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Completed

NCT Number: NCT04606966

Physiological Mechanisms of Therapeutic Horseback Riding Intervention Effects in a Psychiatric Population of ASD Youth

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Therapeutic horseback riding

Other

Horse therapy

Other names: Equine Assisted Activity

Barn Activity

Other

Horsemanship group

Other names: No Horse control

Hybrid

Other

Ground and riding activities

Other names: Equine Assisted Activity

Primary outcomes

  1. Aberrant Behavior Checklist-Community (ABC-C) - Baseline

    Time frame: 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.

  2. Aberrant Behavior Checklist-Community (ABC-C) - End of Treatment

    Time frame: 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.

  3. Aberrant Behavior Checklist-Community (ABC-C) - 6 Months Post Treatrment

    Time frame: 6 months post intervention

    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.

  4. Social Responsiveness Scale™, Second Edition - Baseline

    Time frame: 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 2 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.

  5. Social Responsiveness Scale™, Second Edition - End of Treatment

    Time frame: 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.

  6. Social Responsiveness Scale™, Second Edition - 6 Months Post Treatment

    Time frame: 6 months post intervention

    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.

  7. Emotion Dysregulation Inventory (EDI) - Baseline

    Time frame: 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.

  8. Emotion Dysregulation Inventory (EDI) - End of Treatment

    Time frame: 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.

  9. Emotion Dysregulation Inventory (EDI) - 6 Months Post Treatment

    Time frame: 6 months post intervention

    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.

  10. Systematic Analysis of Language Transcripts (SALT) - Baseline

    Time frame: 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.

  11. Systematic Analysis of Language Transcripts (SALT) - End of Treatment

    Time frame: 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.

  12. Systematic Analysis of Language Transcripts (SALT) - 6 Months Post Treatment

    Time frame: 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.

  13. World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - Baseline

    Time frame: 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.

  14. World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - End of Treatment

    Time frame: 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.

  15. World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - 6 Months Post Treatment

    Time frame: 6 months post intervention

    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.

Other outcomes

  1. Salivary Cortisol - Baseline Baseline

    Time frame: Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).

    Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before (i.e., "Pre-session") and 20 minutes after (i.e., "Post-Session) each THR or BA group session weeks 1-10. Salivary cortisol collected pre- and -post intervention activities were analyzed separately.

  2. Salivary Cortisol - Mid-Point

    Time frame: Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)

    Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10. Salivary cortisol collected pre- and -post intervention activities were analyzed.

  3. Salivary Cortisol - End of Treatment

    Time frame: Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).

    Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10. Salivary cortisol collected pre- and -post intervention activities were analyzed.

  4. Heart Rate Variability - Baseline

    Time frame: Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).

    The Shimmer3 cardiac (ECG) monitor was used in this study. This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion. The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively. It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125 It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing. Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson. Unit of measure is ms log-10 transformed.

  5. Heart Rate Variability - Mid-point

    Time frame: Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).

    The Shimmer3 cardiac (ECG) monitor was used in this study. This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion. The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively. It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125 It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing. Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson. Unit of measure is ms log-10 transformed.

  6. Heart Rate Variability - End of Treatment

    Time frame: Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).

    The Shimmer3 cardiac (ECG) monitor was used in this study. This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion. The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively. It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125 It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing. Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson. Unit of measure is ms log-10 transformed.

  7. Electrodermal Activity -- Baseline

    Time frame: Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).

    The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes. As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used. EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range. Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile. The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry. Participants' Shimmer3 EDA assessments were measured during the intervention lesson. Unit of measure is microsiemens.

  8. Electrodermal Activity - Mid-point

    Time frame: Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).

    The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes. As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used. EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range. Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile. The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry. Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson. Unit of measure is microsiemens.

  9. Electrodermal Activity - End of Treatment

    Time frame: Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).

    The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes. As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used. EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range. Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile. The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry. Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson. Unit of measure is microsiemens.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Baylor University
  • Boston Children's Hospital
  • Colorado State University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Hearts and Horses Therapeutic Riding Center
  • Maine Health/Spring Harbor Hospital
  • Riding To The Top Therapeutic Riding Center
  • Salimetrics, LLC
  • University of Pittsburgh

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2020
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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