Image

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

Recruiting
6 - 11 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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

Study details

Autism Spectrum Disorder

NCT05846932

Colorado State University

26 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.