Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism Spectrum Disorder

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: OTEE HORS
* Behavioral: OT Clinic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Youth with be randomized to either receive occupational therapy integrating horses (OTEE HORS) or occupational therapy in a clinic (OT Clinic)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occupational Therapy Integrating Horses<br>10 weeks of occupational therapy focused on self-regulation skills, provided while participants are riding horses | Behavioral: OTEE HORS<br>* 10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses<br>|
| Active Comparator: Occupational Therapy in a Clinic<br>10 weeks of occupational therapy focused on self-regulation skills, provided in a traditional clinic environment | Behavioral: OT Clinic<br>* 10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Aberrant Behavior Checklist, Community | Parent-report checklist of problematic behaviors related to hyperactivity and irritability | Week 1 & Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Emotional Dysregulation Inventory | Parent-report measure of emotional reactivity and dysphoria | Week 1 & Week 10 | 
| Change in Concentration of Salivary Cortisol |  | Week 1, Week 5, Week 10 | 
| Change in Concentration of Salivary Alpha-amylase |  | Week 1, Week 5, Week 10 | 
| Goal Attainment using Goal Attainment Scale | Attainment of individualized self-regulation goals. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal. | Week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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occupational therapy, hippotherapy, equine-assisted services, self-regulation