Clinical trial NCT05846932: Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism
Official title: Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: occupational therapy
hippotherapy
equine-assisted services
self-regulation
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-05-06
Enrollment: 73
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Youth with be randomized to either receive occupational therapy integrating horses (OTEE HORS) or occupational therapy in a clinic (OT Clinic)
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Aberrant Behavior Checklist, Community
timeFrame: Week 1 & Week 10
Secondary outcomes:
measure: Change in Emotional Dysregulation Inventory
timeFrame: Week 1 & Week 10
measure: Change in Concentration of Salivary Cortisol
timeFrame: Week 1, Week 6, Week 10
measure: Change in Concentration of Salivary Alpha-amylase
timeFrame: Week 1, Week 6, Week 10
measure: Goal Attainment using Goal Attainment Scale
timeFrame: Week 10
Other outcomes:
Locations:
city: Denver
country: United States
facility: Temple Grandin Equine Center
state: Colorado
Study officials:
affiliation: Colorado State University
name: Brittany C Peters, PhD
role: PRINCIPAL_INVESTIGATOR
References: