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Relaxation Breathing Training for Children

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ClinicalTrials.gov Identifier: NCT03271086
Recruitment Status : Withdrawn (The study was never started.)
First Posted : September 1, 2017
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stress Disorder Biofeedback Behavioral: The StressEraser Behavioral: Breathe2Relax Behavioral: Reminder text messages Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Family Centered Relaxation Breathing Training in the Pediatrics Outpatient Clinic
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Relaxation breathing training
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.
Behavioral: The StressEraser
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.

Experimental: Technology-enhanced relaxation breathing
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.
Behavioral: The StressEraser
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.

Behavioral: Breathe2Relax
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.

Behavioral: Reminder text messages
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.




Primary Outcome Measures :
  1. Fidelity to daily relaxation breathing [ Time Frame: daily for 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Parenting Stress Index Short Form (PSI-SF) [ Time Frame: one month follow up ]
    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.

  2. Spence Children's Anxiety Scale (SCAS) [ Time Frame: one month follow up ]
    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..



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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • child between 6 and 11 years of age and their parent
  • primary language either English or Spanish
  • parent has a working smartphone

Exclusion Criteria:

  • a child who is in Department of Children and Families (DCF) custody whose caregiver is a foster parent
  • parent who does not speak or read English or Spanish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271086


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Naomi Steiner, MD Boston Medical Center
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT03271086    
Other Study ID Numbers: H-36659
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
Relaxation training
Pediatric clinic
Children 6-11 years
Text messaging
Additional relevant MeSH terms:
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Respiratory Aspiration
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes