- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02301195
Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder
October 7, 2021 updated by: University of Colorado, Denver
Measuring the Effects of Therapeutic Horseback Riding on School-Age Children and Adolescents With Autism Spectrum Disorders
This study is being carried out to learn more about the effects of Therapeutic Horseback Riding (THR) for children and adolescents with an autism spectrum disorder (ASD).
This treatment is very popular and horseback riding for children and adults with disabilities has been used as a form of therapy in the United States for over forty years.
However, very little research has been done to find out whether or not THR is effective as a therapy for children with an ASD.
This study is being done to see if THR will improve the agitation behaviors, coordination, and communication skills of children and adolescents with an ASD.
This study is also being done to find out if the horse is necessary for children and adolescents with an ASD to improve.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study expands previous preliminary equine-assisted intervention research, including the authors' 10-week Therapeutic horseback riding (THR) intervention pilot, by evaluating the effectiveness of therapeutic horseback riding (THR) on self-regulation, socialization, communication, adaptive, and motor behaviors in children with autism spectrum disorder (ASD).
Method: One hundred and twenty-seven participants (ages 6-16 years) were randomized by nonverbal IQ standard scores (< 85 or > 85) to one of two 10-week small groups: THR intervention; or barn activity (BA) control group without horses.
Both interventions used similar methods, and the fidelity of the THR intervention was monitored.
Participants were evaluated within one month pre- and post-intervention by raters blind to intervention conditions and caregiver questionnaires.
Weekly during the intervention, caregivers rated participants' behaviors during the preceding week.
Study Type
Interventional
Enrollment (Actual)
209
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Score ≥ 11 on the irritability and stereotypy subscales of Aberrant Behavior Checklist-Community
- Nonverbal IQ ≥ 40
- Diagnosis of autistic or Asperger's disorder prior to study admission from a psychologist or psychiatrist in the community
- Meets diagnostic cut-off scores for autism spectrum on the Social Communication Questionnaire (SCQ) (> 15) and on the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
- Meets DSM-IV-TR criteria for autistic or Asperger's disorder based on diagnostic information gathered for this study from the SCQ, ADOS-2, and Repetitive Behavior Scales-Revised (RBS-R)
- Absence of significant vision, hearing, or motor impairments
- Absence of genetic disorders known to be causative of or potentially resulting in a phenotype similar to autism: Fragile X Syndrome, Landau Kleffner, Rett Syndrome, Childhood Disintegrative Disorder, or tuberous sclerosis, based on screening by clinical staff
- In the event that a family has more than one child diagnosed with autism or Asperger's, only one child per family will be included in the study that meets other study inclusion criteria to maintain independent observation of the participant
- Must have a consistent school-based teacher (vs. a parent who is providing home schooling) willing to complete the ABC-C form twice during the study for each participant, as well as a parent/guardian who is willing to complete the designated outcome parent/guardian report forms during the study
Exclusion Criteria:
- Child has a medical or psychiatric disorder or behavioral issue that would prevent participation
- Child has had no more than 2 hours exposure to EAATs (equine assisted activities and therapies) in the past 6 months and is judged, during the evaluation at Hearts & Horses by the research site coordinator, to not have significant riding experience (an individual with significant riding experience is defined here as one for whom the beginner curriculum would not be appropriately challenging), as the curriculum is designed for beginner riders
- The child has a history of animal abuse or phobia to horses
- Wards of the State
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Therapeutic Horseback Riding
Ten-weekly one-hour manualized small group Therapeutic Horseback Riding intervention led by certified THR instructor.THR intervention taught riding and horsemanship skills.
|
Inclusion of horses as part of the therapeutic experience
Other Names:
|
Active Comparator: Barn Activity Intervention
Ten-weekly one-hour manualized small group Barn Activity Intervention led by THR instructor, teaching horsemanship skills without horses present.
|
Equine-focused educational activities in small group setting without horses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Aberrant Behavior Checklist-Community (Irritability subscale)
Time Frame: One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
The investigators hypothesize that social communication behaviors will increase and subjects will show a decrease in aberrant behaviors from pre to post THR lesson and over the course of the 10-week intervention, as observed in the brief periods captured (e.g., estimated 4 minutes before and 4 minutes after each THR lesson).
|
One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Aberrant Behavior Checklist-Community (Hyperactivity, Lethargy, Stereotypy subscale)
Time Frame: One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
The investigators hypothesize that social communication behaviors will increase and subjects will show a decrease in aberrant behaviors from pre to post THR lesson and over the course of the 10-week intervention, as observed in the brief periods captured (e.g., estimated 4 minutes before and 4 minutes after each THR lesson).
|
One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Change in Social Responsiveness
Time Frame: One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Subjects in the THR group will have greater improvements in socialization, as measured by a parent/guardian report form, the Social Responsiveness Scale, than the control group.
|
One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Change in Systematic Analysis of Language Transcript
Time Frame: One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Subjects in the THR group will have greater improvement on communication, as measured by blinded speech therapist assessment using the Peabody Picture Vocabulary Test and the Systematic Analysis of Language Transcripts
|
One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Change in Peabody Picture Vocabulary Test-4
Time Frame: One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Subjects in the THR group will have greater improvement on communication, as measured by blinded speech therapist assessment using the Peabody Picture Vocabulary Test and the Systematic Analysis of Language Transcripts, as well as by parent interview utilizing the Vineland Adaptive Behavior Scales-II communication subscale, than the control group.
|
One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Change in Bruininks-Oseretsky Test of Motor Proficiency-2nd Ed. (Short form)
Time Frame: One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Subjects in the THR group will have greater improvement on motor functioning (i.e., physical coordination, stability, and motor planning/praxis), as measured by blinded Occupational Therapists assessment utilizing the Bruininks-Oseretsky Test of Motor Proficiency and the Sensory Integration and Praxis Test, than the control group.
|
One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Change In Sensory Integration and Praxis Test (Praxis on verbal command & Postural Praxis subtests)
Time Frame: One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Subjects in the THR group will have greater improvement on motor functioning (i.e., physical coordination, stability, and motor planning/praxis), as measured by blinded Occupational Therapists assessment utilizing the Bruininks-Oseretsky Test of Motor Proficiency and the Sensory Integration and Praxis Test, than the control group.
|
One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Change in Vineland Adaptive Behavior Scales Interview 2nd Ed.
Time Frame: One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
subjects in the THR group will have statistically non-significant changes in their post-intervention scores on communication, as measured by blinded speech therapist assessment using the Peabody Picture Vocabulary Test and the Systematic Analysis of Language Transcripts, as well as by parent interview utilizing the Vineland Adaptive Behavior Scales-II communication subscale.
|
One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robin Gabriels, PsyD, University of Colorado Denver/Children's Hosptial Colorado
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Petty JD, Pan Z, Dechant B, Gabriels RL. Therapeutic Horseback Riding Crossover Effects of Attachment Behaviors with Family Pets in a Sample of Children with Autism Spectrum Disorder. Int J Environ Res Public Health. 2017 Mar 3;14(3):256. doi: 10.3390/ijerph14030256.
- Gabriels RL, Pan Z, Dechant B, Agnew JA, Brim N, Mesibov G. Randomized Controlled Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2015 Jul;54(7):541-9. doi: 10.1016/j.jaac.2015.04.007. Epub 2015 May 5.
- Pan Z, Granger DA, Guerin NA, Shoffner A, Gabriels RL. Replication Pilot Trial of Therapeutic Horseback Riding and Cortisol Collection With Children on the Autism Spectrum. Front Vet Sci. 2019 Jan 14;5:312. doi: 10.3389/fvets.2018.00312. eCollection 2018.
- Gabriels RL, Pan Z, Guerin NA, Dechant B, Mesibov G. Long-Term Effect of Therapeutic Horseback Riding in Youth With Autism Spectrum Disorder: A Randomized Trial. Front Vet Sci. 2018 Jul 16;5:156. doi: 10.3389/fvets.2018.00156. eCollection 2018.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2010
Primary Completion (Actual)
June 19, 2014
Study Completion (Actual)
June 19, 2014
Study Registration Dates
First Submitted
November 19, 2014
First Submitted That Met QC Criteria
November 21, 2014
First Posted (Estimate)
November 25, 2014
Study Record Updates
Last Update Posted (Actual)
October 8, 2021
Last Update Submitted That Met QC Criteria
October 7, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-1148
- 1R01NR012736 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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