Physiologische Mechanismen der Interventionseffekte des therapeutischen Reitens in einer psychiatrischen Population von ASD-Jugendlichen
24. Juli 2026 aktualisiert von: University of Colorado, Denver
Physiologische Wirkungsmechanismen in Bezug auf unmittelbare und langfristige therapeutische Reitinterventionseffekte in einer psychiatrischen Population von Jugendlichen mit Autismus-Spektrum-Störung
Diese randomisierte Kontrollstudie (RCT) versucht, die Mechanismen zu bewerten, die den zuvor beobachteten signifikanten positiven Effekten des Therapeutischen Reitens (THR) auf ASS-Jugendliche zugrunde liegen, insbesondere solche mit gleichzeitig auftretenden psychiatrischen Störungen, und Informationen über die Dauerhaftigkeit, Dosis und Subpopulation zu verfeinern Auswirkungen des Eingriffs.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Diese randomisierte Kontrollstudie (RCT) wird die Hypothese testen, dass physiologische Reaktionsmuster von Speichel-Cortisol, kardiovaskulärer und elektrodermaler Aktivität für unsere zuvor beobachteten signifikanten Ergebnisse (d. h. verringerte Reizbarkeit und Hyperaktivität und verbesserte soziale und Kommunikation) und zusätzliche Ergebnisse verantwortlich sind ( Emotionsregulation Pflegekraft Lebensqualität und Inanspruchnahme psychischer Gesundheitsversorgung in Krisensituationen), im Jugendalter von 6-16 Jahren.
mit ASD und gleichzeitig auftretenden psychiatrischen Diagnosen randomisiert zu einer 10-wöchigen manuellen THR-Intervention im Vergleich zu einer Kontrolle ohne Pferd (Ziel 1).
Wir werden die Dauerhaftigkeit der Ergebnisse von Ziel 1 in der THR-Gruppe im Vergleich zur BA-Kontrollgruppe sechs Monate nach dem Interventionszeitraum (Ziel 2) bewerten.
Schließlich werden wir die Dosis- und Subpopulationseffekte von THR- und BA-Interventionen untersuchen, indem wir die Unterschiede in der Effektgröße in THR- und BA-Gruppen mit (a) einer 10-wöchigen Wartelisten-Kontrollgruppe vergleichen; (b) eine Hybrid-Interventionsgruppe (fünf Wochen BA, gefolgt von fünf Wochen THR); und (c) eine Teilstichprobe der THR-Studienpopulation, die nach einem psychiatrischen Krankenhausaufenthalt randomisiert wurde (Ziel 3).
Studientyp
Interventionell
Einschreibung (Tatsächlich)
236
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80218
- University of Colorado Anschutz Medical Campus
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Maine
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Portland, Maine, Vereinigte Staaten, 04102
- Maine Health
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
6 Jahre bis 17 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
Einschlusskriterien:
- dokumentierte ASD-Diagnose und eine gleichzeitig auftretende psychiatrische Störung
- Punktzahl der ABC-Reizbarkeits-Subskala ≥8
- Leiter-III Nonverbaler IQ ≥ 40
- Erfüllen des Symptomkriteriums (Mindestanzahl an Symptomen, die für eine DSM-V-Diagnose (Stimmungs-, Angst- oder ADHS-Diagnose) auf CASI-5 erforderlich sind)
- ASD-Grenzwerte beim SCQ (≥ 11) und beim ADOS-2 erfüllen
- Nur ein Kind mit ASD pro Familie, um unabhängige Beobachtungen zu führen
- eine ständige Bezugsperson (d. h. ein Elternteil oder Erziehungsberechtigter), um die Studienergebnismessungen abzuschließen
Ausschlusskriterien:
- medizinische oder Verhaltensprobleme, die eine Teilnahme verhindern
- Bezirk des Staates
- während des Fahrens auf dem zentralen Bildschirm beurteilt, um über erhebliche Fahrerfahrung zu verfügen
- Rauchen oder regelmäßige Einnahme von oralen, inhalativen oder topischen Steroiden auf regelmäßiger Basis, Faktoren, von denen bekannt ist, dass sie den Cortisolspiegel beeinflussen
- Teilnehmer mit einem Gewicht von 200 Pfund oder mehr werden aufgrund der Sicherheitsrichtlinien des Reitzentrums ausgeschlossen
- Den Teilnehmern ist es nicht gestattet, mit den Basisbewertungen zu beginnen, bis mindestens sechs Monate nach dem Zeitpunkt vergangen sind, an dem sie sich das letzte Mal mit montiertem EAAT beschäftigt haben, sofern Pilotnachweise für die sechsmonatige Aufrechterhaltung der THR-Effekte vorliegen.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Kein Eingriff: Warteliste
Diejenigen, die der Wartelistengruppe zugeordnet sind, erhalten während einer 10-wöchigen Wartezeit keine pferdebezogenen Eingriffe.
Nach dieser Wartezeit und dem Abschluss der Post-Assessments beginnen Teilnehmer in diesem Zustand mit einer Hybrid-Gruppe (siehe Hybrid-Arm).
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Experimental: Therapeutisches Reiten
Bei diesem Arm handelt es sich um eine 10-wöchige einstündige Kleingruppe (2-4 Teilnehmer), die von einem THR-Lehrer geleitet wird.
Die Gruppe wird eine 45-minütige Aktivität auf einem Pferd absolvieren, um Reitkünste zu erlernen, wie im THR-Handbuch der Studie beschrieben.
Die Gruppenzeiten liegen zwischen 13:00 und 17:00 Uhr, um Cortisol im Speichel zu sammeln.
Wöchentlich folgen die Teilnehmer einer einheitlichen Routine, bei der sie sowohl ihre elektrodermalen Aktivitäts- als auch ihre Herzfrequenzüberwachungsgeräte tragen und sich vor dem Unterricht an einen Gruppen-Kunsttisch setzen. Danach weist das Studienpersonal die Teilnehmer an, den 10 cm langen Schaumstofftupferstab unter ihre Zunge zu legen eine Minute, während Sie einen 1-Minuten-Timer ansehen.
Anschließend setzen die Teilnehmer ihre Reithelme auf und betreten den Reitplatz.
Jede Woche nach Abschluss der THR-Intervention sitzen die Teilnehmer erneut mit ihrer Gruppe für 5 Minuten an einem Kunsttisch und führen anschließend eine weitere Speichelprobe durch.
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Pferdetherapie
Andere Namen:
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Aktiver Komparator: Scheunenaktivität
Bei diesem Arm handelt es sich um eine 10-wöchige, einstündige Kleingruppe (2–4 Teilnehmer), die von einem THR-Ausbilder geleitet und von einem Anbieter für psychische Gesundheit oder Ergotherapie gemeinsam geleitet wird.
Den Teilnehmern steht ein ehrenamtlicher Helfer zur Seite und sie haben im Reitzentrum keinen physischen Kontakt mit den Pferden, sondern können die Pferde nur aus der Ferne betrachten.
Es wird ein lebensgroßes Stofftierpferd zum praktischen Lernen zum wöchentlichen Thema gemäß dem BA-Studienhandbuch geben.
Die Gruppenzeiten liegen zwischen 13:00 und 17:00 Uhr, um Cortisol im Speichel zu sammeln.
Wöchentlich folgen die Teilnehmer einer einheitlichen Routine, bei der sie sowohl ihre elektrodermalen Aktivitäts- als auch ihre Herzfrequenzüberwachungsgeräte tragen und sich vor dem Unterricht an einen Gruppen-Kunsttisch setzen. Danach weist das Studienpersonal die Teilnehmer an, den 10 cm langen Schaumstofftupferstab unter ihre Zunge zu legen eine Minute, während Sie einen 1-Minuten-Timer ansehen.
Jede Woche nach Abschluss der BA-Intervention sitzen die Teilnehmer erneut mit ihrer Gruppe für 5 Minuten an einem Kunsttisch und führen anschließend eine weitere Speichelprobe durch.
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Reitgruppe
Andere Namen:
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Experimental: Hybrid
Teilnehmer, die die Warteliste absolvieren und Beurteilungen abgeben, beginnen zwischen 13:00 und 17:00 Uhr eine Hybridgruppe.
Die Gruppe besteht aus einer 5-wöchigen 1-stündigen BA-Kleingruppe (2–4 Teilnehmer), die von einem THR-Ausbilder geleitet und von einem Berater für psychische Gesundheit oder einem OT gemeinsam geleitet wird.
Den Teilnehmern wird ein Freiwilliger zugewiesen und sie haben keinen physischen Kontakt mit den Pferden im Reitzentrum, sondern können die Pferde nur aus der Ferne beobachten.
Es wird ein lebensgroßes Stoffpferd zum praktischen Erlernen wöchentlicher Themen gemäß BA-Studienhandbuch geben.
Gruppe.
Anschließend absolvieren die Teilnehmer 5 Wochen lang therapeutisches Reiten in einer kleinen Gruppe (2–4 Teilnehmer) unter der Leitung eines THR-Lehrers.
Die Gruppe umfasst eine 45-minütige Aktivität auf einem Pferd zum Erlernen reiterlicher Fertigkeiten, gefolgt von einer 15-minütigen Aktivität zum Putzen und Anlegen von Pferden ohne Pferd gemäß THR-Handbuch.
Den Teilnehmern werden ein Pferd und Freiwillige zugewiesen.
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Boden- und Reitaktivitäten
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Aberrant Behavior Checklist-Community (ABC-C) - Baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Salivary Cortisol - Baseline Baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).
|
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.
|
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).
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Robin L Gabriels, Psy.D., University of Colorado Anzchutz Medical Campus
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
22. Dezember 2020
Primärer Abschluss (Tatsächlich)
22. Februar 2025
Studienabschluss (Tatsächlich)
22. Februar 2025
Studienanmeldedaten
Zuerst eingereicht
15. Oktober 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. Oktober 2020
Zuerst gepostet (Tatsächlich)
28. Oktober 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 19-1962
- 1R01HD097693-01A1 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .