Meccanismi fisiologici degli effetti dell'intervento terapeutico sull'equitazione in una popolazione psichiatrica di giovani ASD
24 luglio 2026 aggiornato da: University of Colorado, Denver
Meccanismi fisiologici di azione relativi agli effetti dell'intervento terapeutico a cavallo immediato e a lungo termine in una popolazione psichiatrica di giovani con disturbo dello spettro autistico
Questo studio di controllo randomizzato (RCT) cerca di valutare i meccanismi alla base degli effetti positivi significativi dell'equitazione terapeutica (THR) precedentemente osservati sui giovani con ASD, in particolare quelli con disturbi psichiatrici concomitanti, e di perfezionare le informazioni sulla durata, la dose e la sottopopolazione effetti dell'intervento.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
Questo studio di controllo randomizzato (RCT) metterà alla prova l'ipotesi che i modelli di risposta fisiologica del cortisolo salivare, dell'attività cardiovascolare ed elettrodermica spiegano i nostri esiti significativi precedentemente osservati (cioè, ridotta irritabilità e iperattività e miglioramento sociale e della comunicazione) e ulteriori esiti ( regolazione delle emozioni qualità della vita del caregiver e utilizzo dell'assistenza sanitaria in crisi), nei giovani di età compresa tra 6 e 16 anni.
con ASD e diagnosi psichiatriche concomitanti randomizzate a un intervento di THR manualizzato di 10 settimane rispetto a un controllo di Barn Activity (BA) senza cavalli (Obiettivo 1).
Valuteremo la durabilità dei risultati dell'Aim 1 nel gruppo THR rispetto al gruppo di controllo BA sei mesi dopo il periodo di intervento (Obiettivo 2).
Infine, esploreremo gli effetti della dose e della sottopopolazione degli interventi THR e BA confrontando le differenze di dimensione dell'effetto nei gruppi THR e BA con (a) un gruppo di controllo in lista di attesa di 10 settimane; (b) un gruppo di intervento ibrido (cinque settimane BA seguite da cinque settimane THR); e (c) un sottocampione della popolazione dello studio THR randomizzata dopo il ricovero psichiatrico (Obiettivo 3).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
236
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Colorado
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Aurora, Colorado, Stati Uniti, 80218
- University of Colorado Anschutz Medical Campus
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Maine
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Portland, Maine, Stati Uniti, 04102
- Maine Health
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 6 anni a 17 anni (Bambino)
Accetta volontari sani
Sì
Descrizione
Criterio di inclusione:
- diagnosi documentata di ASD e un disturbo psichiatrico concomitante
- Punteggio della sottoscala di irritabilità ABC ≥8
- QI non verbale Leiter-III ≥ 40
- soddisfare il punteggio del criterio dei sintomi (numero minimo di sintomi necessari per un DSM-V (diagnosi di umore, ansia o ADHD) su CASI-5)
- soddisfare i cut-off ASD su SCQ (≥ 11) e su ADOS-2
- Solo un bambino con ASD per famiglia per mantenere osservazioni indipendenti
- un caregiver coerente (ad esempio, genitore o tutore legale) per completare le misure dei risultati dello studio
Criteri di esclusione:
- problemi medici o comportamentali che impediscono la partecipazione
- rione dello stato
- giudicato durante la schermata del centro di guida per avere un'esperienza di guida significativa
- fumo o uso regolare di steroidi orali, inalatori o topici su base regolare, fattori noti per influenzare i livelli di cortisolo
- I partecipanti di peso pari o superiore a 200 libbre saranno esclusi a causa delle politiche di sicurezza del centro ippico
- I partecipanti non saranno autorizzati a iniziare le valutazioni di base fino a quando non saranno trascorsi almeno sei mesi dall'ultima volta in cui si sono impegnati nell'EAAT montato, data l'evidenza pilota per il mantenimento di sei mesi degli effetti della THR.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Lista d'attesa
Quelli assegnati al gruppo della lista d'attesa non avranno alcun intervento relativo al cavallo durante un periodo di attesa di 10 settimane.
Dopo questo periodo di attesa e il completamento delle valutazioni post, i partecipanti in questa condizione inizieranno un gruppo ibrido (vedi Hybrid Arm)
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Sperimentale: Equitazione terapeutica
Questo braccio è un piccolo gruppo di 10 settimane di un'ora (2-4 partecipanti) guidato da un istruttore THR.
Il gruppo includerà un'attività a cavallo di 45 minuti per apprendere le abilità di equitazione come delineato nel manuale THR dello studio.
Gli orari del gruppo saranno tra le 13:00 e le 17:00 per raccogliere il cortisolo salivare.
Settimanalmente, i partecipanti seguiranno una routine coerente indossando sia i dispositivi per il monitoraggio dell'attività elettrodermica che della frequenza cardiaca, si siederanno a un tavolo artistico di gruppo prima della lezione, dopodiché il personale dello studio istruirà i partecipanti a posizionare l'asta del tampone di schiuma lunga 10 cm sotto la lingua per un minuto mentre si guarda un timer da 1 minuto.
I partecipanti indosseranno quindi i loro caschi da equitazione ed entreranno nell'arena di equitazione.
Ogni settimana, dopo la conclusione dell'intervento THR, i partecipanti si siederanno nuovamente con il loro gruppo a un tavolo artistico per 5 minuti, seguiti da un altro campione di saliva.
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Ippoterapia
Altri nomi:
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Comparatore attivo: Attività del fienile
Questo braccio è un piccolo gruppo di 10 settimane di un'ora (2-4 partecipanti) guidato da un istruttore THR e co-guidato da un operatore di salute mentale o di terapia occupazionale.
Ai partecipanti verrà assegnato un volontario e non avranno alcun contatto fisico con i cavalli nel centro ippico, ma potranno solo vedere i cavalli a distanza.
Ci sarà un cavallo di peluche a grandezza naturale per l'apprendimento pratico relativo all'argomento settimanale secondo il manuale di studio BA.
Gli orari del gruppo saranno tra le 13:00 e le 17:00 per raccogliere il cortisolo salivare.
Settimanalmente, i partecipanti seguiranno una routine coerente indossando sia i dispositivi per il monitoraggio dell'attività elettrodermica che della frequenza cardiaca, si siederanno a un tavolo artistico di gruppo prima della lezione, dopodiché il personale dello studio istruirà i partecipanti a posizionare l'asta del tampone di schiuma lunga 10 cm sotto la lingua per un minuto mentre si guarda un timer da 1 minuto.
Ogni settimana, dopo la conclusione dell'intervento BA, i partecipanti si siederanno nuovamente con il loro gruppo a un tavolo artistico per 5 minuti, seguiti da un altro campione di saliva.
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Gruppo di equitazione
Altri nomi:
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Sperimentale: Ibrido
I partecipanti che completano la lista d'attesa Arm e postano le valutazioni, inizieranno un gruppo ibrido tra le 13:00 e le 17:00.
Il gruppo è composto da un piccolo gruppo BA di 5 settimane e 1 ora (2-4 partecipanti) guidato da un istruttore THR e co-guidato da un consulente per la salute mentale o OT.
Ai partecipanti verrà assegnato un volontario e non avranno alcun contatto fisico con i cavalli nel centro ippico, ma potranno solo vedere i cavalli a distanza.
Ci sarà un cavallo di peluche a grandezza naturale per l'apprendimento pratico degli argomenti settimanali secondo il manuale di studio BA.
Gruppo.
Quindi, i partecipanti completeranno 5 settimane di equitazione terapeutica in piccoli gruppi (2-4 partecipanti) guidati da un istruttore THR.
Il gruppo includerà un'attività a cavallo di 45 minuti per apprendere le abilità di equitazione seguita da un'attività di strigliatura e virata del cavallo non a cavallo di 15 minuti secondo il manuale THR.
Ai partecipanti verrà assegnato un cavallo e dei volontari.
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Attività a terra ea cavallo
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Aberrant Behavior Checklist-Community (ABC-C) - Baseline
Lasso di tempo: Baseline
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The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e.
Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale.
THIS MEASURE DOES NOT GENERATE A TOTAL SCORE.
Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems.
The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
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Baseline
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Aberrant Behavior Checklist-Community (ABC-C) - End of Treatment
Lasso di tempo: End of Treatment
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The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e.
Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale.
THIS MEASURE DOES NOT GENERATE A TOTAL SCORE.
Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems.
The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
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End of Treatment
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Aberrant Behavior Checklist-Community (ABC-C) - 6 Months Post Treatrment
Lasso di tempo: 6 months post intervention
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The ABC is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e.
Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale.
THIS MEASURE DOES NOT GENERATE A TOTAL SCORE.
Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems.
The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
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6 months post intervention
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Social Responsiveness Scale™, Second Edition - End of Treatment
Lasso di tempo: End of Treatment
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The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD.
THIS STUDY USED RAW SCORES FOR ANALYSES.
FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME.
Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134.
Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19.
Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of g 28.
Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26.
Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
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End of Treatment
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Social Responsiveness Scale™, Second Edition - 6 Months Post Treatment
Lasso di tempo: 6 months post intervention
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The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD.
THIS STUDY USED RAW SCORES FOR ANALYSES.
FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME.
Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134.
Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19.
Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28.
Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26.
Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
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6 months post intervention
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Emotion Dysregulation Inventory (EDI) - Baseline
Lasso di tempo: Baseline
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The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately.
The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions.
The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness.
Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here).
The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
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Baseline
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Emotion Dysregulation Inventory (EDI) - End of Treatment
Lasso di tempo: End of Treatment
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The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately.
The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions.
The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness.
Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here).
The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
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End of Treatment
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Emotion Dysregulation Inventory (EDI) - 6 Months Post Treatment
Lasso di tempo: 6 months post intervention
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The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately.
The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions.
The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness.
For each scale (Reactivity and Dysphoria), raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here).
The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
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6 months post intervention
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Systematic Analysis of Language Transcripts (SALT) - Baseline
Lasso di tempo: Baseline
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Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD.
The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database.
A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment.
Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
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Baseline
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Systematic Analysis of Language Transcripts (SALT) - End of Treatment
Lasso di tempo: End of Treatment
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Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD.
The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database.
A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment.
Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
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End of Treatment
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Systematic Analysis of Language Transcripts (SALT) - 6 Months Post Treatment
Lasso di tempo: 6 months post treatment
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Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD.
The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database.
A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment.
Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
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6 months post treatment
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World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - Baseline
Lasso di tempo: Baseline
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The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale.
Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items).
Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.
Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
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Baseline
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World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - End of Treatment
Lasso di tempo: End of Treatment
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The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale.
Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items).
Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.
Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
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End of Treatment
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World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - 6 Months Post Treatment
Lasso di tempo: 6 months post intervention
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The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale.
Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items).
Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
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6 months post intervention
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Social Responsiveness Scale™, Second Edition - Baseline
Lasso di tempo: Baseline
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The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD.
The Social Responsiveness Scale™-Second Edition generates raw scores and t-scores for both the combined total score as well as for each of the 5 subscales (social awareness, social cognition, social communication, social motivation, and restricted/repetitive behaviors).
NOTE: THIS STUDY USED THE RAW SCORES FOR ANALYSES.
The combined Social Responsiveness Scale™-Second Edition total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134.
HIGHER SCORES ON THIS SCALE INDICATE WORSE OUTCOMES.
The Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19.
HIGHER SCORES ON THIS SUBSCALE INDICATE WORSE OUTCOMES.
The Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28.
HIGHER SCORES ON THIS SUBSCALE.
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Baseline
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Salivary Cortisol - Baseline Baseline
Lasso di tempo: Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
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Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before (i.e., "Pre-session") and 20 minutes after (i.e., "Post-Session) each THR or BA group session weeks 1-10.
Salivary cortisol collected pre- and -post intervention activities were analyzed separately.
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Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
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Salivary Cortisol - Mid-Point
Lasso di tempo: Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
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Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10.
Salivary cortisol collected pre- and -post intervention activities were analyzed.
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Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
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Salivary Cortisol - End of Treatment
Lasso di tempo: Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
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Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10.
Salivary cortisol collected pre- and -post intervention activities were analyzed.
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Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
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Heart Rate Variability - Baseline
Lasso di tempo: Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
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The Shimmer3 cardiac (ECG) monitor was used in this study.
This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion.
The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively.
It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125
It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing.
Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson.
Unit of measure is ms log-10 transformed.
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Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
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Heart Rate Variability - Mid-point
Lasso di tempo: Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
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The Shimmer3 cardiac (ECG) monitor was used in this study.
This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion.
The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively.
It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125
It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing.
Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson.
Unit of measure is ms log-10 transformed.
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Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
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Heart Rate Variability - End of Treatment
Lasso di tempo: Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
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The Shimmer3 cardiac (ECG) monitor was used in this study.
This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion.
The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively.
It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125
It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing.
Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson.
Unit of measure is ms log-10 transformed.
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Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
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Electrodermal Activity -- Baseline
Lasso di tempo: Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
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The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes.
As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used.
EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range.
Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile.
The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry.
Participants' Shimmer3 EDA assessments were measured during the intervention lesson.
Unit of measure is microsiemens.
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Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
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Electrodermal Activity - Mid-point
Lasso di tempo: Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
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The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes.
As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used.
EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range.
Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile.
The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry.
Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson.
Unit of measure is microsiemens.
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Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
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Electrodermal Activity - End of Treatment
Lasso di tempo: Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).
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The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes.
As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used.
EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range.
Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile.
The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry.
Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson.
Unit of measure is microsiemens.
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Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Robin L Gabriels, Psy.D., University of Colorado Anzchutz Medical Campus
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
22 dicembre 2020
Completamento primario (Effettivo)
22 febbraio 2025
Completamento dello studio (Effettivo)
22 febbraio 2025
Date di iscrizione allo studio
Primo inviato
15 ottobre 2020
Primo inviato che soddisfa i criteri di controllo qualità
22 ottobre 2020
Primo Inserito (Effettivo)
28 ottobre 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 19-1962
- 1R01HD097693-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .