<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/NCT03271086</url>
  </required_header>
  <id_info>
    <org_study_id>H-36659</org_study_id>
    <nct_id>NCT03271086</nct_id>
  </id_info>
  <brief_title>Relaxation Breathing Training for Children</brief_title>
  <official_title>Family Centered Relaxation Breathing Training in the Pediatrics Outpatient Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Medical Center</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>
      Family-centered Relaxation Breathing Training in the Pediatric Outpatient Clinic:&#xD;
&#xD;
      The long term goal is to apply simple, low cost, assistive technologies (heart rate&#xD;
      variability [HRV] biofeedback together with mobile health tools) to teach relaxation&#xD;
      breathing in the Boston Medical Center pediatric clinic setting following a trauma-informed&#xD;
      care model. For this research both a mobile app for relaxation breathing skills and reminder&#xD;
      text messages will be provided for the at-risk target population. The investigators will&#xD;
      assess the feasibility and acceptability of relaxation breathing intervention in 60&#xD;
      parent-child dyads. These dyads will be randomly assigned to receive either (1) biofeedback&#xD;
      relaxation training alone or (2) Technology-enhanced relaxation breathing (biofeedback&#xD;
      relaxation training together with mobile health tools). Outcome measures will assess&#xD;
      relaxation breathing practice, anxiety, and parental stress at the time of the intervention&#xD;
      and at one month follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After consent is signed, a baseline questionnaire will be given to the participant, including&#xD;
      demographics and baseline data followed by randomization into one of the following&#xD;
      groups:Relaxation breathing training alone or Technology-enhanced relaxation breathing.The&#xD;
      intervention will occur through the use of the StressEraser, Breathe2Relax and text&#xD;
      messaging.&#xD;
&#xD;
        1. The StressEraser is a handheld biofeedback device that measures heart rate variability&#xD;
           (HRV). Heart rate increases during inspiration and decreases during expiration. This&#xD;
           HRV, depicted on a miniature screen, essentially represents respirations. We have been&#xD;
           using this device in the pediatric outpatient department over the past two years (in a&#xD;
           non research entity) and it has been well accepted by children 6 years of age and above.&#xD;
           In our prior study, which took place in school, the device was also easily mastered and&#xD;
           acceptable to children above 6 years of age.&#xD;
&#xD;
        2. Breathe2Relax is a free mobile app, developed by the Dept. of Defense's National Center&#xD;
           for Telehealth and Technology to help veterans with PTSD and others use breathing&#xD;
           practice for stress management. This application guides users in relaxation breathing&#xD;
           and is available for both android and iOS phones. It is adapted for children 6 years and&#xD;
           up. The user downloads the app. and is walked through steps that easily explain the&#xD;
           purpose of the app (to guide relaxation breathing). The active part of the app shows a&#xD;
           tube that fills in during inspiration and empties during expiration. For children the&#xD;
           cycle lengths can be shortened which is explained to participating parents by the&#xD;
           research team. There is a selection of quiet music and the user can choose backgrounds&#xD;
           for personalization. The Breath2Relax app will be downloaded for the RT-enhanced group&#xD;
           at the time of the intervention for the RT-enhanced group, and the parent will be shown&#xD;
           how to modify the length of the breath cycle depending on their child's age.&#xD;
&#xD;
        3. Text messages: Weekly texts will be sent out to parents in the RT-enhanced group&#xD;
           regarding relaxation breathing and to remind parents to practice the daily relaxation&#xD;
           breathing with their child.&#xD;
&#xD;
      For the breathing training, the study research assistant (RA) will follow the standardized&#xD;
      protocol used in BMC pediatric clinic over the past two years. The child is taught firstand&#xD;
      learns how to use relaxation breathing and then the child teaches their parent how it works&#xD;
      with the support of the RA. This step assures that the child has learned the relaxation&#xD;
      breathing skills and also creates a moment when relaxation breathing is practiced together by&#xD;
      the dyad. The parent-child dyad are encouraged to practice relaxation breathing once&#xD;
      daily.Caregivers usually choose bedtime to practice breathing because the practice can be&#xD;
      done while the child is in bed.&#xD;
&#xD;
      The training is followed for the Technology-enhanced relaxation breathing group by&#xD;
      downloading the Breath2Relax app on the parent's smartphone. Parents will be prompted by the&#xD;
      RA to choose a specific time each day to practice the relaxation breathing with their child,&#xD;
      and for the Technology-enhanced relaxation breathing group using the Breath2Relax app.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study was never started.&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fidelity to daily relaxation breathing</measure>
    <time_frame>daily for 4 weeks</time_frame>
    <description>Fidelity to the daily relaxation breathing will be captured from information recorded by the parent in a dairy this will be provided at the end of the relaxation training. They will be instructed to record the number of times daily that they and their child do the relaxation breathing exercises. Data will be entered by the research team 4 weeks post training and the number of times/total number of days post training for each parent and child will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parenting Stress Index Short Form (PSI-SF)</measure>
    <time_frame>one month follow up</time_frame>
    <description>The PSI-SF is a questionnaire that contains 36 statements written at a 5th-grade reading level, for parents of children 12 years and younger. The PSI/SF yields a Total Stress score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The total score is read from percentiles and the 16th - 84th Percentile = Normal range, 85th - 89th Percentile = High range, 90th Percentile or higher = Clinically significant range for parental stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spence Children's Anxiety Scale (SCAS)</measure>
    <time_frame>one month follow up</time_frame>
    <description>SCAS is a 39 item instrument completed by the parent but only the first 38 items are scored.The parent selects one of the following four responses to the first 38 items: never=0, sometimes=1, often=2, or always=3. Scores can range from 0 to 114 and the higher the score the more anxiety the child has. The 39th item asks the parent if their child is afraid of anything else with a yes or no response; it is not scored..</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Stress Disorder</condition>
  <condition>Biofeedback</condition>
  <arm_group>
    <arm_group_label>Relaxation breathing training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dyads of a parent and their child in this group will receive training on how to use breathing to relax with the StressEraser in the pediatric clinic and will then practice the breathing for about 4 weeks They will also complete a baseline questionnaire and two questionnaires one month after the training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Technology-enhanced relaxation breathing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dyads of a parent and their child in this group will receive technology-enhanced training on how to use breathing to relax with the StressEraser and the app Breathe2Relax in the pediatric clinic and will then practice the breathing for about 4 weeks and weekly receive weekly reminder text messages to practice their relaxation breathing. They will also complete a baseline questionnaire and two questionnaires one month after the training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The StressEraser</intervention_name>
    <description>The StressEraser is a handheld biofeedback device that measures heart rate variability (HRV). Heart rate increases during inspiration and decreases during expiration. The HRV, depicted on a miniature screen, essentially represents respirations. The investigator's prior study demonstrated that the device is easily mastered and acceptable to children above 6 years of age.</description>
    <arm_group_label>Relaxation breathing training</arm_group_label>
    <arm_group_label>Technology-enhanced relaxation breathing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breathe2Relax</intervention_name>
    <description>Breathe2Relax is a free mobile app, developed by the Dept. of Defense's National Center for Telehealth and Technology to help veterans with PTSD and others use breathing practice for stress management. This application guides users in relaxation breathing and is available for both android and iOS phones. It is adapted for children 6 years and up. For instance, the cycles can be shortened for children, there is a selection of quiet music and the user can choose backgrounds for personalization.</description>
    <arm_group_label>Technology-enhanced relaxation breathing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reminder text messages</intervention_name>
    <description>Weekly texts will be sent out to parents in the technology-enhanced relaxation breathing group to as reminders to practice the daily relaxation breathing with their child.</description>
    <arm_group_label>Technology-enhanced relaxation breathing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  child between 6 and 11 years of age and their parent&#xD;
&#xD;
          -  primary language either English or Spanish&#xD;
&#xD;
          -  parent has a working smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a child who is in Department of Children and Families (DCF) custody whose caregiver is&#xD;
             a foster parent&#xD;
&#xD;
          -  parent who does not speak or read English or Spanish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naomi Steiner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</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>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>November 15, 2020</last_update_submitted>
  <last_update_submitted_qc>November 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Relaxation training</keyword>
  <keyword>Pediatric clinic</keyword>
  <keyword>Children 6-11 years</keyword>
  <keyword>Text messaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</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/NCT03271086
org study id: H-36659
nct id: NCT03271086
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Family-centered Relaxation Breathing Training in the Pediatric Outpatient Clinic:

      The long term goal is to apply simple, low cost, assistive technologies (heart rate
      variability [HRV] biofeedback together with mobile health tools) to teach relaxation
      breathing in the Boston Medical Center pediatric clinic setting following a trauma-informed
      care model. For this research both a mobile app for relaxation breathing skills and reminder
      text messages will be provided for the at-risk target population. The investigators will
      assess the feasibility and acceptability of relaxation breathing intervention in 60
      parent-child dyads. These dyads will be randomly assigned to receive either (1) biofeedback
      relaxation training alone or (2) Technology-enhanced relaxation breathing (biofeedback
      relaxation training together with mobile health tools). Outcome measures will assess
      relaxation breathing practice, anxiety, and parental stress at the time of the intervention
      and at one month follow up.
After consent is signed, a baseline questionnaire will be given to the participant, including
      demographics and baseline data followed by randomization into one of the following
      groups:Relaxation breathing training alone or Technology-enhanced relaxation breathing.The
      intervention will occur through the use of the StressEraser, Breathe2Relax and text
      messaging.

        1. The StressEraser is a handheld biofeedback device that measures heart rate variability
           (HRV). Heart rate increases during inspiration and decreases during expiration. This
           HRV, depicted on a miniature screen, essentially represents respirations. We have been
           using this device in the pediatric outpatient department over the past two years (in a
           non research entity) and it has been well accepted by children 6 years of age and above.
           In our prior study, which took place in school, the device was also easily mastered and
           acceptable to children above 6 years of age.

        2. Breathe2Relax is a free mobile app, developed by the Dept. of Defense's National Center
           for Telehealth and Technology to help veterans with PTSD and others use breathing
           practice for stress management. This application guides users in relaxation breathing
           and is available for both android and iOS phones. It is adapted for children 6 years and
           up. The user downloads the app. and is walked through steps that easily explain the
           purpose of the app (to guide relaxation breathing). The active part of the app shows a
           tube that fills in during inspiration and empties during expiration. For children the
           cycle lengths can be shortened which is explained to participating parents by the
           research team. There is a selection of quiet music and the user can choose backgrounds
           for personalization. The Breath2Relax app will be downloaded for the RT-enhanced group
           at the time of the intervention for the RT-enhanced group, and the parent will be shown
           how to modify the length of the breath cycle depending on their child's age.

        3. Text messages: Weekly texts will be sent out to parents in the RT-enhanced group
           regarding relaxation breathing and to remind parents to practice the daily relaxation
           breathing with their child.

      For the breathing training, the study research assistant (RA) will follow the standardized
      protocol used in BMC pediatric clinic over the past two years. The child is taught firstand
      learns how to use relaxation breathing and then the child teaches their parent how it works
      with the support of the RA. This step assures that the child has learned the relaxation
      breathing skills and also creates a moment when relaxation breathing is practiced together by
      the dyad. The parent-child dyad are encouraged to practice relaxation breathing once
      daily.Caregivers usually choose bedtime to practice breathing because the practice can be
      done while the child is in bed.

      The training is followed for the Technology-enhanced relaxation breathing group by
      downloading the Breath2Relax app on the parent's smartphone. Parents will be prompted by the
      RA to choose a specific time each day to practice the relaxation breathing with their child,
      and for the Technology-enhanced relaxation breathing group using the Breath2Relax app.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Fidelity to daily relaxation breathing
time frame: daily for 4 weeks
description: Fidelity to the daily relaxation breathing will be captured from information recorded by the parent in a dairy this will be provided at the end of the relaxation training. They will be instructed to record the number of times daily that they and their child do the relaxation breathing exercises. Data will be entered by the research team 4 weeks post training and the number of times/total number of days post training for each parent and child will be calculated.
measure: Parenting Stress Index Short Form (PSI-SF)
time frame: one month follow up
description: The PSI-SF is a questionnaire that contains 36 statements written at a 5th-grade reading level, for parents of children 12 years and younger. The PSI/SF yields a Total Stress score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The total score is read from percentiles and the 16th - 84th Percentile = Normal range, 85th - 89th Percentile = High range, 90th Percentile or higher = Clinically significant range for parental stress.
measure: Spence Children's Anxiety Scale (SCAS)
time frame: one month follow up
description: SCAS is a 39 item instrument completed by the parent but only the first 38 items are scored.The parent selects one of the following four responses to the first 38 items: never=0, sometimes=1, often=2, or always=3. Scores can range from 0 to 114 and the higher the score the more anxiety the child has. The 39th item asks the parent if their child is afraid of anything else with a yes or no response; it is not scored..
arm group label: Relaxation breathing training
arm group type: Experimental
description: Dyads of a parent and their child in this group will receive training on how to use breathing to relax with the StressEraser in the pediatric clinic and will then practice the breathing for about 4 weeks They will also complete a baseline questionnaire and two questionnaires one month after the training.
arm group label: Technology-enhanced relaxation breathing
arm group type: Experimental
description: Dyads of a parent and their child in this group will receive technology-enhanced training on how to use breathing to relax with the StressEraser and the app Breathe2Relax in the pediatric clinic and will then practice the breathing for about 4 weeks and weekly receive weekly reminder text messages to practice their relaxation breathing. They will also complete a baseline questionnaire and two questionnaires one month after the training.
intervention type: Behavioral
intervention name: The StressEraser
description: The StressEraser is a handheld biofeedback device that measures heart rate variability (HRV). Heart rate increases during inspiration and decreases during expiration. The HRV, depicted on a miniature screen, essentially represents respirations. The investigator's prior study demonstrated that the device is easily mastered and acceptable to children above 6 years of age.
arm group label: Relaxation breathing training
arm group label: Technology-enhanced relaxation breathing
intervention type: Behavioral
intervention name: Breathe2Relax
description: Breathe2Relax is a free mobile app, developed by the Dept. of Defense's National Center for Telehealth and Technology to help veterans with PTSD and others use breathing practice for stress management. This application guides users in relaxation breathing and is available for both android and iOS phones. It is adapted for children 6 years and up. For instance, the cycles can be shortened for children, there is a selection of quiet music and the user can choose backgrounds for personalization.
arm group label: Technology-enhanced relaxation breathing
intervention type: Behavioral
intervention name: Reminder text messages
description: Weekly texts will be sent out to parents in the technology-enhanced relaxation breathing group to as reminders to practice the daily relaxation breathing with their child.
arm group label: Technology-enhanced relaxation breathing
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: No
last name: Naomi Steiner, MD
role: Principal Investigator
affiliation: Boston Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
sharing ipd: No