Anxiety, Autism Spectrum Disorder
Conditions
Keywords
heart rate variability biofeedback, Lief, autism spectrum disorder, anxiety
Brief summary
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.
Detailed description
Fifty youth with autism and clinically significant anxiety will be recruited to participate in a single-arm, 8-week open-label, fully remote trial of HRVB. Participants will utilize the Lief Smart Patch which delivers HRVB training and practice through an embedded ECG monitor, accelerometer, and companion smartphone app. Specific aims of the research include: 1) Determine the acceptability and feasibility of second generation HRVB in autistic youth; and 2) Evaluate the preliminary efficacy of HRVB for the treatment of anxiety in autistic youth.
Interventions
DEVICELief Smart Patch
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.
Sponsors
Massachusetts General Hospital
Eagles Autism Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Age 12-17 years at the time of enrollment. 2. 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. 3. IQ ≥50 based on the Kaufman Brief Intelligence Test (KBIT-2). 4. Clinically significant anxiety, based on the Pediatric Anxiety Rating Scale (PARS) 5-item score of ≥10. 5. Stable medications for ≥30 days. 6. English speaking. 7. Willing to wear the Lief Smart Patch for 8 weeks. 8. English speaking guardian who is willing and able to complete caregiver assessments.
Exclusion criteria
1. Clinically significant cardiac arrhythmia based on parent report. 2. 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. 3. Acutely unstable medical/psychiatric condition (e.g. self-injury, suicidality) that would preclude study participation in the opinion of the PI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean 8-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score | Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Week 4, Week 8. Week 8 score reported. | 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. |
| Mean 8-Week Change in Clinical Global Impression Severity Subscale (CGI-S) | Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported. | 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. |
| Mean 8-Week Change in Parent-Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD) Score | Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported. | 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. |
| mHealth App Usability Questionnaire (MAUQ) Standalone Apps for Patients | Week 8 | 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. |
| Feasibility | Week 8 | Proportion of enrolled youth meeting the scheduled daily practice criterion (≥50% study days with ≥5 minutes combined JITAI-delivered and self-initiated HRVB practice). |
Contacts
CONTACTRobyn P. Thom, MD
Outcome results
None listed