Autism Spectrum Disorder, Mental Disorders
Conditions
Keywords
human-animal intervention, physiology, mechanisms of action, children, adolescents, emotion regulation, cortisol, heart rate, electrodermal activity
Brief 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 the intervention.
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).
Interventions
Sponsors
University of Colorado, Denver
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Speech therapist evaluator will be blinded to participants' intervention condition assignment
Intervention model description
Randomized Controlled Trial assigned to one of 3 groups: Therapeutic Horseback Riding group Barn Activity group (no-horse control) Waitlist Hybrid group
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aberrant Behavior Checklist-Community (ABC-C) - Baseline | 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. |
| Aberrant Behavior Checklist-Community (ABC-C) - End of Treatment | 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. |
| Aberrant Behavior Checklist-Community (ABC-C) - 6 Months Post Treatrment | 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. |
| Social Responsiveness Scale™, Second Edition - Baseline | 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. |
| Social Responsiveness Scale™, Second Edition - End of Treatment | 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. |
| Social Responsiveness Scale™, Second Edition - 6 Months Post Treatment | 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. |
| Emotion Dysregulation Inventory (EDI) - Baseline | 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. |
| Emotion Dysregulation Inventory (EDI) - End of Treatment | 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. |
| Emotion Dysregulation Inventory (EDI) - 6 Months Post Treatment | 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. |
| Systematic Analysis of Language Transcripts (SALT) - Baseline | 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. |
| Systematic Analysis of Language Transcripts (SALT) - End of Treatment | 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. |
| Systematic Analysis of Language Transcripts (SALT) - 6 Months Post Treatment | 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. |
| World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - Baseline | 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. |
| World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - End of Treatment | 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. |
| World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - 6 Months Post Treatment | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobin L Gabriels, Psy.D.
University of Colorado Anzchutz Medical Campus
Participant flow
Recruitment details
Study recruitment period began Fall 2020 and concluded Winter 2024. The recruitment process involved sending IRB-approved study information fliers to community agencies serving ASD youth in the two study site states (Colorado and Maine). This recruitment effort was limited to agencies located near each of the state's riding center intervention sites (i.e., Colorado- Denver and north to the state's border and including southern Wyoming; Maine- Portland and surrounding area.)
Pre-assignment details
The following lists reasons enrolled participants were excluded prior to group assignment: * Nonverbal IQ standard score less than 40. * Not meeting criteria for an ASD diagnosis * Not meeting criteria for at least one psychiatric diagnosis (i.e. mood, anxiety, ADHD) * Not receiving medical screening clearance by a medical physician * Having medical or behavioral issues that would prevent participation * Exceeding riding centers' horse safety policy for weight limit.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 10.3 years STANDARD_DEVIATION 2.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Nonverbal IQ | 100.8 units on a scale STANDARD_DEVIATION 22.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 131 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 67 | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 2 / 74 | 1 / 67 | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 74 | 0 / 67 | 0 / 28 | 0 / 28 |
Outcome results
None listed