation barriers will be captured using the Social Determinants of Health Questionnaire (unpublished).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Eligible Participants</measure>
    <time_frame>The number of participants that were eligible for the study will be captured through study completion, estimated at approximately 1 year.</time_frame>
    <description>Number of participants that were eligible for the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Approached</measure>
    <time_frame>The number of participants that were approached for the study will be captured through study completion, estimated at approximately 1 year.</time_frame>
    <description>Number of participants that were approached for the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Consented</measure>
    <time_frame>The number of participants that were consented for the study will be captured through study completion, estimated at approximately 1 year.</time_frame>
    <description>Number of participants consented for the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rates of Refusal</measure>
    <time_frame>The rates of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.</time_frame>
    <description>Rates of refusal for participation in the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons for Refusal</measure>
    <time_frame>The reasons of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.</time_frame>
    <description>Reasons for refusal for participation in the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Sessions Completed in Total</measure>
    <time_frame>The average number of sessions completed in total, for each participant, will be assessed through study completion, estimated at approximately 1 year.</time_frame>
    <description>The average number of sessions completed in total will be captured to evaluate intervention adherence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence Index</measure>
    <time_frame>The adherence index, for each participant, will be assessed through study completion, estimated at approximately 1 year.</time_frame>
    <description>The adherence index (calculated using the formula: sessions completed/total sessions scheduled [sum of sessions attended, rescheduled, no-showed and cancelled]) will be used to evaluate intervention adherence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of time (in weeks) to complete the intervention</measure>
    <time_frame>The amount of time (in weeks) to complete the intervention, for each participant, will be assessed through study completion, estimated at approximately 1 year.</time_frame>
    <description>The amount of time (in weeks) to complete the intervention will be captured to evaluate intervention implementation experience.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Acceptability</measure>
    <time_frame>The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).</time_frame>
    <description>The measure that will be used to assess the primary outcome of intervention acceptability is the Virtual Care Satisfaction Survey (Romanchych, unpublished).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant Satisfaction</measure>
    <time_frame>The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).</time_frame>
    <description>The measure that will be used to assess participant satisfaction is the Virtual Care Satisfaction Survey (Romanchych, unpublished).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Working Alliance Inventory after First Intervention Session</measure>
    <time_frame>The Working Alliance Inventory will be administered within approximately one week after completion of the first intervention session (estimated to occur approximately 1 to 2 weeks after initiation of the study).</time_frame>
    <description>The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy &amp; Kokotovic, 1989).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Working Alliance Inventory after Sixth Intervention Session</measure>
    <time_frame>The Working Alliance Inventory will be administered within approximately one week after completion of the sixth intervention session (estimated to occur approximately 6 to 8 weeks after initiation of the study).</time_frame>
    <description>The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy &amp; Kokotovic, 1989).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Working Alliance Inventory after Final Intervention Session</measure>
    <time_frame>The Working Alliance Inventory will be administered within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).</time_frame>
    <description>The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy &amp; Kokotovic, 1989).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Family Impact During a Pandemic at Baseline</measure>
    <time_frame>CRISIS (parent/caregiver and youth forms) will be completed virtually by children and parents at baseline (approximately one week prior to the first of twelve sessions in the intervention).</time_frame>
    <description>Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Baseline Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Impact During a Pandemic after Final Intervention Session</measure>
    <time_frame>CRISIS forms will be completed virtually by children and parents, within approximately one week of completion of the twelfth (final) intervention session (approximately 12 to 16 weeks after initiation of the study).</time_frame>
    <description>Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Follow-Up Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of Virtual-Care CBT Intervention</measure>
    <time_frame>The SCARED questionnaire will be completed at both baseline and within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after study initiation).</time_frame>
    <description>To evaluate the efficacy of the virtual-care CBT intervention, change in child anxiety will be measured using child and parent-report Screen for Child Anxiety Related Disorders (SCARED; Birmaher et al., 1997). The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. In addition, it assesses symptoms related to school phobia. A total score of 25 of higher on the SCARED measure may indicate the presence of an anxiety disorder. Scores higher than 30 are more specific.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician Virtual Care Experience</measure>
    <time_frame>The Clinician Virtual Care Survey will be completed virtually by clinicians at both SickKids and CCMH at baseline.</time_frame>
    <description>In order to evaluate the experience of clinicians (at The Hospital for Sick Children (SickKids) and the Centre for Community Mental Health (CCMH)) using virtual-care platforms during the work from home shift due to COVID-19 and to identify any challenges they may be facing, a Clinician Virtual Care Experience Survey (Romanchych, unpublished) will be administered.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Anxiety Disorder of Childhood or Adolescence</condition>
  <arm_group>
    <arm_group_label>Virtual-Care Cognitive Behavioural Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual-Care Cognitive Behavioural Therapy</intervention_name>
    <description>The feasibility, participation barriers, and acceptability of the intervention, virtual-care cognitive behavioural therapy (VC-CBT), will be evaluated for children with anxiety. The VC-CBT protocol will involve 12 sessions (of one hour in duration) delivered by a CBT therapist using PHIPA (Personal Health Information Protection Act) compliant Zoom. An initial session will review therapy goals and psychoeducation about anxiety. Sessions 2 and 3 will focus on feeling identification and will introduce relaxation strategies. Sessions 4 and 5 will introduce cognitive distortions and restructuring strategies. Sessions 6 and 7 will introduce exposure tasks. Sessions 8 to 11 will involve practicing cognitive restructuring skills and completing exposures. The final session will review relapse prevention. Parents will participate in the first and last sessions, as well as join at the end of each session for a brief review of the skills learned during the session.</description>
    <arm_group_label>Virtual-Care Cognitive Behavioural Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 12 to 17 years old&#xD;
&#xD;
          -  Meet criteria for anxiety disorder as primary diagnosis&#xD;
&#xD;
          -  Parent(s)/primary caregiver(s) and children both proficient in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of developmental delay&#xD;
&#xD;
          -  Severity of comorbid psychopathology (e.g., bipolar disorder, psychosis) prohibits CBT&#xD;
             as first-line treatment&#xD;
&#xD;
          -  Lack of fluency in English (for parent(s)/primary caregiver(s) and/or children)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suneeta Monga, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children (SickKids)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hospital for Sick Children (SickKids)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>World Health Organization. Health Equity. Geneva; 2017.</citation>
  </reference>
  <reference>
    <citation>Ontario Ministry of Health and Long Term Care. Health Equity Guideline. Toronto, ON; 2018.</citation>
  </reference>
  <reference>
    <citation>Higa-McMillan CK, Francis SE, Rith-Najarian L, Chorpita BF. Evidence Base Update: 50 Years of Research on Treatment for Child and Adolescent Anxiety. J Clin Child Adolesc Psychol. 2016;45(2):91-113. doi: 10.1080/15374416.2015.1046177. Epub 2015 Jun 18.</citation>
    <PMID>26087438</PMID>
  </reference>
  <reference>
    <citation>Seligman LD, Ollendick TH. Cognitive-behavioral therapy for anxiety disorders in youth. Child Adolesc Psychiatr Clin N Am. 2011 Apr;20(2):217-38. doi: 10.1016/j.chc.2011.01.003.</citation>
    <PMID>21440852</PMID>
  </reference>
  <reference>
    <citation>Carpenter AL, Pincus DB, Furr JM, Comer JS. Working From Home: An Initial Pilot Examination of Videoconferencing-Based Cognitive Behavioral Therapy for Anxious Youth Delivered to the Home Setting. Behav Ther. 2018 Nov;49(6):917-930. doi: 10.1016/j.beth.2018.01.007. Epub 2018 Mar 5.</citation>
    <PMID>30316490</PMID>
  </reference>
  <reference>
    <citation>Slone NC, Reese RJ, McClellan MJ. Telepsychology outcome research with children and adolescents: a review of the literature. Psychol Serv. 2012 Aug;9(3):272-292. doi: 10.1037/a0027607.</citation>
    <PMID>22867120</PMID>
  </reference>
  <reference>
    <citation>Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.</citation>
    <PMID>18183564</PMID>
  </reference>
  <reference>
    <citation>Tracey T, Kokotovic A. Factor structure of the Working Alliance Inventory. Psychological Assessmen. Psychol Assess. 1989;1(3):207-210. doi:10.1037/1040-3590.1.3.207</citation>
  </reference>
  <reference>
    <citation>Birmaher B, Khetarpal S, Brent D, Cully M, Balach L, Kaufman J, Neer SM. The Screen for Child Anxiety Related Emotional Disorders (SCARED): scale construction and psychometric characteristics. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):545-53. doi: 10.1097/00004583-199704000-00018.</citation>
    <PMID>9100430</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Suneeta Monga</investigator_full_name>
    <investigator_title>Associate Psychiatrist-In-Chief</investigator_title>
  </responsible_party>
  <keyword>anxiety disorder</keyword>
  <keyword>child</keyword>
  <keyword>adolescent</keyword>
  <keyword>virtual-care</keyword>
  <keyword>cognitive behavioural therapy</keyword>
  <keyword>COVID-19</keyword>
  <keyword>mental health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04408027
org study id: REB1000070362
nct id: NCT04408027
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coronavirus disease 2019 (COVID-19) and associated emergency measures (EM) have dramatically
      impacted the lives of children/adolescents (children) and families. The closure of schools,
      social and recreational activities, and modifications to work environments has led to
      significant changes in the way children and families are working, living and socializing.
      Although the impact on the mental health of children and families has not been well
      researched, it is anticipated that already stressed children and families with pre-COVID-19
      mental health challenges are at significant risk for deterioration in their mental health. As
      such, the implementation, and evaluation (specifically: feasibility, acceptability and
      barriers) of virtual-care interventions to alleviate child and family anxiety and enhance
      family functioning are critical. Virtual-care also optimizes health equity initiatives in
      reducing social, economic and environmental barriers to services that can improve or maintain
      mental health (WHO, 2017; MOHLTC, 2018).

      The current study will evaluate an adapted virtual-care cognitive behavioural therapy (CBT)
      program for children with anxiety (VC-CBT). CBT has a strong evidence-base in treating
      children with anxiety disorders (Higa-McMillan, Francis, Rith-Najarian, and Chorpita, 2016;
      Seligman and Ollendick, 2011), with increasing evidence supporting the efficacy of
      virtual-care CBT for childhood anxiety disorders (Carpenter, Pincus, Furr, and Comer, 2018;
      Slone, Reese, and McClellan, 2012). This study aims to evaluate the feasibility,
      participation barriers related to social determinants of health (SDH) and acceptability of
      this virtual-care intervention in addressing mental health challenges associated with the
      COVID-19 pandemic and ensuing EM in the immediate time-period. Early evaluation of this
      virtual-care intervention will enable future scale-up of this intervention during the
      post-pandemic recovery time-period and during subsequent COVID-19 waves, if necessary.
Study Design: This is a pragmatic prospective pre-post feasibility study to assess whether
      virtual-care delivery of mental health interventions are acceptable and feasible with regard
      to recruitment and retention, participation barriers (inclusive of SDH barriers), child and
      parent acceptability, and adherence. Targeted symptoms of the intervention (e.g., child
      anxiety) will be evaluated as secondary outcomes to gather preliminary data on efficacy.

      Estimated Sample Size: In this first feasibility phase, participants will include children
      referred for treatment to Psychiatry. For the purpose of this pragmatic trial, we aim to
      recruit 20 participants for this intervention. According to Hertzog, a sample size of 20
      participants is adequate for pilot studies to examine intervention feasibility and to develop
      estimates of variance to compute power for larger studies (Hertzog, 2008).

      Data Analyses: Data for demographic variables will be summarized using counts, percentages,
      measures of central tendency (mean, median, and mode) and measures of sample variation
      (standard deviation, range). Parametric statistics (mean, standard deviation) will be used
      for interval and ratio data. To assess the feasibility and acceptability of this
      intervention, results will include analyses of recruitment, social determinant barriers and
      adherence rates and responses to satisfaction/evaluation and alliance scales. Pre-post
      analysis will also include comparing mean changes in COVID specific distress, and
      intervention specific comparisons of child anxiety.

      Knowledge Translation: Our integrated Knowledge-to-action (iKTA) approach has involved
      family, clinician and scientist engagement from the outset and will continue to do so.
      Participants will receive updates through e-newsletters and information through email.
      Knowledge gained will be presented at conferences and publications to further the impact of
      generating future hypothesis-driven research and funding support.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The current study will leverage an adapted virtual-care cognitive behavioural therapy program for children with anxiety (VC-CBT). The VC-CBT protocol will involve 12 sessions (of one hour in duration) delivered by a CBT therapist using PHIPA (Personal Health Information Protection Act) compliant Zoom. An initial session will review therapy goals and psychoeducation about anxiety. Sessions 2 and 3 will focus on feeling identification and will introduce relaxation strategies. Sessions 4 and 5 will introduce cognitive distortions and restructuring strategies. Sessions 6 and 7 will introduce exposure tasks. Sessions 8 to 11 will involve practicing cognitive restructuring skills and completing exposures. The final session will review relapse prevention. Parents will participate in the first and last sessions, as well as join at the end of each session for a brief review of the skills learned during the session.
primary purpose: Treatment
masking: None (Open Label)
measure: Participation Barriers
time frame: The Social Determinants of Health Questionnaire will be administered at baseline only, for each participant (approximately one week prior to the first of twelve sessions in the intervention).
description: Participation barriers related to Social Determinants of Health (SDH) will be captured to assess intervention feasibility. Participation barriers will be captured using the Social Determinants of Health Questionnaire (unpublished).
measure: Number of Eligible Participants
time frame: The number of participants that were eligible for the study will be captured through study completion, estimated at approximately 1 year.
description: Number of participants that were eligible for the study.
measure: Number of Participants Approached
time frame: The number of participants that were approached for the study will be captured through study completion, estimated at approximately 1 year.
description: Number of participants that were approached for the study.
measure: Number of Participants Consented
time frame: The number of participants that were consented for the study will be captured through study completion, estimated at approximately 1 year.
description: Number of participants consented for the study.
measure: Rates of Refusal
time frame: The rates of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.
description: Rates of refusal for participation in the study.
measure: Reasons for Refusal
time frame: The reasons of refusal for participation in the study will be assessed through study completion, estimated at approximately 1 year.
description: Reasons for refusal for participation in the study.
measure: Number of Sessions Completed in Total
time frame: The average number of sessions completed in total, for each participant, will be assessed through study completion, estimated at approximately 1 year.
description: The average number of sessions completed in total will be captured to evaluate intervention adherence.
measure: Adherence Index
time frame: The adherence index, for each participant, will be assessed through study completion, estimated at approximately 1 year.
description: The adherence index (calculated using the formula: sessions completed/total sessions scheduled [sum of sessions attended, rescheduled, no-showed and cancelled]) will be used to evaluate intervention adherence.
measure: Amount of time (in weeks) to complete the intervention
time frame: The amount of time (in weeks) to complete the intervention, for each participant, will be assessed through study completion, estimated at approximately 1 year.
description: The amount of time (in weeks) to complete the intervention will be captured to evaluate intervention implementation experience.
measure: Intervention Acceptability
time frame: The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).
description: The measure that will be used to assess the primary outcome of intervention acceptability is the Virtual Care Satisfaction Survey (Romanchych, unpublished).
measure: Participant Satisfaction
time frame: The Virtual Care Satisfaction Survey will be administered once, within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).
description: The measure that will be used to assess participant satisfaction is the Virtual Care Satisfaction Survey (Romanchych, unpublished).
measure: Working Alliance Inventory after First Intervention Session
time frame: The Working Alliance Inventory will be administered within approximately one week after completion of the first intervention session (estimated to occur approximately 1 to 2 weeks after initiation of the study).
description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).
measure: Working Alliance Inventory after Sixth Intervention Session
time frame: The Working Alliance Inventory will be administered within approximately one week after completion of the sixth intervention session (estimated to occur approximately 6 to 8 weeks after initiation of the study).
description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).
measure: Working Alliance Inventory after Final Intervention Session
time frame: The Working Alliance Inventory will be administered within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after initiation of the study).
description: The Working Alliance Inventory will be used to assess participant satisfaction (WAI; Tracy & Kokotovic, 1989).
measure: Family Impact During a Pandemic at Baseline
time frame: CRISIS (parent/caregiver and youth forms) will be completed virtually by children and parents at baseline (approximately one week prior to the first of twelve sessions in the intervention).
description: Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Baseline Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.
measure: Family Impact During a Pandemic after Final Intervention Session
time frame: CRISIS forms will be completed virtually by children and parents, within approximately one week of completion of the twelfth (final) intervention session (approximately 12 to 16 weeks after initiation of the study).
description: Coronavirus disease 2019 (COVID-19) specific distress will be assessed using the CoRonavIruS Health Impact Survey (CRISIS; Merikangas et al., unpublished) V0.1 Parent/Caregiver or Youth Follow-Up Form. Many items from this scale address social determinants of health, which will allow for understanding of family social determinants of health at baseline and over the course of the virtual-care treatment.
measure: Efficacy of Virtual-Care CBT Intervention
time frame: The SCARED questionnaire will be completed at both baseline and within approximately one week after completion of the twelfth (final) intervention session (estimated to occur approximately 12 to 16 weeks after study initiation).
description: To evaluate the efficacy of the virtual-care CBT intervention, change in child anxiety will be measured using child and parent-report Screen for Child Anxiety Related Disorders (SCARED; Birmaher et al., 1997). The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. In addition, it assesses symptoms related to school phobia. A total score of 25 of higher on the SCARED measure may indicate the presence of an anxiety disorder. Scores higher than 30 are more specific.
measure: Clinician Virtual Care Experience
time frame: The Clinician Virtual Care Survey will be completed virtually by clinicians at both SickKids and CCMH at baseline.
description: In order to evaluate the experience of clinicians (at The Hospital for Sick Children (SickKids) and the Centre for Community Mental Health (CCMH)) using virtual-care platforms during the work from home shift due to COVID-19 and to identify any challenges they may be facing, a Clinician Virtual Care Experience Survey (Romanchych, unpublished) will be administered.
arm group label: Virtual-Care Cognitive Behavioural Therapy
arm group type: Experimental
intervention type: Behavioral
intervention name: Virtual-Care Cognitive Behavioural Therapy
description: The feasibility, participation barriers, and acceptability of the intervention, virtual-care cognitive behavioural therapy (VC-CBT), will be evaluated for children with anxiety. The VC-CBT protocol will involve 12 sessions (of one hour in duration) delivered by a CBT therapist using PHIPA (Personal Health Information Protection Act) compliant Zoom. An initial session will review therapy goals and psychoeducation about anxiety. Sessions 2 and 3 will focus on feeling identification and will introduce relaxation strategies. Sessions 4 and 5 will introduce cognitive distortions and restructuring strategies. Sessions 6 and 7 will introduce exposure tasks. Sessions 8 to 11 will involve practicing cognitive restructuring skills and completing exposures. The final session will review relapse prevention. Parents will participate in the first and last sessions, as well as join at the end of each session for a brief review of the skills learned during the session.
arm group label: Virtual-Care Cognitive Behavioural Therapy
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Suneeta Monga, MD, FRCPC
role: Principal Investigator
affiliation: The Hospital for Sick Children (SickKids)
facility: 
country: Canada
citation: World Health Organization. Health Equity. Geneva; 2017.
citation: Ontario Ministry of Health and Long Term Care. Health Equity Guideline. Toronto, ON; 2018.
citation: Higa-McMillan CK, Francis SE, Rith-Najarian L, Chorpita BF. Evidence Base Update: 50 Years of Research on Treatment for Child and Adolescent Anxiety. J Clin Child Adolesc Psychol. 2016;45(2):91-113. doi: 10.1080/15374416.2015.1046177. Epub 2015 Jun 18.
PMID: 26087438
citation: Seligman LD, Ollendick TH. Cognitive-behavioral therapy for anxiety disorders in youth. Child Adolesc Psychiatr Clin N Am. 2011 Apr;20(2):217-38. doi: 10.1016/j.chc.2011.01.003.
PMID: 21440852
citation: Carpenter AL, Pincus DB, Furr JM, Comer JS. Working From Home: An Initial Pilot Examination of Videoconferencing-Based Cognitive Behavioral Therapy for Anxious Youth Delivered to the Home Setting. Behav Ther. 2018 Nov;49(6):917-930. doi: 10.1016/j.beth.2018.01.007. Epub 2018 Mar 5.
PMID: 30316490
citation: Slone NC, Reese RJ, McClellan MJ. Telepsychology outcome research with children and adolescents: a review of the literature. Psychol Serv. 2012 Aug;9(3):272-292. doi: 10.1037/a0027607.
PMID: 22867120
citation: Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
PMID: 18183564
citation: Tracey T, Kokotovic A. Factor structure of the Working Alliance Inventory. Psychological Assessmen. Psychol Assess. 1989;1(3):207-210. doi:10.1037/1040-3590.1.3.207
citation: Birmaher B, Khetarpal S, Brent D, Cully M, Balach L, Kaufman J, Neer SM. The Screen for Child Anxiety Related Emotional Disorders (SCARED): scale construction and psychometric characteristics. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):545-53. doi: 10.1097/00004583-199704000-00018.
PMID: 9100430
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Suneeta Monga
investigator title: Associate Psychiatrist-In-Chief
mesh term: COVID-19
mesh term: Anxiety Disorders
sharing ipd: No