Předběžná účinnost ergoterapie integrující koně na seberegulaci u mládeže s autismem
Předběžná účinnost ergoterapie integrující koně na seberegulaci u mládeže s poruchou autistického spektra
The goal of this clinical trial is to learn about occupational therapy integrating horses for autistic youth. The main questions it aims to answer are:
- Does occupational therapy integrating horses improve self-regulation in autistic youth
- Does occupational therapy integrating horses affect salivary cortisol and alpha-amylase
Participants will receive 10 weeks of occupational therapy, and will be asked to provide saliva samples each week.
Researchers will compare occupational therapy integrating horses to occupational therapy in a clinic to see if integrating horses affects self-regulation.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The goal of this project is to quantify the unique benefits of integrating horses in occupational therapy compared to occupational therapy in a clinic (i.e., OTEE HORS vs. OT Clinic) for improving self-regulation in youth with ASD.
To address both aims we will randomize 64 youth with ASD ages 6-11 years old to OTEE HORS or OT clinic.
Specific Aim 1: Examine the preliminary efficacy of OTEE HORS compared to OT Clinic on self-regulation. Hypotheses: The OTEE HORS group will demonstrate significantly larger improvements than the OT Clinic group in five domains of self-regulation (hyperactivity [primary], irritability, emotional reactivity, dysphoria, and individual goal attainment).
Specific Aim 2: Identify potential physiological mechanisms that explain how integration of horses in occupational therapy impacts self-regulation in youth with ASD. Hypotheses 2A & B: The OTEE HORS group will demonstrate significantly larger decreases in salivary cortisol after each 60-minute therapy session and after the 10-week treatment course in comparison to the OT Clinic group. Hypotheses 2C & 2D: The OTEE HORS group will demonstrate significantly greater increases in salivary alpha-amylase after each 60-minute therapy session, and significantly greater decreases in salivary alpha-amylase over time as measured after the 10-week treatment course in comparison to the OT Clinic group. Exploratory Hypothesis 2E: Changes in physiological measures will significantly correlate with changes in Aim 1 behavioral measures.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Colorado
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Denver, Colorado, Spojené státy, 80216
- Temple Grandin Equine Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- meet clinical cut-offs for ASD on the Autism Diagnostic Observation Schedule, Second Edition(ADOS-2) and Social Communication Questionnaire (≥ 11)
- nonverbal IQ≥65 on Leiter International Performance Scale Third Edition (Leiter-3)
- verbally fluent defined by meeting standard administration criteria for ADOS-2 module 3
- score >10 on the irritability subscale of the aberrant behavior checklist
- able to tolerate a helmet and ride a horse for 10 minutes while following safety rules
- and able to provide a saliva sample
Exclusion Criteria:
- weigh more than 200 pounds
- smoke or regularly use steroids
- receive outpatient occupational therapy
- have 10+ hours horseback riding experience in the previous 6 months
- history of animal abuse or phobia of horses
- have a sibling previously enrolled in the study
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Occupational Therapy Integrating Horses
10 weeks of occupational therapy focused on self-regulation skills, provided while participants are riding horses |
10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses |
|
Aktivní komparátor: Occupational Therapy in a Clinic
10 weeks of occupational therapy focused on self-regulation skills, provided in a traditional clinic environment |
10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Hyperactivity
Časové okno: Week 1 & Week 10
|
The Hyperactivity subscale of the Aberrant Behavior Checklist, Second Edition (ABC-2) measures parent/caregiver-reported hyperactive and impulsive behaviors, including excessive activity, impulsivity, and difficulty remaining still or attending. The subscale consists of 16 items, with total scores ranging from 0-48. Higher scores indicate greater hyperactivity and more severe behavioral difficulties, while lower scores indicate less hyperactivity and better behavioral functioning. Item scores are summed to produce the subscale score. |
Week 1 & Week 10
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Irritability
Časové okno: Week 1 & Week 10
|
The Irritability subscale of the Aberrant Behavior Checklist, Second Edition (ABC-2) measures behaviors associated with irritability, including aggression, self-injury, tantrums, and mood instability. The subscale consists of 15 items, with total scores ranging from 0-45. Higher scores indicate greater irritability and more severe behavioral difficulties, while lower scores indicate less irritability and better behavioral functioning. Items are rated based on the presence and severity of behaviors, and item scores are summed to produce the subscale score. |
Week 1 & Week 10
|
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Change in Emotional Reactivity
Časové okno: Week 1 & Week 10
|
The Emotional Reactivity subscale of the Emotion Dysregulation Inventory (EDI) measures the tendency to experience intense, rapidly escalating, and prolonged negative emotional responses. T-scores are standardized scores derived from the raw Emotional Reactivity score and have a mean of 50 and standard deviation of 10 in the normative sample. Higher T-scores indicate greater emotional reactivity and more severe emotion dysregulation, while lower T-scores indicate less emotional reactivity and better emotional regulation. |
Week 1 & Week 10
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Change in Dysphoria
Časové okno: Week 1 & Week 10
|
The Dysphoria subscale of the Emotion Dysregulation Inventory (EDI) measures symptoms of negative mood, including sadness, hopelessness, and emotional distress. T-scores are standardized scores derived from the raw Dysphoria score and have a mean of 50 and standard deviation of 10 in the normative sample. Higher T-scores indicate greater dysphoria and more severe negative mood symptoms, while lower T-scores indicate less dysphoria and better emotional well-being. |
Week 1 & Week 10
|
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Change in Concentration of Salivary Cortisol
Časové okno: Pre-session, Post-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
|
Change in Concentration of Salivary Cortisol from before-session, after-session, and 20 mins after-session. Saliva samples from Weeks 2, 6, and 10 at pre-session, post-session, and post-session +20, were assayed for cortisol content and included in the linear mixed model analyses. |
Pre-session, Post-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
|
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Change in Concentration of Salivary Alpha-amylase
Časové okno: Pre-session, Within-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
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Change in concentration of salivary alpha-amylase from before-session, during-session, and 20 mins after-session. Saliva samples from Weeks 2, 6, and 10 at pre-session, within-session, and post-session +20, were assayed for alpha-amylase content and included in the linear mixed model analyses. |
Pre-session, Within-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
|
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Emotional Awareness Goal Attainment
Časové okno: Week 10
|
Attainment of individualized emotional awareness goal. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal, level 0 indicates goal was met. |
Week 10
|
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Self-regulation Tool Identification Goal Attainment
Časové okno: Week 10
|
Attainment of individualized goal related to identifying self-regulation tools. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal, level 0 indicates goal was met. |
Week 10
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Self-regulation Tool Use Goal Attainment
Časové okno: Week 10
|
Attainment of individualized goal related to using self-regulation tools. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal, level 0 indicates goal was met. |
Week 10
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Brittany C Peters, PhD, Colorado State University
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 4049
- 1R21HD109957-01 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
De-identified data will be shared in an appropriate data repository, such as the "Data and Specimen Hub" (DASH) or the "National Database for Autism Research" (NDAR). Data will be shared no later than the acceptance for publication of the main findings from the final dataset. Salimetrics will discard saliva samples after testing, and therefore saliva samples will not be available for sharing.
Časový rámec sdílení IPD
We will share in an appropriate data repository indefinitely, no later than the acceptance for publication of the main findings from the final dataset
Typ podpůrných informací pro sdílení IPD
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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