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

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:
  • Equine-Assisted Activities and Therapies
  • Animinal-Assisted Intervention
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.

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.

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

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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