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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05846932
• Other study ID #: 4049
• Secondary ID: 1R21HD109957-01
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: July 2023
• Source: Colorado State University
• Contact: Brittany C Peters, PhD
• Phone: 720-665-0023
• Email: caiti.peters[@]colostate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Temple Grandin Equine Center	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Colorado State University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Aberrant Behavior Checklist, Community	Parent-report checklist of problematic behaviors related to hyperactivity and irritability	Week 1 & Week 10
Secondary	Change in Emotional Dysregulation Inventory	Parent-report measure of emotional reactivity and dysphoria	Week 1 & Week 10
Secondary	Change in Concentration of Salivary Cortisol		Week 1, Week 5, Week 10
Secondary	Change in Concentration of Salivary Alpha-amylase		Week 1, Week 5, Week 10
Secondary	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

External Links

•   Temple Grandin Equine Center Denver