Autism Spectrum DisorderNCT05846932
Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism
A study testing OTEE HORS and OT Clinic in people with Autism Spectrum Disorder, run by Colorado State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- OTEE HORS and OT Clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2023to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple Grandin Equine Center
Denver, Colorado, 80216
About this study
Official title: Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism Spectrum Disorder
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- OTEE HORS, OT Clinic
- Keywords
- occupational therapy, hippotherapy, equine-assisted services, self-regulation
- Medical subject headings
- Autism Spectrum Disorder, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTEE HORSBehavioural
10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses
OT ClinicBehavioural
10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy Integrating Horses | Experimental | 10 weeks of occupational therapy focused on self-regulation skills, provided while participants are riding horses Receives: 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 Receives: Behavioral: OT Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1 & Week 10
Secondary outcomes (8)
Change in Irritability
The Irritability subscale of the Aberrant Behavior Checklist, Second Edition (ABC-2) measures behaviors associated with irritability, including aggression, self-injury, tantrums, and mood instability. The subscale consists of 15 items, with total scores ranging from 0-45. Higher scores indicate greater irritability and more severe behavioral difficulties, while lower scores indicate less irritability and better behavioral functioning. Items are rated based on the presence and severity of behaviors, and item scores are summed to produce the subscale score.
Measured: Week 1 & Week 10
Change in Emotional Reactivity
The Emotional Reactivity subscale of the Emotion Dysregulation Inventory (EDI) measures the tendency to experience intense, rapidly escalating, and prolonged negative emotional responses. T-scores are standardized scores derived from the raw Emotional Reactivity score and have a mean of 50 and standard deviation of 10 in the normative sample. Higher T-scores indicate greater emotional reactivity and more severe emotion dysregulation, while lower T-scores indicate less emotional reactivity and better emotional regulation.
Measured: Week 1 & Week 10
Change in Dysphoria
The Dysphoria subscale of the Emotion Dysregulation Inventory (EDI) measures symptoms of negative mood, including sadness, hopelessness, and emotional distress. T-scores are standardized scores derived from the raw Dysphoria score and have a mean of 50 and standard deviation of 10 in the normative sample. Higher T-scores indicate greater dysphoria and more severe negative mood symptoms, while lower T-scores indicate less dysphoria and better emotional well-being.
Measured: Week 1 & Week 10
Change in Concentration of Salivary Cortisol
Change in Concentration of Salivary Cortisol from before-session, after-session, and 20 mins after-session. Saliva samples from Weeks 2, 6, and 10 at pre-session, post-session, and post-session +20, were assayed for cortisol content and included in the linear mixed model analyses.
Measured: Pre-session, Post-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
Change in Concentration of Salivary Alpha-amylase
Change in concentration of salivary alpha-amylase from before-session, during-session, and 20 mins after-session. Saliva samples from Weeks 2, 6, and 10 at pre-session, within-session, and post-session +20, were assayed for alpha-amylase content and included in the linear mixed model analyses.
Measured: Pre-session, Within-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
Emotional Awareness Goal Attainment
Attainment of individualized emotional awareness goal. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal, level 0 indicates goal was met.
Measured: Week 10
Self-regulation Tool Identification Goal Attainment
Attainment of individualized goal related to identifying self-regulation tools. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal, level 0 indicates goal was met.
Measured: Week 10
Self-regulation Tool Use Goal Attainment
Attainment of individualized goal related to using self-regulation tools. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal, level 0 indicates goal was met.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start21 Mar 2023
- Primary completion23 Apr 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Youth with be randomized to either receive occupational therapy integrating horses (OTEE HORS) or occupational therapy in a clinic (OT Clinic)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Brittany C Peters, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846932
- Sponsor's protocol ID
- 4049
- Other IDs
- 1R21HD109957-01
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2023
- Last updated
- 2 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared in an appropriate data repository, such as the "Data and Specimen Hub" (DASH) or the "National Database for Autism Research" (NDAR). Data will be shared no later than the acceptance for publication of the main findings from the final dataset. Salimetrics will discard saliva samples after testing, and therefore saliva samples will not be available for sharing.
Publications
Rankins EM, Aichele S, Granger DA, Hepburn S, Gabriels R, Schmid AA, Peters BC. Effects of Incorporating Horses into Occupational Therapy on Adrenocortical and Sympathetic Nervous System Reactivity and Regulation in Autistic Children: A Randomized Controlled Trial. J Autism Dev Disord. 2026 Oct 10. doi: 10.1007/s10803-026-07540-9. Online ahead of print.
PubMed 42859339
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05846932
- Acronym / sponsor ID
- 4049
- Conditions
- Autism Spectrum Disorder
- Keywords
- occupational therapy, hippotherapy, equine-assisted services, self-regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Posted 2 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Youth with be randomized to either receive occupational therapy integrating horses (OTEE HORS) or occupational therapy in a clinic (OT Clinic)
| Arm | Type | Receives |
|---|---|---|
| Occupational Therapy Integrating Horses | Experimental | Behavioral: OTEE HORS10 weeks of occupational therapy focused on self-regulation skills, provided while participants are riding horses |
| Occupational Therapy in a Clinic | Active comparator | Behavioral: OT Clinic10 weeks of occupational therapy focused on self-regulation skills, provided in a traditional clinic environment |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTEE HORS10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses | Behavioural | Occupational Therapy Integrating Horses |
| OT Clinic10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic | Behavioural | Occupational Therapy in a Clinic |
Primary outcome
Change in Hyperactivity
Time frame: Week 1 & Week 10
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.
8 secondary outcomes
Change in Irritability
Time frame: Week 1 & Week 10
Change in Emotional Reactivity
Time frame: Week 1 & Week 10
Change in Dysphoria
Time frame: Week 1 & Week 10
Change in Concentration of Salivary Cortisol
Time frame: Pre-session, Post-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
Change in Concentration of Salivary Alpha-amylase
Time frame: Pre-session, Within-session, Post-session + 20 min, averaged across Intervention Weeks 2, 6 and 10
Emotional Awareness Goal Attainment
Time frame: Week 10
Self-regulation Tool Identification Goal Attainment
Time frame: Week 10
Self-regulation Tool Use Goal Attainment
Time frame: Week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42859339Rankins EM, Aichele S, Granger DA, Hepburn S, Gabriels R, Schmid AA, Peters BC. Effects of Incorporating Horses into Occupational Therapy on Adrenocortical and Sympathetic Nervous System Reactivity and Regulation in Autistic Children: A Randomized Controlled Trial. J Autism Dev Disord. 2026 Oct 10. doi: 10.1007/s10803-026-07540-9. Online ahead of print.
- Temple Grandin Equine Center DenverLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be shared in an appropriate data repository, such as the "Data and Specimen Hub" (DASH) or the "National Database for Autism Research" (NDAR). Data will be shared no later than the acceptance for publication of the main findings from the final dataset. Salimetrics will discard saliva samples after testing, and therefore saliva samples will not be available for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittany C Peters, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTEE HORS and OT Clinic in people with Autism Spectrum Disorder, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hyperactivity (time frame: Week 1 & Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.