An interventional study of Mounted Human-equine Interaction and Unmounted Human-equine Interaction in Autism Spectrum Disorder, sponsored by Colorado State University. Completed at 1 site in United States. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Colorado State University · Not applicable, Interventional, and Treatment
Among 772 studies in Autism Spectrum Disorder with a site in United States — 165 open to participants now, 204 under way, 9 of them phase 3. Autism Spectrum Disorder · United States.
Among the 772 studies in Autism Spectrum Disorder with a site in United States, this one is the 494th largest by enrollment of the 658 interventional ones that give a count, is one of 32 that started in 2025, is one of 456 with no phase, and was the 770th registered.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's enrollment of 23 is below the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →165 of the 772 studies in Autism Spectrum Disorder with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 297 take children under 18; 92 take healthy volunteers.
This study: 6 Years to 16 Years · all sexes · no healthy volunteers.
The full table on the hub →772 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 52 · Phase 2 117 · Phase 3 33 · Phase 4 16
First in 2004; this study’s year is marked. 32 started in 2025.
Median enrollment 50 across the 658 interventional studies, 131 across the 113 observational. Of the 521 that completed or were terminated, 174 (33%) have results posted.
89 of 772 have an industry lead sponsor. The 10 most frequent:
Colorado State University is the lead sponsor of 117 studies on the registry; 19 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Colorado State University has 4 studies filed under Autism Spectrum Disorder — fewer than ten, so there is no comparison to draw.
68 of the studies in Autism Spectrum Disorder with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06706674Phase 3Intra-Cellular Therapies, Inc.Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients | 2027-06-21 |
| NCT06690398Phase 3Intra-Cellular Therapies, Inc.Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients | 2027-06-21 |
| NCT07670000Natalia PoluektovaMental And Speech Developmental Delay Autism Spectrum-Type Behavioral Disorder | 2026-11 |
| NCT04242355Yale UniversityTranscranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder | 2026-12 |
| NCT06059352Loma Linda UniversitySleep and Central Auditory Processing Disorder in Autism Spectrum Disorder | 2026-12 |
Among the 772 studies in Autism Spectrum Disorder with a site in United States, from their registry updates:
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:
Participants will
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Mounted Human-equine Interaction · Behavioral: Unmounted Human-equine Interaction · Behavioral: No-Horse Control
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.
Behavioral: Mounted Human-equine Interaction · Behavioral: Unmounted Human-equine Interaction · Behavioral: No-Horse Control
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.
Behavioral: Mounted Human-equine Interaction · Behavioral: Unmounted Human-equine Interaction · Behavioral: No-Horse Control
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.
Behavioral: Mounted Human-equine Interaction · Behavioral: Unmounted Human-equine Interaction · Behavioral: No-Horse Control
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.
Behavioral: Mounted Human-equine Interaction · Behavioral: Unmounted Human-equine Interaction · Behavioral: No-Horse Control
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.
Behavioral: Mounted Human-equine Interaction · Behavioral: Unmounted Human-equine Interaction · Behavioral: No-Horse Control
Participants ride a horse for 45 minutes
Participants groom a horse and learn about equine behavior
Participants groom a pretend stuffed horse and learn about equine behavior
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).
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.
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).
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.
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%.
Time frame: 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.
Time frame: 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.
Time frame: 24-48 hours after the horsemanship lesson
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 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. Once shared, the investigator will have access to the data indefinitely.
Access criteria: The de-identified dataset used for the final data analyses will be shared upon written request by qualified investigator (PhD with publication record related to this area of study). The principle investigator will email an excel file containing de-identified data and supporting documents (study protocol, statistical analysis plan, informed consent form) to qualified investigators upon request.
No publications or documents are linked to this record.
Ran from Feb 2025 to primary completion in Oct 2025, 7 months.
Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 7 months is below that.
Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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