<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/NCT02998502</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00097094</org_study_id>
    <nct_id>NCT02998502</nct_id>
  </id_info>
  <brief_title>The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens</brief_title>
  <official_title>Efficacy of a Biofeedback Breathing System for Anxiety and Panic Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Palo Alto Health Sciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</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>
      This study will test the efficiency of the Freespira Breathing System in youth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Freespira Breathing System (FBS; www.freespira.com) developed by Palo Alto Health&#xD;
      Sciences, Inc, is a portable home device , and has been employed in breathing biofeedback in&#xD;
      adults with panic disorder (PD). The FBS has now received FDA clearance for the treatment of&#xD;
      PD adults and is currently commercially available and more than 150 therapist have provided&#xD;
      the service nationally. However, FBS has not yet been tested for efficacy in a pediatric&#xD;
      populations. Due to its portability, FBS may pose an advantage for use in younger age groups,&#xD;
      compared to multiple therapy sessions required for cognitive behavioral therapy (CBT) or&#xD;
      lower acceptability for long-term medication use for adolescent PD.&#xD;
&#xD;
      In this pilot intervention study, the efficacy of the FBS system in youth will be tested. In&#xD;
      children adolescents, PD itself is less common than in adults, but when present, PD is&#xD;
      commonly associated with and/or preceded by other anxiety conditions, including generalized&#xD;
      anxiety disorder (GAD), social phobia (SoP) and separation anxiety (SAD). Thus, in children&#xD;
      and adolescents, the breathing biofeedback intervention for panic, should include other&#xD;
      anxiety disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 5, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Screen for Child Anxiety Related Disorders (SCARED) scale score</measure>
    <time_frame>8-weeks</time_frame>
    <description>The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SCARED anxiety scale score</measure>
    <time_frame>Baseline</time_frame>
    <description>The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCARED anxiety scale score</measure>
    <time_frame>Week 4 Follow Up</time_frame>
    <description>The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCARED anxiety scale score</measure>
    <time_frame>Week 8 Follow Up</time_frame>
    <description>The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCARED anxiety scale score</measure>
    <time_frame>6-month Follow Up</time_frame>
    <description>The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCARED anxiety scale score</measure>
    <time_frame>12-month Follow Up</time_frame>
    <description>The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End-tidal carbon dioxide (CO2)</measure>
    <time_frame>4 weeks</time_frame>
    <description>End-tidal CO2 at 4 weeks Measured using Freespira breathing system 4 minutes breathing session Parameters number of millimeters per mercury.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory rate level</measure>
    <time_frame>4 weeks</time_frame>
    <description>Respiratory rate at 4 weeks Measured using Freespira breathing system 4 minutes breathing session. The parameters are number of breaths per minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Panic Disorder Severity Scale for Adolescents (PDSS-A)</measure>
    <time_frame>Baseline</time_frame>
    <description>Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Panic Disorder Severity Scale for Adolescents (PDSS-A)</measure>
    <time_frame>Week 4 Follow Up</time_frame>
    <description>Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Panic Disorder Severity Scale for Adolescents (PDSS-A)</measure>
    <time_frame>Week 8 Follow Up</time_frame>
    <description>Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Panic Disorder Severity Scale for Adolescents (PDSS-A)</measure>
    <time_frame>6-Month Follow Up</time_frame>
    <description>Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Panic Disorder Severity Scale for Adolescents (PDSS-A)</measure>
    <time_frame>12 month Follow Up</time_frame>
    <description>Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician's Global Impression scale.</measure>
    <time_frame>Baseline</time_frame>
    <description>Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score.&#xD;
This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician's Global Impression scale.</measure>
    <time_frame>Week 4 Follow Up</time_frame>
    <description>Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score.&#xD;
This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician's Global Impression scale.</measure>
    <time_frame>Week 8 Follow Up</time_frame>
    <description>Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score.&#xD;
This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Yale Brown Obsessive-Compulsive Scale score</measure>
    <time_frame>Baseline</time_frame>
    <description>Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Yale Brown Obsessive-Compulsive Scale score</measure>
    <time_frame>Week 4 Follow Up</time_frame>
    <description>Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Yale Brown Obsessive-Compulsive Scale score</measure>
    <time_frame>Week 8 Follow Up</time_frame>
    <description>Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)</measure>
    <time_frame>Week 8</time_frame>
    <description>Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Child Sheehan Disability Scale (CSDS)</measure>
    <time_frame>Baseline</time_frame>
    <description>The CSDS was designed to measure the extent to which the child's anxiety symptoms were interfering with daily functioning. The CSDS is an adaptation of the Sheehan Disability Scale and consisted of items inquiring about the degree to which the child's anxiety symptoms interfere with school, social, and family functioning. As on the SDS, items are measured on an 11-point Likert-type scale ranging from 0 (not at all) to 10 (very, very much) .The wording of the anchors on the SDS was adapted to be more appropriate for children. A parent version (CSDS-P) that included six items was also created. The CSDS-P included three items that assessed the degree to which the parents perceived the child's anxiety symptoms to be interfering with the child's functioning (school, social, family) as well as three items that assessed the degree to which the child's symptoms were viewed as interfering with the parent's functioning (work, social, family).</description>
  </other_outcome>
  <other_outcome>
    <measure>Child Sheehan Disability Scale (CSDS)</measure>
    <time_frame>Week 4 Follow Up</time_frame>
    <description>The CSDS was designed to measure the extent to which the child's anxiety symptoms were interfering with daily functioning. The CSDS is an adaptation of the Sheehan Disability Scale and consisted of items inquiring about the degree to which the child's anxiety symptoms interfere with school, social, and family functioning. As on the SDS, items are measured on an 11-point Likert-type scale ranging from 0 (not at all) to 10 (very, very much) .The wording of the anchors on the SDS was adapted to be more appropriate for children. A parent version (CSDS-P) that included six items was also created. The CSDS-P included three items that assessed the degree to which the parents perceived the child's anxiety symptoms to be interfering with the child's functioning (school, social, family) as well as three items that assessed the degree to which the child's symptoms were viewed as interfering with the parent's functioning (work, social, family).</description>
  </other_outcome>
  <other_outcome>
    <measure>Child Sheehan Disability Scale (CSDS)</measure>
    <time_frame>Week 8 Follow Up</time_frame>
    <description>The CSDS was designed to measure the extent to which the child's anxiety symptoms were interfering with daily functioning. The CSDS is an adaptation of the Sheehan Disability Scale and consisted of items inquiring about the degree to which the child's anxiety symptoms interfere with school, social, and family functioning. As on the SDS, items are measured on an 11-point Likert-type scale ranging from 0 (not at all) to 10 (very, very much) .The wording of the anchors on the SDS was adapted to be more appropriate for children. A parent version (CSDS-P) that included six items was also created. The CSDS-P included three items that assessed the degree to which the parents perceived the child's anxiety symptoms to be interfering with the child's functioning (school, social, family) as well as three items that assessed the degree to which the child's symptoms were viewed as interfering with the parent's functioning (work, social, family).</description>
  </other_outcome>
  <other_outcome>
    <measure>Children's Depression Inventory ( CDI2)</measure>
    <time_frame>Baseline</time_frame>
    <description>The Children's Depression Inventory (CDI and CDI2) is a psychological assessment that rates the severity of symptoms related to depression or dysthymic disorder in children and adolescents. The CDI is a 27-item scale that is self-rated and symptom-oriented. The assessment is now in its second edition. The 27 items on the assessment are grouped into five major factor areas. Clients rate themselves based on how they feel and think, with each statement being identified with a rating from 0 to 2.</description>
  </other_outcome>
  <other_outcome>
    <measure>Children's Depression Inventory ( CDI2)</measure>
    <time_frame>Week 4 Follow Up</time_frame>
    <description>The Children's Depression Inventory (CDI and CDI2) is a psychological assessment that rates the severity of symptoms related to depression or dysthymic disorder in children and adolescents. The CDI is a 27-item scale that is self-rated and symptom-oriented. The assessment is now in its second edition. The 27 items on the assessment are grouped into five major factor areas. Clients rate themselves based on how they feel and think, with each statement being identified with a rating from 0 to 2.</description>
  </other_outcome>
  <other_outcome>
    <measure>Children's Depression Inventory ( CDI2)</measure>
    <time_frame>Week 8 Follow Up</time_frame>
    <description>The Children's Depression Inventory (CDI and CDI2) is a psychological assessment that rates the severity of symptoms related to depression or dysthymic disorder in children and adolescents. The CDI is a 27-item scale that is self-rated and symptom-oriented. The assessment is now in its second edition. The 27 items on the assessment are grouped into five major factor areas. Clients rate themselves based on how they feel and think, with each statement being identified with a rating from 0 to 2.</description>
  </other_outcome>
  <other_outcome>
    <measure>Childhood Anxiety Sensitivity Index (CASI)</measure>
    <time_frame>Baseline</time_frame>
    <description>The Child Anxiety Sensitivity Index is an 18-item scale which measures anxiety sensitivity by asking children to state how aversely they view anxiety symptoms. The child is to mark either &quot;none&quot; (I), &quot;some&quot; (2), or &quot;A Lot&quot; (3) to each item. The child's total anxiety sensitivity score is the sum of his or her points.</description>
  </other_outcome>
  <other_outcome>
    <measure>Childhood Anxiety Sensitivity Index (CASI)</measure>
    <time_frame>Week 4 Follow Up</time_frame>
    <description>The Child Anxiety Sensitivity Index is an 18-item scale which measures anxiety sensitivity by asking children to state how aversely they view anxiety symptoms. The child is to mark either &quot;none&quot; (I), &quot;some&quot; (2), or &quot;A Lot&quot; (3) to each item. The child's total anxiety sensitivity score is the sum of his or her points.</description>
  </other_outcome>
  <other_outcome>
    <measure>Childhood Anxiety Sensitivity Index (CASI)</measure>
    <time_frame>Week 8 Follow Up</time_frame>
    <description>The Child Anxiety Sensitivity Index is an 18-item scale which measures anxiety sensitivity by asking children to state how aversely they view anxiety symptoms. The child is to mark either &quot;none&quot; (I), &quot;some&quot; (2), or &quot;A Lot&quot; (3) to each item. The child's total anxiety sensitivity score is the sum of his or her points.</description>
  </other_outcome>
  <other_outcome>
    <measure>Junior Temperament and Character Inventory (JTCI)</measure>
    <time_frame>Baseline</time_frame>
    <description>The Junior Temperament and Character Inventory (JTCI) was developed to assess the temperament ('novelty seeking', 'harm avoidance', 'reward dependence', 'persistence') and character ('self-directedness', 'cooperativeness', 'self-transcendence') dimensions of Cloninger's bio-social model of personality in children and adolescents. Each of the 108 statements can be answered &quot;True&quot; or &quot;False&quot;. The parent is to decide which choice best fits the child they are describing in this questionnaire.</description>
  </other_outcome>
  <other_outcome>
    <measure>Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)</measure>
    <time_frame>Baseline</time_frame>
    <description>The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a semi-structured interview aimed at early diagnosis of affective disorders such as depression, bipolar disorder, and anxiety disorder. There are currently four different versions of the test that are structured to include interviews with both the child and the parents or guardians.</description>
  </other_outcome>
  <other_outcome>
    <measure>Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)</measure>
    <time_frame>Week 4 Follow Up</time_frame>
    <description>The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a semi-structured interview aimed at early diagnosis of affective disorders such as depression, bipolar disorder, and anxiety disorder. There are currently four different versions of the test that are structured to include interviews with both the child and the parents or guardians.</description>
  </other_outcome>
  <other_outcome>
    <measure>Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)</measure>
    <time_frame>Week 8 Follow Up</time_frame>
    <description>The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a semi-structured interview aimed at early diagnosis of affective disorders such as depression, bipolar disorder, and anxiety disorder. There are currently four different versions of the test that are structured to include interviews with both the child and the parents or guardians.</description>
  </other_outcome>
  <other_outcome>
    <measure>Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)</measure>
    <time_frame>12 month Follow Up</time_frame>
    <description>The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a semi-structured interview aimed at early diagnosis of affective disorders such as depression, bipolar disorder, and anxiety disorder. There are currently four different versions of the test that are structured to include interviews with both the child and the parents or guardians.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Anxiety</condition>
  <condition>Panic Disorder</condition>
  <arm_group>
    <arm_group_label>Device Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a portable home device used for breathing biofeedback in adults with PD. FBS has now received FDA clearance for the treatment of PD adults and is currently commercially available and more than 150 therapist have provided the service nationally. However, FBS has not yet been tested for efficacy in a pediatric populations. Due to its portability, FBS may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for CBT or lower acceptability for long-term medication use for adolescent PD. In this pilot intervention study, the efficacy of the FBS system in youth will be tested.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The device will be given to those in the control group after 8-week baseline period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Freespira Breathing System</intervention_name>
    <description>Over an 8-week period the efficacy of the FBS system in youth will be tested, with those in the randomized active device group. The control group will not receive the device until completion of the 8 week baseline.</description>
    <arm_group_label>Device Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SCARED score ≥ 25 + prior clinical diagnosis of an anxiety disorder&#xD;
&#xD;
          -  Participants must be 9-17 years of age&#xD;
&#xD;
          -  If on psychotropic medication(s), participant must be on a stable dose for at least&#xD;
             one month prior to study enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anxiety has occurred exclusively during a major depressive episode, psychiatric&#xD;
             illness, dementia, intellectual disability, or brain disease&#xD;
&#xD;
          -  Currently enrolled in another device or drug study or less than 30 days has elapsed&#xD;
             since participation in such a study&#xD;
&#xD;
          -  Currently undergoing breathing biofeedback elsewhere&#xD;
&#xD;
          -  Demonstrate evidence of severe suicidal ideation or psychosis&#xD;
&#xD;
          -  There is an active condition of asthma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Grados, M.D., M.P.H.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obsessive Compulsive Disorder (OCD)</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Pediatrics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Panic Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT02998502/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT02998502/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02998502
org study id: IRB00097094
nct id: NCT02998502
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will test the efficiency of the Freespira Breathing System in youth.
The Freespira Breathing System (FBS; www.freespira.com) developed by Palo Alto Health
      Sciences, Inc, is a portable home device , and has been employed in breathing biofeedback in
      adults with panic disorder (PD). The FBS has now received FDA clearance for the treatment of
      PD adults and is currently commercially available and more than 150 therapist have provided
      the service nationally. However, FBS has not yet been tested for efficacy in a pediatric
      populations. Due to its portability, FBS may pose an advantage for use in younger age groups,
      compared to multiple therapy sessions required for cognitive behavioral therapy (CBT) or
      lower acceptability for long-term medication use for adolescent PD.

      In this pilot intervention study, the efficacy of the FBS system in youth will be tested. In
      children adolescents, PD itself is less common than in adults, but when present, PD is
      commonly associated with and/or preceded by other anxiety conditions, including generalized
      anxiety disorder (GAD), social phobia (SoP) and separation anxiety (SAD). Thus, in children
      and adolescents, the breathing biofeedback intervention for panic, should include other
      anxiety disorders.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Screen for Child Anxiety Related Disorders (SCARED) scale score
time frame: 8-weeks
description: The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
measure: SCARED anxiety scale score
time frame: Baseline
description: The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
measure: SCARED anxiety scale score
time frame: Week 4 Follow Up
description: The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
measure: SCARED anxiety scale score
time frame: Week 8 Follow Up
description: The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
measure: SCARED anxiety scale score
time frame: 6-month Follow Up
description: The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
measure: SCARED anxiety scale score
time frame: 12-month Follow Up
description: The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
measure: End-tidal carbon dioxide (CO2)
time frame: 4 weeks
description: End-tidal CO2 at 4 weeks Measured using Freespira breathing system 4 minutes breathing session Parameters number of millimeters per mercury.
measure: Respiratory rate level
time frame: 4 weeks
description: Respiratory rate at 4 weeks Measured using Freespira breathing system 4 minutes breathing session. The parameters are number of breaths per minute.
measure: Panic Disorder Severity Scale for Adolescents (PDSS-A)
time frame: Baseline
description: Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.
measure: Panic Disorder Severity Scale for Adolescents (PDSS-A)
time frame: Week 4 Follow Up
description: Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.
measure: Panic Disorder Severity Scale for Adolescents (PDSS-A)
time frame: Week 8 Follow Up
description: Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.
measure: Panic Disorder Severity Scale for Adolescents (PDSS-A)
time frame: 6-Month Follow Up
description: Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.
measure: Panic Disorder Severity Scale for Adolescents (PDSS-A)
time frame: 12 month Follow Up
description: Panic Disorder Severity Scale for Adolescents [PDSS-A] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.
measure: Clinician's Global Impression scale.
time frame: Baseline
description: Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score.
This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.
measure: Clinician's Global Impression scale.
time frame: Week 4 Follow Up
description: Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score.
This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.
measure: Clinician's Global Impression scale.
time frame: Week 8 Follow Up
description: Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score.
This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.
measure: Child Yale Brown Obsessive-Compulsive Scale score
time frame: Baseline
description: Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.
measure: Child Yale Brown Obsessive-Compulsive Scale score
time frame: Week 4 Follow Up
description: Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.
measure: Child Yale Brown Obsessive-Compulsive Scale score
time frame: Week 8 Follow Up
description: Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.
measure: Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)
time frame: Week 8
description: Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)
measure: Child Sheehan Disability Scale (CSDS)
time frame: Baseline
description: The CSDS was designed to measure the extent to which the child's anxiety symptoms were interfering with daily functioning. The CSDS is an adaptation of the Sheehan Disability Scale and consisted of items inquiring about the degree to which the child's anxiety symptoms interfere with school, social, and family functioning. As on the SDS, items are measured on an 11-point Likert-type scale ranging from 0 (not at all) to 10 (very, very much) .The wording of the anchors on the SDS was adapted to be more appropriate for children. A parent version (CSDS-P) that included six items was also created. The CSDS-P included three items that assessed the degree to which the parents perceived the child's anxiety symptoms to be interfering with the child's functioning (school, social, family) as well as three items that assessed the degree to which the child's symptoms were viewed as interfering with the parent's functioning (work, social, family).
measure: Child Sheehan Disability Scale (CSDS)
time frame: Week 4 Follow Up
description: The CSDS was designed to measure the extent to which the child's anxiety symptoms were interfering with daily functioning. The CSDS is an adaptation of the Sheehan Disability Scale and consisted of items inquiring about the degree to which the child's anxiety symptoms interfere with school, social, and family functioning. As on the SDS, items are measured on an 11-point Likert-type scale ranging from 0 (not at all) to 10 (very, very much) .The wording of the anchors on the SDS was adapted to be more appropriate for children. A parent version (CSDS-P) that included six items was also created. The CSDS-P included three items that assessed the degree to which the parents perceived the child's anxiety symptoms to be interfering with the child's functioning (school, social, family) as well as three items that assessed the degree to which the child's symptoms were viewed as interfering with the parent's functioning (work, social, family).
measure: Child Sheehan Disability Scale (CSDS)
time frame: Week 8 Follow Up
description: The CSDS was designed to measure the extent to which the child's anxiety symptoms were interfering with daily functioning. The CSDS is an adaptation of the Sheehan Disability Scale and consisted of items inquiring about the degree to which the child's anxiety symptoms interfere with school, social, and family functioning. As on the SDS, items are measured on an 11-point Likert-type scale ranging from 0 (not at all) to 10 (very, very much) .The wording of the anchors on the SDS was adapted to be more appropriate for children. A parent version (CSDS-P) that included six items was also created. The CSDS-P included three items that assessed the degree to which the parents perceived the child's anxiety symptoms to be interfering with the child's functioning (school, social, family) as well as three items that assessed the degree to which the child's symptoms were viewed as interfering with the parent's functioning (work, social, family).
measure: Children's Depression Inventory ( CDI2)
time frame: Baseline
description: The Children's Depression Inventory (CDI and CDI2) is a psychological assessment that rates the severity of symptoms related to depression or dysthymic disorder in children and adolescents. The CDI is a 27-item scale that is self-rated and symptom-oriented. The assessment is now in its second edition. The 27 items on the assessment are grouped into five major factor areas. Clients rate themselves based on how they feel and think, with each statement being identified with a rating from 0 to 2.
measure: Children's Depression Inventory ( CDI2)
time frame: Week 4 Follow Up
description: The Children's Depression Inventory (CDI and CDI2) is a psychological assessment that rates the severity of symptoms related to depression or dysthymic disorder in children and adolescents. The CDI is a 27-item scale that is self-rated and symptom-oriented. The assessment is now in its second edition. The 27 items on the assessment are grouped into five major factor areas. Clients rate themselves based on how they feel and think, with each statement being identified with a rating from 0 to 2.
measure: Children's Depression Inventory ( CDI2)
time frame: Week 8 Follow Up
description: The Children's Depression Inventory (CDI and CDI2) is a psychological assessment that rates the severity of symptoms related to depression or dysthymic disorder in children and adolescents. The CDI is a 27-item scale that is self-rated and symptom-oriented. The assessment is now in its second edition. The 27 items on the assessment are grouped into five major factor areas. Clients rate themselves based on how they feel and think, with each statement being identified with a rating from 0 to 2.
measure: Childhood Anxiety Sensitivity Index (CASI)
time frame: Baseline
description: The Child Anxiety Sensitivity Index is an 18-item scale which measures anxiety sensitivity by asking children to state how aversely they view anxiety symptoms. The child is to mark either "none" (I), "some" (2), or "A Lot" (3) to each item. The child's total anxiety sensitivity score is the sum of his or her points.
measure: Childhood Anxiety Sensitivity Index (CASI)
time frame: Week 4 Follow Up
description: The Child Anxiety Sensitivity Index is an 18-item scale which measures anxiety sensitivity by asking children to state how aversely they view anxiety symptoms. The child is to mark either "none" (I), "some" (2), or "A Lot" (3) to each item. The child's total anxiety sensitivity score is the sum of his or her points.
measure: Childhood Anxiety Sensitivity Index (CASI)
time frame: Week 8 Follow Up
description: The Child Anxiety Sensitivity Index is an 18-item scale which measures anxiety sensitivity by asking children to state how aversely they view anxiety symptoms. The child is to mark either "none" (I), "some" (2), or "A Lot" (3) to each item. The child's total anxiety sensitivity score is the sum of his or her points.
measure: Junior Temperament and Character Inventory (JTCI)
time frame: Baseline
description: The Junior Temperament and Character Inventory (JTCI) was developed to assess the temperament ('novelty seeking', 'harm avoidance', 'reward dependence', 'persistence') and character ('self-directedness', 'cooperativeness', 'self-transcendence') dimensions of Cloninger's bio-social model of personality in children and adolescents. Each of the 108 statements can be answered "True" or "False". The parent is to decide which choice best fits the child they are describing in this questionnaire.
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
time frame: Baseline
description: The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a semi-structured interview aimed at early diagnosis of affective disorders such as depression, bipolar disorder, and anxiety disorder. There are currently four different versions of the test that are structured to include interviews with both the child and the parents or guardians.
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
time frame: Week 4 Follow Up
description: The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a semi-structured interview aimed at early diagnosis of affective disorders such as depression, bipolar disorder, and anxiety disorder. There are currently four different versions of the test that are structured to include interviews with both the child and the parents or guardians.
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
time frame: Week 8 Follow Up
description: The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a semi-structured interview aimed at early diagnosis of affective disorders such as depression, bipolar disorder, and anxiety disorder. There are currently four different versions of the test that are structured to include interviews with both the child and the parents or guardians.
measure: Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
time frame: 12 month Follow Up
description: The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a semi-structured interview aimed at early diagnosis of affective disorders such as depression, bipolar disorder, and anxiety disorder. There are currently four different versions of the test that are structured to include interviews with both the child and the parents or guardians.
arm group label: Device Group
arm group type: Experimental
description: The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a portable home device used for breathing biofeedback in adults with PD. FBS has now received FDA clearance for the treatment of PD adults and is currently commercially available and more than 150 therapist have provided the service nationally. However, FBS has not yet been tested for efficacy in a pediatric populations. Due to its portability, FBS may pose an advantage for use in younger age groups, compared to multiple therapy sessions required for CBT or lower acceptability for long-term medication use for adolescent PD. In this pilot intervention study, the efficacy of the FBS system in youth will be tested.
arm group label: Control Group
arm group type: No Intervention
description: The device will be given to those in the control group after 8-week baseline period.
intervention type: Device
intervention name: Freespira Breathing System
description: Over an 8-week period the efficacy of the FBS system in youth will be tested, with those in the randomized active device group. The control group will not receive the device until completion of the 8 week baseline.
arm group label: Device Group
criteria: 
gender: All
minimum age: 9 Years
maximum age: 17 Years
healthy volunteers: No
last name: Marco Grados, M.D., M.P.H.
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anxiety Disorders
mesh term: Panic Disorder
sharing ipd: No
provided document: 
provided document: 