Heart Rate Variability Biofeedback for Anxiety in Autistic Youth

ConditionsAutism Spectrum Disorder Anxiety

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age12-17

SponsorMassachusetts General Hospital

About this trial

Heart rate variability biofeedback (HRVB) is a breathing-based intervention that reduces anxiety in a range of populations. Second-generation wearable HRVB devices not only deliver scheduled biofeedback practice sessions but also allow patients to practice HRVB in-the-moment when it is needed most. This study is testing the acceptability, feasibility, and preliminary efficacy of second-generation, ambulatory HRVB for the treatment of anxiety in autistic youth.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 12-17 years at the time of enrollment.

ASD diagnosis from a qualified health professional based on medical records and confirmed based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria by the study clinician.

IQ ≥50 based on the Kaufman Brief Intelligence Test (KBIT-2).

Clinically significant anxiety, based on the Pediatric Anxiety Rating Scale (PARS) 5-item score of ≥10.

Disqualifiers

Clinically significant cardiac arrhythmia based on parent report.

Current primary diagnosis of bipolar disorder, psychosis, substance use disorder, posttraumatic stress disorder, eating disorder, or major depressive disorder that requires a different treatment based in the opinion of the PI.

Acutely unstable medical/psychiatric condition (e.g. self-injury, suicidality) that would preclude study participation in the opinion of the PI

Trial design

Design model

Single group

Treatments tested in this trial

Lief Smart Patch
Device
The Lief Smart Patch is a commercially available, noninvasive wearable heart rate variability biofeedback (HRVB) device. The patch includes an embedded electrocardiogram (ECG) sensor and accelerometer that interfaces with a companion smartphone application to deliver paced breathing exercises and just-in-time adaptive intervention (JITAI) prompts. It is an externally worn patch that temporarily adheres to the skin surface and can be removed by the participant.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Heart rate variability biofeedbackExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Mean 8-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score

The PARS, a clinician-administered measure of child anxiety symptom severity based on both patient and parent-report will be the primary outcome measure. It has demonstrated inter-rater and test-retest reliability, and has previously been used by our group as the primary outcome measure in a RCT of mirtazapine for anxiety in youth with ASD, demonstrating sensitivity to change. The 5-item PARS score will be the primary outcome measure for this trial. Scaled score ranges from 0-25 with higher scores indicating more severe anxiety symptoms.

Time frame

Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported

Secondary outcomes

Proportion of Participants who Responded to Treatment at 8 Weeks According to the Improvement Item of the Clinical Global Impression-Improvement (CGI-I) (Response Defined as CGI-I = 1 or 2)

The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scales indicating improvement (1=very much improved; 2=much improved). In this study, the CGI-I will be focused on the target symptom of anxiety.

Time frame

Week 4, Week 8. Week 8 score reported.

Mean 8-Week Change in Clinical Global Impression Severity Subscale (CGI-S)

The CGI-S is rated on a scale from 1 to 7, where 1 = normal, not at all ill; 3 = mildly ill; 5 = markedly ill; 7 = among the most extremely ill patients. The CGI-S will be rated based on the severity of anxiety symptoms.

Time frame

Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported.

Mean 8-Week Change in Parent-Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD) Score

The PRAS-ASD is a novel parent-rated 25-item scale with demonstrated reliability and validity. Scores range from 0-75, with higher scores indicating more severe parent-rated anxiety.

Time frame

Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported.

mHealth App Usability Questionnaire (MAUQ) Standalone Apps for Patients

Mean Likert rating on the mHealth App Usability Questionnaire (MAUQ) Standalone Apps for Patients. The MAUQ includes 18 questions, each rated on a Likert scale of 1-7. Total scores range from 18-126, with higher scores indicating increased usability.

Time frame

Week 8

Other outcomes

Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Irritability Subscale Score

The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis. It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment. The Irritability Subscale is derived from 15 items, with a score range from 0-45, where higher scores indicate more severe irritability.

Time frame

Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported

Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Lethargy/Social Withdrawal Subscale Score

The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis. It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment. The Lethargy/Withdrawal Subscale is derived from 16 items, with a score range from 0-48 where higher scores indicate more severe Lethargy/Withdrawal symptoms.

Time frame

Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported

Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Stereotypic Behavior Subscale Score

The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis. It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment. The Stereotypic Behavior Subscale is derived from 7 items, with a score range of 0-21 where higher scores indicate more severe stereotypic behaviors.

Time frame

Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported

Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Hyperactivity Subscale Score

The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis. It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment. The Hyperactivity Subscale is derived from 16 items with a score range of 0-48, where severe scores indicate more severe hyperactivity symptoms.

Time frame

Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Eagles Autism Foundation

Collaborator

Source ClinicalTrials.gov

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