Heart Rate Variability Biofeedback for Anxiety in Autistic Youth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-arm, 8-week trial, 50 youths with autism and clinically significant anxiety will use the Lief Smart Patch to practice heart rate variability biofeedback remotely. The device provides ECG data, motion sensing, and a smartphone app to guide in-the-moment and scheduled breathing-based anxiety relief. The study aims to assess how acceptable and feasible this approach is in autistic youth and to explore preliminary signals of efficacy on anxiety symptoms. Eligible participants are 12–17 years old with ASD, adequate IQ, and stable medications, able to wear the patch for the full duration. The trial is led by Massachusetts General Hospital with Eagles Autism Foundation as a collaborator and will be conducted at the Lurie Center in Lexington, MA.

Why it matters

Who can join: the full rules

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

Where it's running

• Lurie Center
  Lexington, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Robyn P. Thom, MD
• Email: luriecenterresearch@mgb.org
• Phone: 781-860-1711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.