Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism
- Conditions
- Autism Spectrum Disorder
- Interventions
- Behavioral: OTEE HORSBehavioral: OT Clinic
- Registration Number
- NCT05846932
- Lead Sponsor
- Colorado State University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Occupational Therapy Integrating Horses OTEE HORS 10 weeks of occupational therapy focused on self-regulation skills, provided while participants are riding horses Occupational Therapy in a Clinic OT Clinic 10 weeks of occupational therapy focused on self-regulation skills, provided in a traditional clinic environment
- Primary Outcome Measures
Name Time Method Change in Aberrant Behavior Checklist, Community Week 1 & Week 10 Parent-report checklist of problematic behaviors related to hyperactivity and irritability
- Secondary Outcome Measures
Name Time Method Change in Concentration of Salivary Cortisol Week 1, Week 6, Week 10 Change in Emotional Dysregulation Inventory Week 1 & Week 10 Parent-report measure of emotional reactivity and dysphoria
Change in Concentration of Salivary Alpha-amylase Week 1, Week 6, Week 10 Goal Attainment using Goal Attainment Scale Week 10 Attainment of individualized self-regulation goals. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal.
Trial Locations
- Locations (1)
Temple Grandin Equine Center
🇺🇸Denver, Colorado, United States