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

NCT05846932 | Completed Results DMC

• 2 other identifiers: 40491R21HD109957-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

occupational therapy; hippotherapy; equine-assisted services; self-regulation

Outcome Measures

Primary Outcomes (1)

• Change in Hyperactivity

  The Hyperactivity subscale of the Aberrant Behavior Checklist, Second Edition (ABC-2) measures parent/caregiver-reported hyperactive and impulsive behaviors, including excessive activity, impulsivity, and difficulty remaining still or attending. The subscale consists of 16 items, with total scores ranging from 0-48. Higher scores indicate greater hyperactivity and more severe behavioral difficulties, while lower scores indicate less hyperactivity and better behavioral functioning. Item scores are summed to produce the subscale score.

  Week 1 & Week 10

Secondary Outcomes (8)

• Change in Irritability

  Week 1 & Week 10

• Change in Emotional Reactivity

  Week 1 & Week 10

• Change in Dysphoria

  Week 1 & Week 10

• Change in Concentration of Salivary Cortisol

  Pre-session, Post-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10

• Change in Concentration of Salivary Alpha-amylase

  Pre-session, Within-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10

Study Arms (2)

Occupational Therapy Integrating Horses

EXPERIMENTAL

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

Behavioral: OTEE HORS

Occupational Therapy in a Clinic

ACTIVE COMPARATOR

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

Behavioral: OT Clinic

Interventions

OTEE HORS BEHAVIORAL

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

Occupational Therapy Integrating Horses

OT Clinic BEHAVIORAL

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

Occupational Therapy in a Clinic

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Temple Grandin Equine Center

Denver, Colorado, 80216, United States

Location

Related Links

• Temple Grandin Equine Center Denver

MeSH Terms

Conditions

Autism Spectrum Disorder; Self-Control

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Limitations and Caveats

This study was underpowered to detect many of the observed between-group effect sizes as the original power analysis estimated medium-large effect sizes. Finally, the study is limited by the high drop-out rate from the OT-ZOR Clinic intervention, and the resulting 2:1 randomization (Clinic: Equine) may have biased the sample with participants well-suited for the Clinic condition.

Results Point of Contact

• Title: B. Caitlin Peters
• Organization: Colorado State University

caiti.peters@colostate.edu

970-491-1469

Study Officials

• Brittany C Peters, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistant that rates goal attainment at the conclusion of therapy will be asked to participants' intervention assignment (OTEE HORS v OT Clinic).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 6, 2023
• Study Start: March 21, 2023
• Primary Completion: April 23, 2025
• Study Completion: November 1, 2025
• Last Updated: October 2, 2026
• Results First Posted: October 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• 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

Locations

US (1)