Autism Spectrum DisorderNCT07897123
Effects of Mounted vs Unmounted Human-Equine Interaction on Autistic Youth
A study testing Mounted Human-equine Interaction and Unmounted Human-equine Interaction 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 how interacting with horses affects autistic children and youth. The main questions it aims to answer are: How does interacting with horses affect cortisol, heart-rate variability, and electrodermal activity in autistic children and youth? How does interacting with horses… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Mounted Human-equine Interaction and Unmounted Human-equine Interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2025to 3 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ages 6-16 years old
- met the clinical cut-offs for autism on the Autism Diagnostic Observation Schedule Second Edition and Social Communication Questionnaire
- had a nonverbal IQ >40 using the Leiter-3 (CITE)
- scored >10 on the Aberrant Behavior Checklist (CITE) Irritability Scale
- could participate in study procedures (ride and groom a horse, provide saliva sample, don monitors).
- In addition, to be included, parents/guardians were required to live with their child at least fifty percent of the time, complete the questionaries in English, and attend all sessions with their child.
Who cannot join
- ridden a horse for ≥10 hours in the past six months
- weighed >200 lbs. per riding center policy
- smoked or were currently using steroids due to their effects on cortisol
- or if a sibling was already 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: The Immediate Effects of Mounted vs Unmounted Human-Equine Interaction on Physiological and Behavioral Indicators of Self-regulation in Autistic Youth
The goal of this clinical trial is to learn how interacting with horses affects autistic children and youth. The main questions it aims to answer are:
- How does interacting with horses affect cortisol, heart-rate variability, and electrodermal activity in autistic children and youth?
- How does interacting with horses affect parent-reported behaviors in autistic children and youth? Researchers will compare riding a horse, brushing a horse, and brushing a pretend stuffed horse to see if there are different effects on autistic children's physiology and behavior.
Read more
Participants will
- Attend three different horsemanship lessons on three consecutive weeks. One horsemanship lesson will be mounted (riding), one unmounted (brushing), and one with a pretend horse (brushing).
- Wear monitors on their chest and wrist
- Provide saliva samples
- Conditions
- Autism Spectrum Disorder
- Being tested
- Mounted Human-equine Interaction, Unmounted Human-equine Interaction, No-Horse Control
- Keywords
- equine-assisted services, emotion regulation, heartrate variability, electrodermal activity, cortisol, human-animal interaction
- Medical subject headings
- Autism Spectrum Disorder, Emotional Regulation, Human-Animal Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mounted Human-equine InteractionBehavioural
Participants ride a horse for 45 minutes
Unmounted Human-equine InteractionBehavioural
Participants groom a horse and learn about equine behavior
No-Horse ControlBehavioural
Participants groom a pretend stuffed horse and learn about equine behavior
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Mounted, Unmounted, No-Horse Control | Other | All participants received all interventions. Participants randomized to Sequence 1 first participated in the mounted condition, followed by the unmounted condition, followed by the no-horse control condition. Receives: Behavioral: Mounted Human-equine Interaction; Behavioral: Unmounted Human-equine Interaction; Behavioral: No-Horse Control |
| Sequence 2: Mounted, No-Horse Control, Unmounted | Other | All participants received all interventions. Participants randomized to Sequence 2 first participated in the mounted condition, followed by the no-horse control condition, followed by the unmounted condition. Receives: Behavioral: Mounted Human-equine Interaction; Behavioral: Unmounted Human-equine Interaction; Behavioral: No-Horse Control |
| Sequence 3: Unmounted, Mounted, No-Horse Control | Other | All participants received all interventions. Participants randomized to Sequence 3 first participated in the unmounted condition, followed by the mounted condition, followed by the no-horse control condition. Receives: Behavioral: Mounted Human-equine Interaction; Behavioral: Unmounted Human-equine Interaction; Behavioral: No-Horse Control |
| Sequence 4: Unmounted, No-horse, Mounted | Other | All participants received all interventions. Participants randomized to Sequence 4 first participated in the unmounted condition, followed by the no-horse control condition, followed by the mounted condition. Receives: Behavioral: Mounted Human-equine Interaction; Behavioral: Unmounted Human-equine Interaction; Behavioral: No-Horse Control |
| Sequence 5: No-Horse Control, Mounted, Unmounted | Other | All participants received all interventions. Participants randomized to Sequence 5 first participated in the no-horse control condition, followed by the mounted condition, followed by the unmounted condition. Receives: Behavioral: Mounted Human-equine Interaction; Behavioral: Unmounted Human-equine Interaction; Behavioral: No-Horse Control |
| Sequence 6: No-Horse Control, Unmounted, Mounted | Other | All participants received all interventions. Participants randomized to Sequence 6 first participated in the no-horse control condition, followed by the unmounted condition, followed by the mounted condition. Receives: Behavioral: Mounted Human-equine Interaction; Behavioral: Unmounted Human-equine Interaction; Behavioral: No-Horse Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrodermal Activity (EDA)
EDA is a well-established indicator of sympathetic nervous system arousal, measured through the skin. We used Shimmer3 EDA monitors donned to participants' wrists to record EDA during the 10-min pre-session baseline, 45-minute horsemanship lesson, and 20-min post-session. Blinded to condition, CS calculated mean response in microsiemens for all five 5-min epochs described above (pre-session; beginning, middle and end of horsemanship lesson; post-session).
Measured: We examined electrodermal activity during a 10-minute pre-session baseline, during the 45-horsemanship lesson (mounted, unmounted, or control), and during a 20-minute post-session recovery.
Heartrate Variability (HRV)
HRV is a well-established indicator of the autonomic nervous system, particularly parasympathetic activity. We used the Shimmer3 electrocardiogram monitor to gather electrocardiogram recordings during the 10-minute pre-session baseline, 45-minute horsemanship lesson (mounted, unmounted, or no-horse control), and 20-minutes post-session recovery. Blinded to condition, CS calculated root mean square of successive differences (RMSDD; a time domain metric of heartrate variability).
Measured: We examined HRV during a 10-minute pre-session baseline, during the 45-horsemanship lesson (mounted, unmounted, or control), and during a 20-minute post-session recovery.
Secondary outcomes (3)
Salivary Cortisol Content
Cortisol is a hormone that reflects stress-related changes in the hypothalamic-pituitary adrenal axis. Saliva collection times occurred at a consistent afternoon time (1:00PM-6:00PM) to avoid unstable AM cortisol concentrations associated with diurnal cortisol rhythms. Participants placed a Salimetrics SalivaBio Children's Swab under their tongue for 1 minute to provide a saliva sample. Samples were stored in a medical grade freezer and shipped to Salimetrics for analysis. Samples were assayed for cortisol using a high sensitivity enzyme immunoassay (Cat. No. 1-3002), with intra-assay and inter-assay coefficients of variation ≤6.00[CP6%.
Measured: Immediately before and 20-minutes after each horsemanship lesson
Irritability and Hyperactivity
We used the Irritability and Hyperactivity subscales of the Aberrant Behavior Checklist Second Edition (ABC-2). The ABC-2 is a caregiver-report questionnaire that measures the presence and intensity of problem behaviors. ABC-2 has strong test-retest reliability (r=0.80 to 0.95), concurrent validity with other measures of behavior, and is frequently used in clinical trials in autism research to characterize participant behavioral regulation.
Measured: 24-48 hours after the horsemanship lesson.
Emotional Dysregulation
The Emotional Dysregulation Inventory is a 30-item measure of emotional dysregulation in autistic youth. The EDI measures emotional reactivity ("intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions")15 and dysphoria ("characterized by anhedonia, sadness, and nervousness"). The EDI was developed using methods from item response theory, has good test-retest reliability in the absence of interventions (mean difference=0.05), and is sensitive to change with intervention (mean difference=1.21). The EDI has concurrent validity with other behavioral measures of emotional dysregulation.
Measured: 24-48 hours after the horsemanship lesson
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start4 Feb 2025
- Primary completion1 Oct 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Model description
- Randomized William's crossover design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- B. Caitlin Peters, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897123
- Sponsor's protocol ID
- HAB24-044
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identifiable data will never be released. After manuscripts have been published, de-identified data used for study analyses will be shared with other interested investigators upon written request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effects of Mounted vs Unmounted Human-Equine Interaction on Physiological and Behavioral Indicators of Self-regulation in Autistic Youth
- ClinicalTrials.gov ID
- NCT07897123
- Acronym / sponsor ID
- HAB24-044
- Conditions
- Autism Spectrum Disorder
- Keywords
- equine-assisted services, emotion regulation, heartrate variability, electrodermal activity, cortisol, human-animal interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
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 how interacting with horses affects autistic children and youth. The main questions it aims to answer are:
- How does interacting with horses affect cortisol, heart-rate variability, and electrodermal activity in autistic children and youth?
- How does interacting with horses affect parent-reported behaviors in autistic children and youth? Researchers will compare riding a horse, brushing a horse, and brushing a pretend stuffed horse to see if there are different effects on autistic children's physiology and behavior.
Participants will
- Attend three different horsemanship lessons on three consecutive weeks. One horsemanship lesson will be mounted (riding), one unmounted (brushing), and one with a pretend horse (brushing).
- Wear monitors on their chest and wrist
- Provide saliva samples
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Randomized William's crossover design
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Mounted, Unmounted, No-Horse Control | Other | Behavioral: Mounted Human-equine Interaction, Behavioral: Unmounted Human-equine Interaction, Behavioral: No-Horse ControlAll participants received all interventions. Participants randomized to Sequence 1 first participated in the mounted condition, followed by the unmounted condition, followed by the no-horse control condition. |
| Sequence 2: Mounted, No-Horse Control, Unmounted | Other | Behavioral: Mounted Human-equine Interaction, Behavioral: Unmounted Human-equine Interaction, Behavioral: No-Horse ControlAll participants received all interventions. Participants randomized to Sequence 2 first participated in the mounted condition, followed by the no-horse control condition, followed by the unmounted condition. |
| Sequence 3: Unmounted, Mounted, No-Horse Control | Other | Behavioral: Mounted Human-equine Interaction, Behavioral: Unmounted Human-equine Interaction, Behavioral: No-Horse ControlAll participants received all interventions. Participants randomized to Sequence 3 first participated in the unmounted condition, followed by the mounted condition, followed by the no-horse control condition. |
| Sequence 4: Unmounted, No-horse, Mounted | Other | Behavioral: Mounted Human-equine Interaction, Behavioral: Unmounted Human-equine Interaction, Behavioral: No-Horse ControlAll participants received all interventions. Participants randomized to Sequence 4 first participated in the unmounted condition, followed by the no-horse control condition, followed by the mounted condition. |
| Sequence 5: No-Horse Control, Mounted, Unmounted | Other | Behavioral: Mounted Human-equine Interaction, Behavioral: Unmounted Human-equine Interaction, Behavioral: No-Horse ControlAll participants received all interventions. Participants randomized to Sequence 5 first participated in the no-horse control condition, followed by the mounted condition, followed by the unmounted condition. |
| Sequence 6: No-Horse Control, Unmounted, Mounted | Other | Behavioral: Mounted Human-equine Interaction, Behavioral: Unmounted Human-equine Interaction, Behavioral: No-Horse ControlAll participants received all interventions. Participants randomized to Sequence 6 first participated in the no-horse control condition, followed by the unmounted condition, followed by the mounted condition. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- ages 6-16 years old
- met the clinical cut-offs for autism on the Autism Diagnostic Observation Schedule Second Edition and Social Communication Questionnaire
- had a nonverbal IQ >40 using the Leiter-3 (CITE)
- scored >10 on the Aberrant Behavior Checklist (CITE) Irritability Scale
- could participate in study procedures (ride and groom a horse, provide saliva sample, don monitors).
Key exclusion criteria (4 listed)
- ridden a horse for ≥10 hours in the past six months
- weighed >200 lbs. per riding center policy
- smoked or were currently using steroids due to their effects on cortisol
- or if a sibling was already enrolled in the study
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 |
|---|---|---|
| Mounted Human-equine InteractionParticipants ride a horse for 45 minutes | Behavioural | Sequence 1: Mounted, Unmounted, No-Horse Control, Sequence 2: Mounted, No-Horse Control, Unmounted, Sequence 3: Unmounted, Mounted, No-Horse Control, Sequence 4: Unmounted, No-horse, Mounted, Sequence 5: No-Horse Control, Mounted, Unmounted, Sequence 6: No-Horse Control, Unmounted, Mounted |
| Unmounted Human-equine InteractionParticipants groom a horse and learn about equine behavior | Behavioural | Sequence 1: Mounted, Unmounted, No-Horse Control, Sequence 2: Mounted, No-Horse Control, Unmounted, Sequence 3: Unmounted, Mounted, No-Horse Control, Sequence 4: Unmounted, No-horse, Mounted, Sequence 5: No-Horse Control, Mounted, Unmounted, Sequence 6: No-Horse Control, Unmounted, Mounted |
| No-Horse ControlParticipants groom a pretend stuffed horse and learn about equine behavior | Behavioural | Sequence 1: Mounted, Unmounted, No-Horse Control, Sequence 2: Mounted, No-Horse Control, Unmounted, Sequence 3: Unmounted, Mounted, No-Horse Control, Sequence 4: Unmounted, No-horse, Mounted, Sequence 5: No-Horse Control, Mounted, Unmounted, Sequence 6: No-Horse Control, Unmounted, Mounted |
Primary outcome
Electrodermal Activity (EDA)
Time frame: We examined electrodermal activity during a 10-minute pre-session baseline, during the 45-horsemanship lesson (mounted, unmounted, or control), and during a 20-minute post-session recovery.
EDA is a well-established indicator of sympathetic nervous system arousal, measured through the skin. We used Shimmer3 EDA monitors donned to participants' wrists to record EDA during the 10-min pre-session baseline, 45-minute horsemanship lesson, and 20-min post-session. Blinded to condition, CS calculated mean response in microsiemens for all five 5-min epochs described above (pre-session; beginning, middle and end of horsemanship lesson; post-session).
Heartrate Variability (HRV)
Time frame: We examined HRV during a 10-minute pre-session baseline, during the 45-horsemanship lesson (mounted, unmounted, or control), and during a 20-minute post-session recovery.
HRV is a well-established indicator of the autonomic nervous system, particularly parasympathetic activity. We used the Shimmer3 electrocardiogram monitor to gather electrocardiogram recordings during the 10-minute pre-session baseline, 45-minute horsemanship lesson (mounted, unmounted, or no-horse control), and 20-minutes post-session recovery. Blinded to condition, CS calculated root mean square of successive differences (RMSDD; a time domain metric of heartrate variability).
3 secondary outcomes
Salivary Cortisol Content
Time frame: Immediately before and 20-minutes after each horsemanship lesson
Irritability and Hyperactivity
Time frame: 24-48 hours after the horsemanship lesson.
Emotional Dysregulation
Time frame: 24-48 hours after the horsemanship lesson
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Identifiable data will never be released. After manuscripts have been published, de-identified data used for study analyses will be shared with other interested investigators upon written request to the principal investigator.
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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.
B. Caitlin 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 Mounted Human-equine Interaction and Unmounted Human-equine Interaction 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 4 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 27 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Electrodermal Activity (EDA) (time frame: We examined electrodermal activity during a 10-minute pre-session baseline, during the 45-horsemanship lesson (mounted, unmounted, or control), and during a 20-minute post-session recovery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.