Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism
NCT ID: NCT05846932
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2023-03-21
2025-11-01
Brief Summary
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* 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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Occupational Therapy Integrating Horses
10 weeks of occupational therapy focused on self-regulation skills, provided while participants are riding horses
OTEE HORS
10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses
Occupational Therapy in a Clinic
10 weeks of occupational therapy focused on self-regulation skills, provided in a traditional clinic environment
OT Clinic
10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic
Interventions
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OTEE HORS
10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses
OT Clinic
10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
11 Years
ALL
Yes
Sponsors
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University of Colorado, Denver
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Colorado State University
OTHER
Responsible Party
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Principal Investigators
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Brittany C Peters, PhD
Role: PRINCIPAL_INVESTIGATOR
Colorado State University
Locations
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Temple Grandin Equine Center
Denver, Colorado, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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Temple Grandin Equine Center Denver
Other Identifiers
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4049
Identifier Type: -
Identifier Source: org_study_id