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Fysiologiske mekanismer for terapeutiske rideinterventionseffekter i en psykiatrisk population af ASD-ungdom

24. juli 2026 opdateret af: University of Colorado, Denver

Fysiologiske virkningsmekanismer i forbindelse med øjeblikkelige og langsigtede terapeutiske rideinterventionseffekter i en psykiatrisk population af unge med autismespektrumforstyrrelse

Dette randomiserede kontrolforsøg (RCT) søger at vurdere de mekanismer, der ligger til grund for Terapeutisk Ridning (THR)'s tidligere observerede signifikante positive effekter på ASD-unge, især dem med samtidig forekommende psykiatriske lidelser, og at forfine information om holdbarhed, dosis og subpopulation effekter af interventionen.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

Dette randomiserede kontrolforsøg (RCT) vil teste hypotesen om, at fysiologiske responsmønstre for spytkortisol, kardiovaskulær og elektrodermal aktivitet tegner sig for vores tidligere observerede signifikante resultater (dvs. reduceret irritabilitet og hyperaktivitet og forbedret social og kommunikation) og yderligere resultater ( følelsesregulering pårørendes livskvalitet og krise brug af mental sundhedspleje), hos unge i alderen 6-16 år. med ASD og samtidige psykiatriske diagnoser randomiseret til en 10-ugers manuel THR-intervention sammenlignet med en no-horse Barn Activity (BA) kontrol (Mål 1). Vi vil evaluere holdbarheden af ​​mål 1-resultater i THR-gruppen sammenlignet med BA-kontrolgruppen seks måneder efter interventionsperioden (mål 2). Endelig vil vi undersøge dosis- og subpopulationseffekter af THR- og BA-interventioner ved at sammenligne effektstørrelsesforskelle i THR- og BA-grupper med (a) en 10-ugers ventelistekontrolgruppe; (b) en hybrid interventionsgruppe (fem uger BA efterfulgt af fem ugers THR); og (c) en delprøve af THR-undersøgelsespopulationen randomiseret efter psykiatrisk indlæggelse (mål 3).

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
236

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

  • Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80218
        • University of Colorado Anschutz Medical Campus
    • Maine
      • Portland, Maine, Forenede Stater, 04102
        • Maine Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

6 år til 17 år (Barn)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • dokumenteret ASD-diagnose og en samtidig psykiatrisk lidelse
  • ABC Irritabilitet underskala score ≥8
  • Leiter-III Nonverbal IQ ≥ 40
  • opfylde Symptom Criterion score (minimum antal symptomer, der er nødvendige for en DSM-V (humør, angst eller ADHD-diagnose) på CASI-5)
  • opfylde ASD cut-offs på SCQ (≥ 11) og på ADOS-2
  • Kun ét barn med ASD per familie for at opretholde uafhængige observationer
  • en konsekvent omsorgsperson (dvs. forælder eller værge) til at gennemføre undersøgelsesresultatmål

Ekskluderingskriterier:

  • medicinske eller adfærdsmæssige problemer, der forhindrer deltagelse
  • statens afdeling
  • bedømt under ridecenterskærmen til at have betydelig rideerfaring
  • rygning eller regelmæssig brug af orale, inhalerede eller topiske steroider på regelmæssig basis, faktorer, der vides at påvirke cortisolniveauet
  • Deltagere, der vejer 200 pund eller derover, vil blive udelukket på grund af ridecentrets sikkerhedspolitikker
  • Deltagerne får ikke lov til at påbegynde baseline-vurderinger, før der er gået mindst seks måneder fra det tidspunkt, hvor de sidst var involveret i monteret EAAT, givet pilotbevis for seks måneders opretholdelse af THR-effekter.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Ingen indgriben: Venteliste
De, der er tildelt ventelistegruppen, vil ikke have nogen hesterelateret indgriben i en 10-ugers venteperiode. Efter denne venteperiode og færdiggørelsen af ​​postvurderinger vil deltagere i denne tilstand begynde en hybridgruppe (se Hybridarm)
Eksperimentel: Terapeutisk ridning
Denne arm er en 10 ugers en times lille gruppe (2-4 deltagere) ledet af en THR-instruktør. Gruppen vil inkludere en 45-minutters monteret aktivitet for at lære hestefærdigheder som beskrevet i undersøgelsens THR-manual, . Gruppetider vil være mellem 13:00-17:00 for at indsamle spytkortisol. Ugentligt vil deltagerne følge en konsekvent rutine med at bære både deres elektrodermale aktivitets- og pulsmålingsudstyr, sidde ved et gruppekunstbord før undervisningen, efter dette vil studiepersonalet instruere deltagerne i at placere den 10 cm lange skumpindestav under deres tunge for et minut, mens du ser en 1-minutters timer. Deltagerne vil derefter tage deres ridehjelme på og komme ind på ridebanen. Hver uge efter afslutningen af ​​THR-interventionen vil deltagerne igen sidde med deres gruppe ved et kunstbord i 5 minutter efterfulgt af en ny spytprøve.
Andet: Terapeutisk ridning
Hesteterapi
Andre navne:
  • Hesteassisteret aktivitet
Aktiv komparator: Ladeaktivitet
Denne arm er en 10 ugers en times lille gruppe (2-4 deltagere) ledet af en THR-instruktør og ledet af en udbyder af mental sundhed eller ergoterapi. Deltagerne får en frivillig tildelt og vil ikke have fysisk kontakt med heste på ridecenteret, kun se heste på afstand. Der vil være en udstoppet legetøjshest i naturlig størrelse til praktisk læring relateret til det ugentlige emne i henhold til BA-studiemanualen. Gruppetider vil være mellem 13:00-17:00 for at indsamle spytkortisol. Ugentligt vil deltagerne følge en konsekvent rutine med at bære både deres elektrodermale aktivitets- og pulsmålingsudstyr, sidde ved et gruppekunstbord før undervisningen, efter dette vil studiepersonalet instruere deltagerne i at placere den 10 cm lange skumpindestav under deres tunge for et minut, mens du ser en 1-minutters timer. Hver uge efter afslutningen af ​​BA-interventionen vil deltagerne igen sidde med deres gruppe ved et kunstbord i 5 minutter efterfulgt af en ny spytprøve.
Andet: Ladeaktivitet
Horsemanship gruppe
Andre navne:
  • Ingen hestekontrol
Eksperimentel: Hybrid
Deltagere, der gennemfører Ventelisten Arm- og postvurderinger, vil begynde en hybridgruppe mellem 13:00-17:00. Gruppen består af en 5-ugers 1-times BA-lille gruppe (2-4 deltagere) ledet af en THR-instruktør og ledet af en mental sundhedsrådgiver eller OT. Deltagerne får en frivillig tildelt og har ingen fysisk kontakt med heste på ridecenteret, kun se heste på afstand. Der vil være en udstoppet hest i naturlig størrelse til praktisk indlæring af ugentlige emner pr. BA-studiemanual. Gruppe. Derefter vil deltagerne gennemføre 5 ugers terapeutisk ridning i en lille gruppe (2-4 deltagere) ledet af en THR-instruktør. Gruppen vil inkludere en 45-minutters ridende aktivitet for at lære hestefærdigheder efterfulgt af en 15-minutters umonteret hestepleje- og slagaktivitet i henhold til THR-manualen. Deltagerne får tildelt en hest og frivillig(e).
Andet: Hybrid
Terræn- og rideaktiviteter
Andre navne:
  • Hesteassisteret aktivitet

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Aberrant Behavior Checklist-Community (ABC-C) - Baseline
Tidsramme: Baseline
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.
Baseline
Aberrant Behavior Checklist-Community (ABC-C) - End of Treatment
Tidsramme: End of Treatment
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.
End of Treatment
Aberrant Behavior Checklist-Community (ABC-C) - 6 Months Post Treatrment
Tidsramme: 6 months post intervention
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.
6 months post intervention
Social Responsiveness Scale™, Second Edition - End of Treatment
Tidsramme: End of Treatment
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.
End of Treatment
Social Responsiveness Scale™, Second Edition - 6 Months Post Treatment
Tidsramme: 6 months post intervention
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.
6 months post intervention
Emotion Dysregulation Inventory (EDI) - Baseline
Tidsramme: Baseline
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.
Baseline
Emotion Dysregulation Inventory (EDI) - End of Treatment
Tidsramme: End of Treatment
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.
End of Treatment
Emotion Dysregulation Inventory (EDI) - 6 Months Post Treatment
Tidsramme: 6 months post intervention
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.
6 months post intervention
Systematic Analysis of Language Transcripts (SALT) - Baseline
Tidsramme: Baseline
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.
Baseline
Systematic Analysis of Language Transcripts (SALT) - End of Treatment
Tidsramme: End of Treatment
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.
End of Treatment
Systematic Analysis of Language Transcripts (SALT) - 6 Months Post Treatment
Tidsramme: 6 months post treatment
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.
6 months post treatment
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - Baseline
Tidsramme: Baseline
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.
Baseline
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - End of Treatment
Tidsramme: End of Treatment
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.
End of Treatment
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - 6 Months Post Treatment
Tidsramme: 6 months post intervention
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.
6 months post intervention
Social Responsiveness Scale™, Second Edition - Baseline
Tidsramme: Baseline
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.
Baseline

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Salivary Cortisol - Baseline Baseline
Tidsramme: 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).
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.
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).
Salivary Cortisol - Mid-Point
Tidsramme: 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)
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.
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)
Salivary Cortisol - End of Treatment
Tidsramme: 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).
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.
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).
Heart Rate Variability - Baseline
Tidsramme: 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).
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.
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).
Heart Rate Variability - Mid-point
Tidsramme: 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).
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.
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).
Heart Rate Variability - End of Treatment
Tidsramme: 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).
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.
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).
Electrodermal Activity -- Baseline
Tidsramme: 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).
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.
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).
Electrodermal Activity - Mid-point
Tidsramme: 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).
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.
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).
Electrodermal Activity - End of Treatment
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
University of Colorado, Denver

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Boston Children's Hospital
Baylor University
Colorado State University
Riding To The Top Therapeutic Riding Center
Hearts and Horses Therapeutic Riding Center
Salimetrics, LLC
Maine Health/Spring Harbor Hospital

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Robin L Gabriels, Psy.D., University of Colorado Anzchutz Medical Campus

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
22. december 2020

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
22. februar 2025

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
22. februar 2025

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
15. oktober 2020

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
22. oktober 2020

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
28. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
18. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
24. juli 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 19-1962
  • 1R01HD097693-01A1 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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