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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: OTEE HORS; Behavioral: OT Clinic

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80216
      • Temple Grandin Equine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: University of Colorado, Denver; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Brittany C Peters, PhD, Colorado State University

Publications and helpful links

Helpful Links

• Temple Grandin Equine Center Denver

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Actual): April 23, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: self-regulation; occupational therapy; hippotherapy; equine-assisted services
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Behavior; Social Behavior; Autism Spectrum Disorder; Self-Control
• Other Study ID Numbers: 4049; 1R21HD109957-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared in an appropriate data repository, such as the "Data and Specimen Hub" (DASH) or the "National Database for Autism Research" (NDAR). Data will be shared no later than the acceptance for publication of the main findings from the final dataset. Salimetrics will discard saliva samples after testing, and therefore saliva samples will not be available for sharing.
• IPD Sharing Time Frame: We will share in an appropriate data repository indefinitely, no later than the acceptance for publication of the main findings from the final dataset
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No