Clinical trial NCT03271086: Relaxation Breathing Training for Children
Official title: Family Centered Relaxation Breathing Training in the Pediatrics Outpatient Clinic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stress Disorder
Biofeedback
Keywords: Relaxation training
Pediatric clinic
Children 6-11 years
Text messaging
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Fidelity to daily relaxation breathing
timeFrame: daily for 4 weeks
Secondary outcomes:
measure: Parenting Stress Index Short Form (PSI-SF)
timeFrame: one month follow up
measure: Spence Children's Anxiety Scale (SCAS)
timeFrame: one month follow up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Naomi Steiner, MD
role: PRINCIPAL_INVESTIGATOR
References: