Biofeedback Intervention in Adolescents With Autism Spectrum Disorder

NCT04628715 | Terminated

• 1 other identifier: s64219
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study consists of two phases, a cross-sectional and a interventional. The cross-sectional phase will provide more insight into the differences in the autonomic functioning between adolescents with autism spectrum disorder and their typically developing peers. During the longitudinal phase, the efficacy of an RSA biofeedback intervention will be examined in adolescents with autism spectrum disorder.

Conditions

Autism Spectrum Disorder

Keywords

Biofeedback; Stress

Outcome Measures

Primary Outcomes (2)

• Change in Root Mean Square of Successive Differences between normal heart beats (RMSSD) as a measure of cardiac vagal modulation.

  This measure will provide information concerning the cardiac vagal modulation of heart rate based on time domain analysis. This analysis will be performed based on heart rate recordings at multiple assessment timepoints (only for adolescents with autism spectrum disorder). In addition, during one assessment, change will be measured between the different tasks (baseline, stroop word-color interference task, rest, social stress recall task and rest) in both adolescent groups (with and without autism spectrum disorder).

  At all assessment points: before supervised intervention (baseline) + after 5 weeks supervised intervention + after 5 weeks follow-up

• Change in Logarithm of High-Frequency Heart Rate Variability (LnHF-HRV) as a measure of cardiac vagal modulation.

  This measure is an additional primary outcome measure concerning cardiac vagal modulation of heart rate based on frequency domain analysis. This analysis will be performed based on heart rate recordings at multiple assessment points (only for adolescents with autism spectrum disorder). In addition, during one assessment, change will be measured between the different tasks (baseline, stroop word-color interference task, rest, social stress recall task and rest) in both adolescent groups (with and without autism spectrum disorder).

  At all assessment points: before supervised intervention (baseline) + after 5 weeks supervised intervention + after 5 weeks follow-up

Secondary Outcomes (15)

• Change in Heart rate

  Adolescents with autism spectrum disorder: At all assessment points: before supervised intervention (baseline) + after 5 weeks supervised intervention + after 5 weeks follow-up; TD adolescents: baseline only

• Change in Breathing frequency

  Adolescents with autism spectrum disorder: At all assessment points: before supervised intervention (baseline) + after 5 weeks supervised intervention + after 5 weeks follow-up; TD adolescents: baseline only

• Change in Skin conductance

  Adolescents with autism spectrum disorder: At all assessment points: before supervised intervention (baseline) + after 5 weeks supervised intervention + after 5 weeks follow-up; TD adolescents: baseline only

• Change in Fingertip temperature

  Adolescents with autism spectrum disorder: At all assessment points: before supervised intervention (baseline) + after 5 weeks supervised intervention + after 5 weeks follow-up; TD adolescents: baseline only

• Change in Cortisol level

  Adolescents with autism spectrum disorder: At all assessment points: before supervised intervention (baseline) + after 5 weeks supervised intervention + after 5 weeks follow-up; TD adolescents: baseline only

Study Arms (4)

Supervised RSA biofeedback

EXPERIMENTAL

5 weeks with weekly supervised sessions of 30 minutes and daily home practice sessions of 20 minutes. The latter sessions can be divided into four bouts of 5 minutes which can be spread across the day. The main goal during this intervention is to breath at resonance frequency which is slower than the usual breathing frequency. Participants will be guided towards this lower breathing frequency by using appropriate breathing techniques and the provision of a breathing pacer during the supervised sessions. During home practice, the participants will be provided with an application which will visualise a breathing pacer at their resonance frequency. At the third session, participants will no longer receive a breathing pacer but are instructed to breath in phase with their heart rate which is visualised on the computer screen instead of the breathing pacer.

Device: RSA biofeedback

Supervised sham RSA biofeedback

SHAM COMPARATOR

5 weeks with weekly supervised sessions of 30 minutes and daily home practice sessions of 20 minutes. The latter sessions can be divided into four bouts of 5 minutes which can be spread across the day. The sham-control treatment will follow the same steps as outlined in the supervised intervention arm. However, the participants in this control group will not receive any information regarding their own heart rate and they will not practice at their resonance frequency. Instead, a default mode will be shown during the sessions and in their application for home practice.

Device: RSA biofeedback

Non-supervised RSA biofeedback

EXPERIMENTAL

1 short guided session (30 minutes) and daily practice (20 minutes; 4 bouts of 5 minutes) for 5 weeks. The biofeedback protocol will be provided by an application, similar to the supervised protocol but without guidance throughout the sessions, except for the first session. During this first session, the information will be provided about the application and the heart rate sensor (Polar band) which will detect changes in heart rate during the training. In addition, the resonance frequency of the participant will be determined so they can practice breathing at this frequency for the next 5 weeks.

Device: RSA biofeedback

No intervention

NO INTERVENTION

No intervention is given.

Interventions

RSA biofeedback DEVICE

Biofeedback intervention based on breathing at resonance frequency

Non-supervised RSA biofeedback; Supervised RSA biofeedback; Supervised sham RSA biofeedback

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Written informed consent/assent
• Male/female
• years old
• For adolescents with ASD only: Confirmed ASD-diagnosis (DSM-IV/V)

You may not qualify if:

• Presence of intellectual disability (DSM-IV/V)
• Hearing- or vision impairment without appropriate correction
• Presence of congenital heart diseases, diagnosed cardiovascular abnormalities or somatic diseases
• Pregnancy
• Insufficient knowledge of Dutch language
• Participation in other Clinical Trial(s)
• For typically developing adolescents only: Presence of neurodevelopmental disorder or psychiatric disorder (DSM-IV/V) + Presence of a sibling with a neurodevelopmental disorder (DSM-IV/V)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Publications (2)

• Thoen A, Alaerts K, Prinsen J, Steyaert J, Van Damme T. The Physiological and Clinical-Behavioral Effects of Heart Rate Variability Biofeedback in Adolescents with Autism: A Pilot Randomized Controlled Trial. Appl Psychophysiol Biofeedback. 2024 Sep;49(3):419-438. doi: 10.1007/s10484-024-09638-1. Epub 2024 Mar 15.

  PMID: 38491260 DERIVED

• Thoen A, Steyaert J, Alaerts K, Van Damme T. Evaluating the potential of respiratory-sinus-arrhythmia biofeedback for reducing physiological stress in adolescents with autism: study protocol for a randomized controlled trial. Trials. 2021 Oct 21;22(1):730. doi: 10.1186/s13063-021-05709-4.

  PMID: 34674737 DERIVED

Related Links

• Information on research project on the Leuven Autism Research group webpage

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Tine Van Damme, Professor

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are two intervention phases, a supervised intervention and a feasibility study for a non-supervised intervention (during the follow-up phase after the supervised intervention). During the supervised intervention (5weeks), participant will be randomly allocated to the RSA biofeedback intervention (1) or a sham-control intervention (2). Then a 5-week follow-up phase is included during which the feasibility study of a non-supervised RSA biofeedback intervention will take place. The two groups from the supervised intervention will each be split into two (a and b) where groups 1a and 2a will receive a non-supervised biofeedback intervention and groups 1b and 2b will receive no intervention. Allocation to groups a and b is also ad random. Important to note: only during the supervised intervention, blinding of participants is possible whereas during the non-supervised intervention, this is not feasible.

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 13, 2020
• Study Start: November 26, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: March 30, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)