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Heart Rate Variability Biofeedback for Anxiety in Autistic Youth

9 septembre 2026 mis à jour par: Robyn P. Thom, M.D., Massachusetts General Hospital
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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

50

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Heart rate variability biofeedback
Participants will be asked to practice HRVB for 5 minutes twice per day at times of their choosing throughout the 8-week trial. In addition to scheduled practice sessions, participants will be asked to respond to just-in-time adaptive intervention (JITAI) prompts to do brief, ~2-minute bursts of HRVB when the device senses autonomic hyperarousal. Participants will be instructed to complete ≥5 minutes per day of JITAI-delivered HRVB, self-initiated HRVB in response to self-perceived anxiety or stress, or any combination of these two practice modes.
Dispositif: Lief 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean 8-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score
Délai: 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.
Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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)
Délai: 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.
Week 4, Week 8. Week 8 score reported.
Mean 8-Week Change in Clinical Global Impression Severity Subscale (CGI-S)
Délai: 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.
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
Délai: 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.
Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported.
mHealth App Usability Questionnaire (MAUQ) Standalone Apps for Patients
Délai: 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.
Week 8
Feasibility
Délai: 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).
Week 8

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Irritability Subscale Score
Délai: Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
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.
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
Délai: Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
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.
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
Délai: Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
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.
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
Délai: Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
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.
Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Inappropriate Speech Subscale Score
Délai: Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
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 Inappropriate Speech Subscale is derived from 4 items with a score range of 0-12, where higher scores indicate more severe Inappropriate Speech symptoms.
Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
Mean 8-Week Change in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score
Délai: Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
The ADHD-RS is an 18-question, parent-rated assessment reflecting DSM symptoms of ADHD. The score range is 0-54, with higher scores indicating more severe ADHD symptoms.
Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
Mean 8-Week Change in Children's Sleep Habits Questionnaire (CSHQ) Total Score
Délai: Baseline, Week 4, Week 8; Change from Baseline to Week 8 is reported
The CSHQ is a 52-question parent survey used to assess sleep difficulties. 33 items are used to generate the total score, which ranges from 33-99, with a cutoff of >41 suggesting clinically significant sleep problems. Higher scores are indicative of more severe sleep problems.
Baseline, Week 4, Week 8; Change from Baseline to Week 8 is reported

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Massachusetts General Hospital

Collaborateurs

Eagles Autism Foundation

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 mai 2029

Achèvement de l'étude (Estimé)

1 mai 2029

Dates d'inscription aux études

Première soumission

4 septembre 2026

Première soumission répondant aux critères de contrôle qualité

4 septembre 2026

Première publication (Réel)

10 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026P001463

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

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