ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02301195
Recruitment Status : Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Child Development Disorders, Pervasive Other: Therapeutic horseback riding Other: Barn Activity Intervention Not Applicable

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  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Measuring the Effects of Therapeutic Horseback Riding on School-Age Children and Adolescents With Autism Spectrum Disorders
Study Start Date : October 2010
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.
Other: Therapeutic horseback riding
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.
Other: Barn Activity Intervention
Equine-focused educational activities in small group setting without horses




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301195


Sponsors and Collaborators
University of Colorado, Denver
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Robin Gabriels, PsyD University of Colorado Denver/Children's Hosptial Colorado

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02301195     History of Changes
Other Study ID Numbers: 07-1148
1R01NR012736 ( U.S. NIH Grant/Contract )
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by University of Colorado, Denver:
Therapeutic Horseback Riding

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Developmental Disabilities
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders