Heart Rate Variability Biofeedback for Anxiety in Autistic Youth
9 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
50
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Robyn P. Thom, MD
- Número de teléfono: 781-860-1711
- Correo electrónico: luriecenterresearch@mgb.org
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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.
- Stable medications for ≥30 days.
- English speaking.
- Willing to wear the Lief Smart Patch for 8 weeks.
- English speaking guardian who is willing and able to complete caregiver assessments.
Exclusion Criteria:
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean 8-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score
Periodo de tiempo: 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.
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Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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)
Periodo de tiempo: 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.
|
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Mean 8-Week Change in Clinical Global Impression Severity Subscale (CGI-S)
Periodo de tiempo: 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.
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Mean 8-Week Change in Parent-Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD) Score
Periodo de tiempo: 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.
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Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported.
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mHealth App Usability Questionnaire (MAUQ) Standalone Apps for Patients
Periodo de tiempo: 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.
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Week 8
|
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Feasibility
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Irritability Subscale Score
Periodo de tiempo: 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
|
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Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Lethargy/Social Withdrawal Subscale Score
Periodo de tiempo: 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.
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Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
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Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Stereotypic Behavior Subscale Score
Periodo de tiempo: 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
|
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Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Hyperactivity Subscale Score
Periodo de tiempo: 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
|
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Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Inappropriate Speech Subscale Score
Periodo de tiempo: 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.
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Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
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Mean 8-Week Change in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score
Periodo de tiempo: 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.
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Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
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Mean 8-Week Change in Children's Sleep Habits Questionnaire (CSHQ) Total Score
Periodo de tiempo: 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.
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Baseline, Week 4, Week 8; Change from Baseline to Week 8 is reported
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de mayo de 2029
Finalización del estudio (Estimado)
1 de mayo de 2029
Fechas de registro del estudio
Enviado por primera vez
4 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de septiembre de 2026
Publicado por primera vez (Actual)
10 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026P001463
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .