Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism Spectrum Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Colorado State University
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Change in Aberrant Behavior Checklist, Community
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in Aberrant Behavior Checklist, Community
Time Frame: Week 1 & Week 10
Parent-report checklist of problematic behaviors related to hyperactivity and irritability
Secondary Outcomes
- Change in Emotional Dysregulation Inventory(Week 1 & Week 10)
- Change in Concentration of Salivary Cortisol(Week 1, Week 6, Week 10)
- Change in Concentration of Salivary Alpha-amylase(Week 1, Week 6, Week 10)
- Goal Attainment using Goal Attainment Scale(Week 10)