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Completed

NCT Number: NCT05846932

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

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.

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Self-Control Social Behavior

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple Grandin Equine Center

Denver, Colorado, 80216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTEE HORS

Behavioral

10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses

OT Clinic

Behavioral

10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic

Primary outcomes

  1. 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

  1. Change in Emotional Dysregulation Inventory

    Time frame: Week 1 & Week 10

    Parent-report measure of emotional reactivity and dysphoria

  2. Change in Concentration of Salivary Cortisol

    Time frame: Week 1, Week 6, Week 10

  3. Change in Concentration of Salivary Alpha-amylase

    Time frame: Week 1, Week 6, Week 10

  4. Goal Attainment using Goal Attainment Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Colorado, Denver

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 6, 2023
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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