Biofeedback Intervention in Adolescents With Autism Spectrum Disorder
Evaluating the Potential of Respiratory-sinus-arrhythmia Biofeedback for Reducing Physiological Stress in Adolescents With Autism: a Randomized Controlled Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Anoushka Thoen
- Phone Number: 0498628643
- Email: anoushka.thoen@kuleuven.be
Study Locations
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Vlaams Brabant
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Leuven, Vlaams Brabant, Belgium, 3000
- KU Leuven
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written informed consent/assent
- Male/female
- 13-18 years old
- For adolescents with ASD only: Confirmed ASD-diagnosis (DSM-IV/V)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Supervised RSA biofeedback
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.
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Biofeedback intervention based on breathing at resonance frequency
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Sham Comparator: Supervised sham RSA biofeedback
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.
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Biofeedback intervention based on breathing at resonance frequency
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Experimental: Non-supervised RSA biofeedback
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.
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Biofeedback intervention based on breathing at resonance frequency
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No Intervention: No intervention
No intervention is given.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Root Mean Square of Successive Differences between normal heart beats (RMSSD) as a measure of cardiac vagal modulation.
Time Frame: At all assessment points: before supervised intervention (baseline) + after 5 weeks supervised intervention + after 5 weeks follow-up
|
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).
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At all assessment points: before supervised intervention (baseline) + after 5 weeks supervised intervention + after 5 weeks follow-up
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Change in Logarithm of High-Frequency Heart Rate Variability (LnHF-HRV) as a measure of cardiac vagal modulation.
Time Frame: At all assessment points: before supervised intervention (baseline) + after 5 weeks supervised intervention + after 5 weeks follow-up
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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).
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At all assessment points: before supervised intervention (baseline) + after 5 weeks supervised intervention + after 5 weeks follow-up
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Heart rate
Time Frame: 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
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Physiological assessment of heart rate by using a ECG-monitoring with 3 electrodes placed on the chest.
The unit measure will be expressed in beats per minute.
The sensors and biofeedback device from 'nexus-10' will be used in combination with 'biotrace+' software.
This measurement will be repeated 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).
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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
|
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Change in Breathing frequency
Time Frame: 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
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Physiological assessment of the breathing pattern by using an elastic band with stretch-sensitive sensors around the waist.
The unit measure will be expressed in breaths per minute.
The sensors and biofeedback device from 'nexus-10' will be used in combination with 'biotrace+' software.
This measurement will be repeated 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).
|
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
|
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Change in Skin conductance
Time Frame: 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
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Physiological assessment of skin conductance by placing one sensor on the palmar side of the index finger and 1 on the palmar side of the ring finger.
The unit measure will be expressed in Micro Siemen.
The sensors and biofeedback device from 'nexus-10' will be used in combination with 'biotrace+' software.
This measurement will be repeated 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).
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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
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Change in Fingertip temperature
Time Frame: 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
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Physiological assessment of the temperature of the fingertip by attaching a temperature sensor on the palmar side of the middle finger.
The unit measure will be expressed in Degrees Celsius.The sensors and biofeedback device from 'nexus-10' will be used in combination with 'biotrace+' software.
This measurement will be repeated 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).
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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
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Change in Cortisol level
Time Frame: 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
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Endogenic measurement of cortisol level in saliva samples (3 times during assessment procedure for both adolescent groups, with and without autism spectrum disorder).
These 3 measurements will be repeated at multiple assessment points (only for adolescents with autism spectrum disorder).
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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
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Autism Spectrum Quotient - Adolescent Version (AQ)
Time Frame: At baseline assessment (typically developing adolescents + adolescents with autism spectrum disorder)
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Identifies the extent of autistic traits shown by a person of normal intelligence based on parent-report.
The scale's total score can vary between 0 and 50 in which a higher score means a higher presence of symptoms related to the autism spectrum.
A cut-off of 32 is used for the in- or exclusion of typically developing adolescents.
This measure will only be used once in both adolescent groups (with and without autism spectrum disorder).
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At baseline assessment (typically developing adolescents + adolescents with autism spectrum disorder)
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Change on Social Responsiveness Scale - 2nd edition (SRS-2)
Time Frame: At baseline assessment (typically developing adolescents + adolescents with autism spectrum disorder) + after follow-up phase at the end of the trial (adolescents with autism spectrum disorder)
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A quantitative assessment of the severity of autism traits during the past six months in children based on parent-report.
This questionnaire identifies social impairment associated with ASD and quantifies its severity by using 5 subscales (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior).
The total score can vary between 65 and 260.
These scores are related to t-values from the questionnaires manual.
Higher scores are related to a higher level of impairment.
Change in score for this outcome measure is only measured in adolescents with autism spectrum disorder.
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At baseline assessment (typically developing adolescents + adolescents with autism spectrum disorder) + after follow-up phase at the end of the trial (adolescents with autism spectrum disorder)
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Change on Repetitive Behavior Scale - Revised (RBS-R)
Time Frame: At baseline assessment (typically developing adolescents + adolescents with autism spectrum disorder) + after follow-up phase at the end of the trial (adolescents with autism spectrum disorder)
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Scores the number and intensity of repetitive and restrictive behaviors of the past month in children based on parent-report.
The scale's maximum score varies between 0 and 129 with higher scores relating to a higher presence of repetitive and restrictive behaviors.
These behaviors are additionally categorised in 6 categories: Stereotyped Behavior; Self-injurious Behavior; Compulsive Behavior; Ritualistic Behavior; Sameness Behavior.
Parent are also asked to rate the impact of these behaviors on daily functioning on a scale from 0 (meaning no interference with daily life) and 100 (extremely problematic related to functioning in daily life).
Change in score for this outcome measure is only measured in adolescents with autism spectrum disorder.
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At baseline assessment (typically developing adolescents + adolescents with autism spectrum disorder) + after follow-up phase at the end of the trial (adolescents with autism spectrum disorder)
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Change on Strengths and Difficulties Questionnaire - parent report (SDQ-PR)
Time Frame: At baseline assessment (typically developing adolescents + adolescents with autism spectrum disorder) + after follow-up phase at the end of the trial (adolescents with autism spectrum disorder)
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A brief behavioral screen in which parents need to rate the presence of certain behaviors in their child during the past six months or during the past academic year.
There are 5 categories of behavioral problems: emotional problems, conduct problems, hyperactivity, peer problems and prosocial behavior.
The scale's total score varies between 0 and 40 with higher values indicating more behavioral problems and consists of the summation of all scales except the prosocial scale score.
Change in score for this outcome measure is only measured in adolescents with autism spectrum disorder.
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At baseline assessment (typically developing adolescents + adolescents with autism spectrum disorder) + after follow-up phase at the end of the trial (adolescents with autism spectrum disorder)
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Change on Strengths and Difficulties Questionnaire - adolescent self-report (SDQ-SR)
Time Frame: At baseline assessment (typically developing adolescents + adolescents with autism spectrum disorder) + after follow-up phase at the end of the trial (adolescents with autism spectrum disorder)
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A brief behavioral screen to rate the presence of certain behaviors during the past six months, based on adolescent self-report.
There are 5 categories of behavioral problems: emotional problems, conduct problems, hyperactivity, peer problems and prosocial behavior.
The scale's total score varies between 0 and 40 with higher values indicating more behavioral problems and consists of the summation of all scales except the prosocial scale score.
Change in score for this outcome measure is only measured in adolescents with autism spectrum disorder.
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At baseline assessment (typically developing adolescents + adolescents with autism spectrum disorder) + after follow-up phase at the end of the trial (adolescents with autism spectrum disorder)
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Change on Perceived Stress Scale - Adolescent version (PSS)
Time Frame: 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
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Measures the degree to which situations in the adolescent's life are appraised as stressful, that is, how unpredictable, uncontrollable, and overloaded respondents find their lives.
This measure is based on adolescent self-report and items are adapted according to the specific problems adolescents can encounter in their lives such as school-related stress.
The scale's total score varies between 0 and 40 in which higher scores relate to higher perceived stress levels.
Change in score for this outcome measure is only measured in adolescents with autism spectrum disorder.
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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
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Change on Depression Anxiety and Stress Scale-21 items version
Time Frame: 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
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Measures the presence of symptoms of depression, anxiety and stress based on adolescent self-report.
The scale's total score varies between 0 and 63 in which higher scores relate to a higher presence of symptoms.
Separate scale scores are calculated for symptoms related to depression, anxiety and stress.
Change in score for this outcome measure is only measured in adolescents with autism spectrum disorder.
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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
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Change on Physical Activity Vital Sign
Time Frame: 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
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Measures the level of physical activity of the last week based on adolescent self-report.
This measures consists of two short questions related to (1) the amount of days the adolescent was physically active and (2) the amount of minutes (on average) this psychical activity was endured.
Change in score for this outcome measure is only measured in adolescents with autism spectrum disorder.
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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
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Change on Visual Analogue Scale (VAS) for sensory hyper-responsivity
Time Frame: 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
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Measures the self-reported impact of sensory hyper-responsivity of the adolescent on a Visual Analogue Scale going from 0 (meaning no perceived sensory hyper-responsivity) to 100 (meaning presence of severe sensory hyper-responsivity and negative impact on functioning).
Change in score for this outcome measure is only measured in adolescents with autism spectrum disorder.
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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
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Change on Visual Analogue Scale for perceived stress
Time Frame: 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
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To rate the self-reported perceived stress-level of the adolescent on a Visual Analogue Scale per stressor during the stress-inducing test.
The scale score can vary between 0 (meaning no stress) and 100 (meaning highest level of perceived stress possible).
Change in score for this outcome measure is only measured in adolescents with autism spectrum disorder.
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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
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Tine Van Damme, Professor, KU Leuven
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- s64219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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