Autism Spectrum DisorderNCT04606966
Physiological Mechanisms of Therapeutic Horseback Riding Intervention Effects in a Psychiatric Population of ASD Youth
A study testing Therapeutic Horseback Riding, Barn Activity and Hybrid in people with Autism Spectrum Disorder and Mental Disorders, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
This randomized control trial (RCT) seeks to assess the mechanisms underlying Therapeutic Horseback Riding's (THR) previously observed significant positive effects on ASD youth, particularly those with co-occurring psychiatric disorders, and to refine information on the durability, dose and sub-population effects of… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Mental Disorders
- What is being tested?
- Therapeutic Horseback Riding, Barn Activity and Hybrid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Dec 2020to 22 Feb 2025
- Phase
- Interventional
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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- documented ASD diagnosis and a co-occurring psychiatric disorder
- ABC Irritability subscale score ≥8
- Leiter-III Nonverbal IQ ≥ 40
- meet Symptom Criterion score (minimum number of symptoms necessary for a DSM-V (mood, anxiety, or ADHD diagnosis) on CASI-5)
- meet ASD cut-offs on the SCQ (≥ 11) and on ADOS-2
- Only one child with ASD per family to maintain independent observations
- a consistent caregiver (i.e., parent or legal guardian) to complete study outcome measures
Who cannot join
- medical or behavioral issues that prevent participation
- ward of the state
- judged during riding center screen to have significant riding experience
- smoking or regular use of oral, inhaled, or topical steroids on a regular basis, factors known to affect cortisol levels
- Participants weighing 200 pounds or greater will be excluded due to the riding center's safety policies
- Participants will not be allowed to begin baseline assessments until at least six months have passed from the time they last engaged in mounted EAAT, given pilot evidence for the six-month maintenance of THR effects.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80218
Maine Health
Portland, Maine, 04102
About this study
Official title: Physiological Mechanisms of Action Relating to Immediate and Long-term Therapeutic Horseback Riding Intervention Effects in a Psychiatric Population of Youth With Autism Spectrum Disorder
This randomized control trial (RCT) seeks to assess the mechanisms underlying Therapeutic Horseback Riding's (THR) previously observed significant positive effects on ASD youth, particularly those with co-occurring psychiatric disorders, and to refine information on the durability, dose and sub-population effects of the intervention.
Read the detailed description
This randomized control trial (RCT) will test the hypothesis that physiological response patterns of salivary cortisol, cardiovascular, and electrodermal activity account for our previously observed significant outcomes (i.e., reduced irritability and hyperactivity, and improved social and communication), and additional outcomes (emotion regulation caregiver quality of life and crisis mental health care usage), in youth ages 6-16 yrs. with ASD and co-occurring psychiatric diagnoses randomized to a 10-week manualized THR intervention compared to a no-horse Barn Activity (BA) control (Aim 1). We will evaluate the durability of Aim 1 outcomes in the THR group compared to the BA control group six-months after the intervention period (Aim 2). Finally, we will explore dose and sub-population effects of THR and BA interventions by comparing effect size differences in THR and BA groups to (a) a 10-week wait-list control group; (b) a Hybrid intervention group (five weeks BA followed by five weeks THR); and (c) a subsample of the THR study population randomized following psychiatric hospitalization (Aim 3).
- Conditions
- Autism Spectrum Disorder, Mental Disorders
- Being tested
- Therapeutic Horseback Riding, Barn Activity, Hybrid
- Keywords
- human-animal intervention, physiology, mechanisms of action, children, adolescents, emotion regulation, cortisol, heart rate, electrodermal activity
- Medical subject headings
- Autism Spectrum Disorder, Mental Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Horseback RidingOther
Also called Equine Assisted Activity
Horse therapy
Barn ActivityOther
Also called No Horse control
Horsemanship group
HybridOther
Also called Equine Assisted Activity
Ground and riding activities
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Horseback Riding | Experimental | This Arm is a 10 week one hour small group (2-4 participants) led by a THR instructor. The group will include a 45-minute mounted activity to learn horsemanship skills as outlined in the study's THR manual, . Group times will be between 1:00-5:00 PM to collect salivary cortisol. Weekly, participants will follow a consistent routine of wearing both their electro dermal activity and heart rate monitoring devices, sit at a group art table before class, after this, study personnel will instruct participants to place the 10cm long foam swab rod under their tongue for one minute while watching a 1-minute timer. Participants will then don their riding helmets and enter the riding arena. Each week after conclusion of the THR intervention, participants will again sit with their group at an art table for 5 minutes followed by doing another saliva sample. Receives: Other: Therapeutic Horseback Riding |
| Barn Activity | Active comparator | This Arm is a 10 week one hour small group (2-4 participants) led by a THR instructor and co-led by a mental health or Occupational therapy provider. Participants will have one assigned volunteer and will have no physical contact with horses at the riding center, just view horses from a distance. There will be a life-sized stuffed toy horse for hands-on learning related to the weekly topic per the BA study manual. Group times will be between 1:00-5:00 PM to collect salivary cortisol. Weekly, participants will follow a consistent routine of wearing both their electro dermal activity and heart rate monitoring devices, sit at a group art table before class, after this, study personnel will instruct participants to place the 10cm long foam swab rod under their tongue for one minute while watching a 1-minute timer. Each week after conclusion of the BA intervention, participants will again sit with their group at an art table for 5 minutes followed by doing another saliva sample. Receives: Other: Barn Activity |
| Waitlist | No intervention | Those assigned to the waitlist group will not have any horse-related intervention during a 10-week waiting period. Following this waiting period and the completion of post assessments, participants in this condition will begin a Hybrid group (see Hybrid Arm) |
| Hybrid | Experimental | Participants completing the Wait list Arm and post assessments, will begin a Hybrid group between 1:00-5:00 PM. The group consists of a 5- week 1 -hour BA small group (2-4 participants) led by a THR instructor and co-led by a mental health counselor or OT. Participants will have one assigned volunteer and have no physical contact with horses at the riding center, just view horses at a distance. There will be a life-sized stuffed horse for hands-on learning weekly topics per BA study manual. Group. Then, participants will complete 5-weeks of Therapeutic Horseback Riding small group (2-4 participants) led by a THR instructor. The group will include a 45-minute mounted activity to learn horsemanship skills followed by a 15-minute unmounted horse grooming and tacking activity per THR manual. Participants will have an assigned horse and volunteer(s). Receives: Other: Hybrid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist-Community (ABC-C) - Baseline
The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e. Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale. THIS MEASURE DOES NOT GENERATE A TOTAL SCORE. Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems. The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
Measured: Baseline
Aberrant Behavior Checklist-Community (ABC-C) - End of Treatment
The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e. Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale. THIS MEASURE DOES NOT GENERATE A TOTAL SCORE. Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems. The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
Measured: End of Treatment
Aberrant Behavior Checklist-Community (ABC-C) - 6 Months Post Treatrment
The ABC is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e. Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale. THIS MEASURE DOES NOT GENERATE A TOTAL SCORE. Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems. The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
Measured: 6 months post intervention
Social Responsiveness Scale™, Second Edition - Baseline
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD. The Social Responsiveness Scale™-Second Edition generates raw scores and t-scores for both the combined total score as well as for each of the 5 subscales (social awareness, social cognition, social communication, social motivation, and restricted/repetitive behaviors). NOTE: THIS STUDY USED THE RAW SCORES FOR ANALYSES. The combined Social Responsiveness Scale™-Second Edition total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134. HIGHER SCORES ON THIS SCALE INDICATE WORSE OUTCOMES. The Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19. HIGHER SCORES ON THIS SUBSCALE INDICATE WORSE OUTCOMES. The Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28. HIGHER SCORES ON THIS SUBSCALE.
Measured: Baseline
Social Responsiveness Scale™, Second Edition - End of Treatment
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD. THIS STUDY USED RAW SCORES FOR ANALYSES. FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME. Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134. Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19. Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of g 28. Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26. Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
Measured: End of Treatment
Social Responsiveness Scale™, Second Edition - 6 Months Post Treatment
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD. THIS STUDY USED RAW SCORES FOR ANALYSES. FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME. Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134. Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19. Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28. Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26. Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
Measured: 6 months post intervention
Emotion Dysregulation Inventory (EDI) - Baseline
The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately. The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions. The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness. Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here). The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
Measured: Baseline
Emotion Dysregulation Inventory (EDI) - End of Treatment
The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately. The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions. The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness. Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here). The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
Measured: End of Treatment
Emotion Dysregulation Inventory (EDI) - 6 Months Post Treatment
The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately. The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions. The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness. For each scale (Reactivity and Dysphoria), raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here). The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
Measured: 6 months post intervention
Systematic Analysis of Language Transcripts (SALT) - Baseline
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD. The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database. A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment. Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
Measured: Baseline
Systematic Analysis of Language Transcripts (SALT) - End of Treatment
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD. The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database. A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment. Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
Measured: End of Treatment
Systematic Analysis of Language Transcripts (SALT) - 6 Months Post Treatment
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD. The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database. A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment. Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
Measured: 6 months post treatment
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - Baseline
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale. Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here. Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
Measured: Baseline
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - End of Treatment
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale. Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here. Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
Measured: End of Treatment
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - 6 Months Post Treatment
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale. Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start22 Dec 2020
- Primary completion22 Feb 2025
- Study completion22 Feb 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.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Randomized Controlled Trial assigned to one of 3 groups: Therapeutic Horseback Riding group Barn Activity group (no-horse control) Waitlist Hybrid group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Maine Health/Spring Harbor Hospital, Riding To The Top Therapeutic Riding Center, Hearts and Horses Therapeutic Riding Center, Salimetrics, LLC, Baylor University, University of Pittsburgh, Colorado State University, Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Robin L Gabriels, Psy.D., Principal investigator, University of Colorado Anzchutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606966
- Sponsor's protocol ID
- 19-1962
- Other IDs
- 1R01HD097693-01A1
- Status last verified
- Jul 2026
- First submitted
- 15 Oct 2020
- Last updated
- 18 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No