Mécanismes physiologiques des effets de l'intervention d'équitation thérapeutique dans une population psychiatrique de jeunes TSA
24 juillet 2026 mis à jour par: University of Colorado, Denver
Mécanismes d'action physiologiques liés aux effets immédiats et à long terme de l'intervention thérapeutique à cheval dans une population psychiatrique de jeunes atteints de troubles du spectre autistique
Cet essai contrôlé randomisé (ECR) vise à évaluer les mécanismes sous-jacents à l'équitation thérapeutique (THR) précédemment observé des effets positifs significatifs sur les jeunes TSA, en particulier ceux souffrant de troubles psychiatriques concomitants, et à affiner les informations sur la durabilité, la dose et la sous-population effets de l'intervention.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Cet essai contrôlé randomisé (ECR) testera l'hypothèse selon laquelle les schémas de réponse physiologique du cortisol salivaire, de l'activité cardiovasculaire et électrodermique expliquent nos résultats significatifs observés précédemment (c. régulation des émotions, qualité de vie des soignants et utilisation des soins de santé mentale en situation de crise), chez les jeunes de 6 à 16 ans.
avec TSA et diagnostics psychiatriques concomitants randomisés pour une intervention THR manuelle de 10 semaines par rapport à un contrôle sans activité de grange (BA) (Objectif 1).
Nous évaluerons la durabilité des résultats de l'objectif 1 dans le groupe THR par rapport au groupe témoin BA six mois après la période d'intervention (objectif 2).
Enfin, nous explorerons les effets de dose et de sous-population des interventions PTH et BA en comparant les différences de taille d'effet dans les groupes PTH et BA à (a) un groupe témoin sur liste d'attente de 10 semaines ; (b) un groupe d'intervention hybride (cinq semaines BA suivies de cinq semaines THR); et (c) un sous-échantillon de la population de l'étude PTH randomisée suite à une hospitalisation psychiatrique (Objectif 3).
Type d'étude
Interventionnel
Inscription (Réel)
236
Phase
- N'est pas applicable
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.
Lieux d'étude
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Colorado
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Aurora, Colorado, États-Unis, 80218
- University of Colorado Anschutz Medical Campus
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Maine
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Portland, Maine, États-Unis, 04102
- Maine Health
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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
6 ans à 17 ans (Enfant)
Accepte les volontaires sains
Oui
La description
Critère d'intégration:
- diagnostic documenté de TSA et trouble psychiatrique concomitant
- Score de la sous-échelle d'irritabilité ABC ≥ 8
- Leiter-III QI non verbal ≥ 40
- atteindre le score Symptom Criterion (nombre minimum de symptômes nécessaires pour un DSM-V (diagnostic d'humeur, d'anxiété ou de TDAH) sur CASI-5)
- respecter les seuils de TSA au SCQ (≥ 11) et à l'ADOS-2
- Un seul enfant avec TSA par famille pour maintenir des observations indépendantes
- un soignant constant (c'est-à-dire un parent ou un tuteur légal) pour compléter les mesures des résultats de l'étude
Critère d'exclusion:
- problèmes médicaux ou comportementaux qui empêchent la participation
- pupille de l'état
- jugé lors de l'écran du centre de conduite pour avoir une expérience de conduite significative
- tabagisme ou utilisation régulière de stéroïdes oraux, inhalés ou topiques sur une base régulière, facteurs connus pour affecter les niveaux de cortisol
- Les participants pesant 200 livres ou plus seront exclus en raison des politiques de sécurité du centre équestre
- Les participants ne seront pas autorisés à commencer les évaluations de base avant qu'au moins six mois ne se soient écoulés depuis la dernière fois qu'ils se sont engagés dans l'EAAT monté, compte tenu des preuves pilotes du maintien des effets THR pendant six mois.
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: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Liste d'attente
Les personnes affectées au groupe de la liste d'attente n'auront aucune intervention liée au cheval pendant une période d'attente de 10 semaines.
Après cette période d'attente et l'achèvement des évaluations postérieures, les participants dans cette condition commenceront un groupe hybride (voir bras hybride)
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Expérimental: Équitation thérapeutique
Ce bras est un petit groupe d'une heure de 10 semaines (2 à 4 participants) dirigé par un instructeur THR.
Le groupe comprendra une activité montée de 45 minutes pour acquérir les compétences d'équitation, comme indiqué dans le manuel THR de l'étude.
Les horaires de groupe se situeront entre 13h00 et 17h00 pour collecter le cortisol salivaire.
Chaque semaine, les participants suivront une routine cohérente consistant à porter à la fois leurs appareils électrodermiques d'activité et de surveillance de la fréquence cardiaque, s'asseoir à une table d'art de groupe avant le cours, après cela, le personnel de l'étude demandera aux participants de placer la tige d'écouvillon en mousse de 10 cm de long sous leur langue pendant une minute tout en regardant une minuterie d'une minute.
Les participants enfileront ensuite leur casque d’équitation et entreront dans le manège.
Chaque semaine après la conclusion de l'intervention THR, les participants s'assoiront à nouveau avec leur groupe à une table d'art pendant 5 minutes, suivis d'un autre échantillon de salive.
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Equithérapie
Autres noms:
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Comparateur actif: Activité de la grange
Ce bras est un petit groupe d'une heure de 10 semaines (2 à 4 participants) dirigé par un instructeur THR et codirigé par un prestataire de santé mentale ou d'ergothérapie.
Les participants auront un bénévole désigné et n'auront aucun contact physique avec les chevaux au centre équestre, ils observeront simplement les chevaux à distance.
Il y aura un cheval en peluche grandeur nature pour un apprentissage pratique lié au sujet hebdomadaire décrit dans le manuel d'étude du BA.
Les horaires de groupe se situeront entre 13h00 et 17h00 pour collecter le cortisol salivaire.
Chaque semaine, les participants suivront une routine cohérente consistant à porter à la fois leurs appareils électrodermiques d'activité et de surveillance de la fréquence cardiaque, s'asseoir à une table d'art de groupe avant le cours, après cela, le personnel de l'étude demandera aux participants de placer la tige d'écouvillon en mousse de 10 cm de long sous leur langue pendant une minute tout en regardant une minuterie d'une minute.
Chaque semaine après la conclusion de l'intervention BA, les participants s'assoiront à nouveau avec leur groupe à une table d'art pendant 5 minutes, suivis d'un autre échantillon de salive.
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Groupe d'équitation
Autres noms:
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Expérimental: Hybride
Les participants qui terminent les évaluations de bras et de post-liste d'attente commenceront un groupe hybride entre 13h00 et 17h00.
Le groupe se compose d'un petit groupe BA d'une heure de 5 semaines (2 à 4 participants) dirigé par un instructeur THR et codirigé par un conseiller en santé mentale ou OT.
Les participants auront un bénévole assigné et n'auront aucun contact physique avec les chevaux au centre équestre, ils observeront simplement les chevaux à distance.
Il y aura un cheval en peluche grandeur nature pour un apprentissage pratique de sujets hebdomadaires selon le manuel d'étude du BA.
Groupe.
Ensuite, les participants suivront 5 semaines d'équitation thérapeutique en petit groupe (2 à 4 participants) dirigés par un instructeur THR.
Le groupe comprendra une activité montée de 45 minutes pour apprendre les compétences d'équitation, suivie d'une activité de toilettage et de sellerie de chevaux non montés de 15 minutes conformément au manuel THR.
Les participants auront un cheval assigné et des bénévoles.
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Activités terrestres et équestres
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Aberrant Behavior Checklist-Community (ABC-C) - Baseline
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Salivary Cortisol - Baseline Baseline
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
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Collaborateurs
Les enquêteurs
- Chercheur principal: Robin L Gabriels, Psy.D., University of Colorado Anzchutz Medical Campus
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 (Réel)
22 décembre 2020
Achèvement primaire (Réel)
22 février 2025
Achèvement de l'étude (Réel)
22 février 2025
Dates d'inscription aux études
Première soumission
15 octobre 2020
Première soumission répondant aux critères de contrôle qualité
22 octobre 2020
Première publication (Réel)
28 octobre 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 19-1962
- 1R01HD097693-01A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .