Heart Rate Variability Biofeedback in Young People With Autism

NCT04955093 | Completed

• 2 other identifiers: IRAS13912215/NI/0255
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Biofeedback is a process that allows people to obtain information about their internal physiological reactions and thereby learn to control them. Researchers studying the brain and nervous system have found that regulating heart rate can help us to relax. Controlling heart rate using biofeedback has been shown in some studies to help people manage symptoms of stress such as anxiety and depression. This research will explore whether biofeedback can help people with autism or Asperger syndrome reduce reported symptoms of stress. Participants with a diagnosis of high functioning autism will be invited to use a biofeedback device that helps them to regulate their heart rate. People who enrol for the study will be randomly assigned different biofeedback devices. Training and support in the use of the device will be provided to participants. Assessment will involve obtaining questionnaire reports from participants and their carers about participant levels of anxiety, depression and sensory symptoms, demographics and lifestyle. These assessments will be carried out at the beginning, in the middle and at the end of the study to see if there are any differences in how each participant's heart rate changes, whether there are any changes in participant's reported symptoms. Participants will be asked to give daily reports on their progress to monitor stress levels, usability of device and dropout rates. The overall aim is to determine whether biofeedback is a way of helping people with autism to reduce symptoms of stress.

Conditions

Autistic Disorders Spectrum

Outcome Measures

Primary Outcomes (1)

• Reduction in Anxiety Scale using Beck Youth Inventory

  10-15 minute Questionnaire

  At baseline, after six weeks and at end-point at 12 weeks

Secondary Outcomes (1)

• Any change in Heart rate variability (ideally key metrics increased)

  At baseline, after six weeks and at end-point at 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Device: Biofeedback

Control

NO INTERVENTION

Interventions

Biofeedback DEVICE

Technology to provide Heart Rate Variability Biofeedback

Intervention

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Confirmed diagnosis of High functioning autism / Asperger's syndrome using standardized tests (ADOS / ADI / DISCO), IQ over 70, English speaker Existing or previous client resident within South Eastern Health \& Social Care Trust catchment area.

You may not qualify if:

• Learning disability (IQ\<70). Cardiac condition / pacemaker. Drug /alcohol addiction Current psychosis Current suicidal ideation. Eczema / psoriasis Immunosuppressing condition MRSA / C Difficile

Sponsors & Collaborators

• University of Ulster: lead
• South Eastern Health and Social Care Trust: collaborator

Study Sites (1)

South Eastern Health Trust

Belfast, Northern Ireland, BT37 0QB, United Kingdom

Location

Related Publications (1)

• Coulter H, Donnelly M, Mallett J, Kernohan WG. Heart Rate Variability Biofeedback to Treat Anxiety in Young People With Autism Spectrum Disorder: Findings From a Home-Based Pilot Study. JMIR Form Res. 2022 Aug 26;6(8):e37994. doi: 10.2196/37994.

  PMID: 36018712 DERIVED

MeSH Terms

Conditions

Child Development Disorders, Pervasive

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

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

Model Details: Feasibility study to test out methodology prior to any future large scale trial. It involves a detailed follow up of a clinical sample of people with highfunctioning autism, using repeated measures in a randomized control experimental design. Intervention participants will be given a biofeedback device and training immediately, whilst the control group will wait 6 weeks and then receive the intervention. This will help to increase participation and maximize the detailed data collection that is required

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: July 8, 2021
• Study Start: May 30, 2016
• Primary Completion: August 9, 2017
• Study Completion: August 9, 2017
• Last Updated: July 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)