Stress DisorderNCT03271086
Relaxation Breathing Training for Children
A study testing The StressEraser, Breathe2Relax and Reminder text messages in people with Stress Disorder and Biofeedback, run by Boston Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Stress Disorder, Biofeedback
- What is being tested?
- The StressEraser, Breathe2Relax and Reminder text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child between 6 and 11 years of age and their parent
- primary language either English or Spanish
- parent has a working smartphone
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family Centered Relaxation Breathing Training in the Pediatrics Outpatient Clinic
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.
Read the 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.
- 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.
- 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.
- 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.
- Conditions
- Stress Disorder, Biofeedback
- Being tested
- The StressEraser, Breathe2Relax, Reminder text messages
- Keywords
- Relaxation training, Pediatric clinic, Children 6-11 years, Text messaging
- Medical subject headings
- Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The StressEraserBehavioural
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.
Breathe2RelaxBehavioural
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.
Reminder text messagesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation breathing training | Experimental | 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. Receives: Behavioral: The StressEraser |
| Technology-enhanced relaxation breathing | Experimental | 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. Receives: Behavioral: The StressEraser; Behavioral: Breathe2Relax; Behavioral: Reminder text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity to daily relaxation breathing
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.
Measured: daily for 4 weeks
Secondary outcomes (2)
Parenting Stress Index Short Form (PSI-SF)
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.
Measured: one month follow up
Spence Children's Anxiety Scale (SCAS)
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..
Measured: one month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study startOct 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: The study was never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naomi Steiner, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271086
- Sponsor's protocol ID
- H-36659
- Status last verified
- Nov 2020
- First submitted
- 31 Aug 2017
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Centered Relaxation Breathing Training in the Pediatrics Outpatient Clinic
- ClinicalTrials.gov ID
- NCT03271086
- Acronym / sponsor ID
- H-36659
- Conditions
- Stress Disorder, Biofeedback
- Keywords
- Relaxation training, Pediatric clinic, Children 6-11 years, Text messaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation breathing training | Experimental | Behavioral: The StressEraserDyads 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. |
| Technology-enhanced relaxation breathing | Experimental | Behavioral: The StressEraser, Behavioral: Breathe2Relax, Behavioral: Reminder text messagesDyads 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- child between 6 and 11 years of age and their parent
- primary language either English or Spanish
- parent has a working smartphone
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The StressEraserThe 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. | Behavioural | Relaxation breathing training, Technology-enhanced relaxation breathing |
| Breathe2RelaxBreathe2Relax 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. | Behavioural | Technology-enhanced relaxation breathing |
| Reminder text messagesWeekly 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. | Behavioural | Technology-enhanced relaxation breathing |
Primary outcome
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.
2 secondary outcomes
Parenting Stress Index Short Form (PSI-SF)
Time frame: one month follow up
Spence Children's Anxiety Scale (SCAS)
Time frame: one month follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Stress Disorder
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
Not yet recruiting
Negotiation Training for Family Caregivers of People With Alzheimer's Disease
Alzheimer's Disease (AD), Dementia
Not yet recruiting
FUS Neuromodulation for PTSD
Post Traumatic Stress Disorder PTSD
Recruiting
Structural Heat Adaptation and Education in Urban Setting
Heat Illness, Quality of Life
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Steiner, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The StressEraser, Breathe2Relax and Reminder text messages in people with Stress Disorder and Biofeedback, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity to daily relaxation breathing (time frame: daily for 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.