Autism Spectrum Disorder
Conditions
Keywords
occupational therapy, hippotherapy, equine-assisted services, self-regulation
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.
Interventions
BEHAVIORALOTEE HORS
10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses
BEHAVIORALOT Clinic
10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic
Sponsors
University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Colorado State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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).
Intervention model description
Youth with be randomized to either receive occupational therapy integrating horses (OTEE HORS) or occupational therapy in a clinic (OT Clinic)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Aberrant Behavior Checklist, Community | Week 1 & Week 10 | Parent-report checklist of problematic behaviors related to hyperactivity and irritability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 6, Week 10 | — |
| Change in Concentration of Salivary Alpha-amylase | Week 1, Week 6, 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. |
Countries
United States
Outcome results
None listed