<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/NCT03269370</url>
  </required_header>
  <id_info>
    <org_study_id>2R44MH098470-03</org_study_id>
    <nct_id>NCT03269370</nct_id>
  </id_info>
  <brief_title>Family-Focused CBT Skills App and Standard Self Help Options for Childhood Anxiety</brief_title>
  <official_title>Randomized Controlled Trial of a Family-focused CBT Skills App and Standard Self Help Options for Childhood Anxiety and Related Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kansas City Center for Anxiety Treatment, P.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Virtually Better, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kansas City Center for Anxiety Treatment, P.A.</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>
      Anxiety disorders are among the most common psychological disorders, with prevalent onset in&#xD;
      childhood and adolescence. While cognitive behavioral therapy (CBT) is considered the&#xD;
      first-line treatment for pediatric anxiety, significant barriers remain in accessing CBT and&#xD;
      other evidence-based treatments (EBTs), and credible self-help resources based in EBT&#xD;
      concepts. This study evaluates a family-guided CBT game application (Anchors App), targeted&#xD;
      to children ages 6-11 and their families, which focuses on delivering adaptive CBT-based&#xD;
      coping skills to those who have sub-clinical to mild anxiety and related symptoms in a&#xD;
      convenient and portable platform. Anchors App will be evaluated in two forms (standard and&#xD;
      &quot;parent-enhanced&quot;) in comparison to use of a self-help book or waitlist control. The rapid&#xD;
      advancements in technology allows richer interactive capacity, content scalability,&#xD;
      customizability, and subscription to a broader range of content, which this app capitalizes&#xD;
      on in order to increase access to CBT skill concepts directly to pediatric stakeholder&#xD;
      populations. If found to be effective, Anchors App has the opportunity to promote engagement&#xD;
      of EBT concepts in every-day use through smartphone technology, and will change the landscape&#xD;
      of mental health prevention and early intervention for children and families.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Parallel Assignment</intervention_model>
    <intervention_model_description>RCT with 4 arms, one being a waitlist arm that allows for re-randomization into one of the 3 &quot;active&quot; study arms.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>There is no masking in this study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Spence Children's Anxiety Scale - Parent/Child Report (SCAS)</measure>
    <time_frame>Entry into study, 6 weeks, 12 weeks</time_frame>
    <description>Parent and child report of anxiety with 6 DSM-IV criteria sub scales. Measuring change in reported anxiety levels in these 6 different domains over time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DASS-21</measure>
    <time_frame>Entry into study, 6 weeks, 12 weeks</time_frame>
    <description>A screener for overall psychological distress of parent with sub scales assessing anxiety, depression, and stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Centre for Epidemiological Studies- Depression Scale for Children (CES-DC)</measure>
    <time_frame>Entry into study, 6 weeks, 12 weeks</time_frame>
    <description>A 20-item screener for childhood depression and psychological distress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Sensitivity Index- 3 (ASI-3)</measure>
    <time_frame>Entry into study, 6 weeks, 12 weeks</time_frame>
    <description>A measure of parent anxiety sensitivity (fear of arousal-related sensations) in physical, social, and cognitive domains</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Anxiety Sensitivity Index (CASI)</measure>
    <time_frame>Entry into study, 6 weeks, 12 weeks</time_frame>
    <description>A measure of sensitivity to symptoms of anxiety, similar to the ASI, measuring physical, social, and mental incapacitation concerns in children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral Inhibition Instrument (BII)</measure>
    <time_frame>Entry into study, 6 weeks, 12 weeks</time_frame>
    <description>A parent-report measure of child behavioral inhibition, which has been determined to be a risk factor for later psychopathology, particularly anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Status and Parent Confidence</measure>
    <time_frame>Entry into study, 3 weeks, 6 weeks, 12 weeks</time_frame>
    <description>Self-report measure to ensure the child is not receiving outside interventions (as would disqualify them from study) and to gauge parents' confidence in managing child's symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opinion on Intervention</measure>
    <time_frame>6 weeks</time_frame>
    <description>Self-report measure to gauge families' thoughts on user-friendliness, perceived effectiveness of intervention, and likelihood to use again or recommend to others</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Anxiety Disorders</condition>
  <condition>Childhood Mental Disorder</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>1: Anchors Away</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family will receive access to the basic Anchors Away mobile app to test over 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2: Parent Enhanced Anchors Away</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family will receive access to the Parent Enhanced Anchors Away mobile app to test over 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3: Self-Help E-Book</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 3 will receive the Self Help e-Book as a comparative condition (families provided a kindle version copy of &quot;Helping Your Anxious Child: A Step-by-Step Guide&quot; ; Rapee, Wignall, Spence, Lyneham, &amp; Cobham, 2008).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4: Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group 4 will not receive any intervention, but will be randomized into an active study arm at 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Anchors Away</intervention_name>
    <description>Modular Cognitive Behavioral Therapy delivered through a mobile app.</description>
    <arm_group_label>1: Anchors Away</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent Enhanced Anchors Away</intervention_name>
    <description>Modular Cognitive Behavioral Therapy delivered through a mobile app. Extra modules will focus specifically on parenting skills relevant to having an anxious child.</description>
    <arm_group_label>2: Parent Enhanced Anchors Away</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-Help E-Book</intervention_name>
    <description>Parents will read &quot;Helping Your Anxious Child: A Step-by-Step Guide&quot; (Rapee, Wignall, Spence, Lyneham, &amp; Cobham, 2008)</description>
    <arm_group_label>3: Self-Help E-Book</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Availability of mobile technology (e.g., smart phone, tablet)&#xD;
&#xD;
          -  Internet access&#xD;
&#xD;
          -  English language spoken in the home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child in current or recent (last 2 months) psychotherapy&#xD;
&#xD;
          -  Child currently taking psychotropic medication&#xD;
&#xD;
          -  Parent or child endorsing symptom greater than 2 standard deviations above the mean on&#xD;
             clinical measures&#xD;
&#xD;
          -  Parents express feeling unable to assist child with current degree of symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn D Kriegshauser, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kansas City Center for Anxiety Treatment, P.A.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa R Hale, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kansas City Center for Anxiety Treatment, P.A.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Margo Adams Larsen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virtually Better, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kansas City Center for Anxiety Treatment, P.A.</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CBT</keyword>
  <keyword>Self-Help</keyword>
  <keyword>Family</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Mental 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/NCT03269370
org study id: 2R44MH098470-03
nct id: NCT03269370
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anxiety disorders are among the most common psychological disorders, with prevalent onset in
      childhood and adolescence. While cognitive behavioral therapy (CBT) is considered the
      first-line treatment for pediatric anxiety, significant barriers remain in accessing CBT and
      other evidence-based treatments (EBTs), and credible self-help resources based in EBT
      concepts. This study evaluates a family-guided CBT game application (Anchors App), targeted
      to children ages 6-11 and their families, which focuses on delivering adaptive CBT-based
      coping skills to those who have sub-clinical to mild anxiety and related symptoms in a
      convenient and portable platform. Anchors App will be evaluated in two forms (standard and
      "parent-enhanced") in comparison to use of a self-help book or waitlist control. The rapid
      advancements in technology allows richer interactive capacity, content scalability,
      customizability, and subscription to a broader range of content, which this app capitalizes
      on in order to increase access to CBT skill concepts directly to pediatric stakeholder
      populations. If found to be effective, Anchors App has the opportunity to promote engagement
      of EBT concepts in every-day use through smartphone technology, and will change the landscape
      of mental health prevention and early intervention for children and families.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: RCT with 4 arms, one being a waitlist arm that allows for re-randomization into one of the 3 "active" study arms.
primary purpose: Prevention
masking: None (Open Label)
masking description: There is no masking in this study.
measure: Spence Children's Anxiety Scale - Parent/Child Report (SCAS)
time frame: Entry into study, 6 weeks, 12 weeks
description: Parent and child report of anxiety with 6 DSM-IV criteria sub scales. Measuring change in reported anxiety levels in these 6 different domains over time.
measure: DASS-21
time frame: Entry into study, 6 weeks, 12 weeks
description: A screener for overall psychological distress of parent with sub scales assessing anxiety, depression, and stress.
measure: Centre for Epidemiological Studies- Depression Scale for Children (CES-DC)
time frame: Entry into study, 6 weeks, 12 weeks
description: A 20-item screener for childhood depression and psychological distress
measure: Anxiety Sensitivity Index- 3 (ASI-3)
time frame: Entry into study, 6 weeks, 12 weeks
description: A measure of parent anxiety sensitivity (fear of arousal-related sensations) in physical, social, and cognitive domains
measure: Child Anxiety Sensitivity Index (CASI)
time frame: Entry into study, 6 weeks, 12 weeks
description: A measure of sensitivity to symptoms of anxiety, similar to the ASI, measuring physical, social, and mental incapacitation concerns in children.
measure: Behavioral Inhibition Instrument (BII)
time frame: Entry into study, 6 weeks, 12 weeks
description: A parent-report measure of child behavioral inhibition, which has been determined to be a risk factor for later psychopathology, particularly anxiety.
measure: Treatment Status and Parent Confidence
time frame: Entry into study, 3 weeks, 6 weeks, 12 weeks
description: Self-report measure to ensure the child is not receiving outside interventions (as would disqualify them from study) and to gauge parents' confidence in managing child's symptoms
measure: Opinion on Intervention
time frame: 6 weeks
description: Self-report measure to gauge families' thoughts on user-friendliness, perceived effectiveness of intervention, and likelihood to use again or recommend to others
arm group label: 1: Anchors Away
arm group type: Experimental
description: Family will receive access to the basic Anchors Away mobile app to test over 6 weeks.
arm group label: 2: Parent Enhanced Anchors Away
arm group type: Experimental
description: Family will receive access to the Parent Enhanced Anchors Away mobile app to test over 6 weeks.
arm group label: 3: Self-Help E-Book
arm group type: Active Comparator
description: Group 3 will receive the Self Help e-Book as a comparative condition (families provided a kindle version copy of "Helping Your Anxious Child: A Step-by-Step Guide" ; Rapee, Wignall, Spence, Lyneham, & Cobham, 2008).
arm group label: 4: Waitlist Control
arm group type: No Intervention
description: Group 4 will not receive any intervention, but will be randomized into an active study arm at 6 weeks.
intervention type: Behavioral
intervention name: Anchors Away
description: Modular Cognitive Behavioral Therapy delivered through a mobile app.
arm group label: 1: Anchors Away
intervention type: Behavioral
intervention name: Parent Enhanced Anchors Away
description: Modular Cognitive Behavioral Therapy delivered through a mobile app. Extra modules will focus specifically on parenting skills relevant to having an anxious child.
arm group label: 2: Parent Enhanced Anchors Away
intervention type: Behavioral
intervention name: Self-Help E-Book
description: Parents will read "Helping Your Anxious Child: A Step-by-Step Guide" (Rapee, Wignall, Spence, Lyneham, & Cobham, 2008)
arm group label: 3: Self-Help E-Book
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathryn D Kriegshauser, PhD
role: Principal Investigator
affiliation: Kansas City Center for Anxiety Treatment, P.A.
last name: Lisa R Hale, PhD
role: Principal Investigator
affiliation: Kansas City Center for Anxiety Treatment, P.A.
last name: Margo Adams Larsen, PhD
role: Principal Investigator
affiliation: Virtually Better, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anxiety Disorders
mesh term: Mental Disorders
sharing ipd: No