NCT05846932

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Colorado State University · Academic / Other
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	OTEE HORS	10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses
BEHAVIORAL	OT Clinic	10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic

Timeline

• Start date: 2023-03-21
• Primary completion: 2025-04-23
• Completion: 2025-11-01
• First posted: 2023-05-06
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States