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

Sponsor

Colorado State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05846932

Collaborator

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

Enrollment

Location

Arms

39.4

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Behavioral: OTEE HORS Behavioral: OT Clinic	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Youth with be randomized to either receive occupational therapy integrating horses (OTEE HORS) or occupational therapy in a clinic (OT Clinic)Youth with be randomized to either receive occupational therapy integrating horses (OTEE HORS) or occupational therapy in a clinic (OT Clinic)

Masking:

Single (Outcomes Assessor)

Masking Description:

The research assistant that rates goal attainment at the conclusion of therapy will be asked to participants' intervention assignment (OTEE HORS v OT Clinic).

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 21, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Aberrant Behavior Checklist, Community [Week 1 & Week 10]
Parent-report checklist of problematic behaviors related to hyperactivity and irritability

Secondary Outcome Measures

Change in Emotional Dysregulation Inventory [Week 1 & Week 10]
Parent-report measure of emotional reactivity and dysphoria
Change in Concentration of Salivary Cortisol [Week 1, Week 5, Week 10]
Change in Concentration of Salivary Alpha-amylase [Week 1, Week 5, Week 10]
Goal Attainment using Goal Attainment Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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