Relaxation Breathing Training for Children

NCT03271086 | Withdrawn

• 1 other identifier: H-36659
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorder; Biofeedback

Keywords

Relaxation training; Pediatric clinic; Children 6-11 years; Text messaging

Outcome Measures

Primary Outcomes (1)

• 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.

  daily for 4 weeks

Secondary Outcomes (2)

• Parenting Stress Index Short Form (PSI-SF)

  one month follow up

• Spence Children's Anxiety Scale (SCAS)

  one month follow up

Study Arms (2)

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.

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.

Behavioral: The StressEraser; Behavioral: Breathe2Relax; Behavioral: Reminder text messages

Interventions

The StressEraser BEHAVIORAL

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.

Relaxation breathing training; Technology-enhanced relaxation breathing

Breathe2Relax BEHAVIORAL

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.

Technology-enhanced relaxation breathing

Reminder text messages BEHAVIORAL

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.

Technology-enhanced relaxation breathing

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Naomi Steiner, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 1, 2017
• Study Start: October 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)