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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02301195
Other study ID # 07-1148
Secondary ID 1R01NR012736
Status Completed
Phase N/A
First received
Last updated
Start date October 2010
Est. completion date June 19, 2014

Study information

Verified date October 2021
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 209
Est. completion date June 19, 2014
Est. primary completion date June 19, 2014
Accepts healthy volunteers No
Gender All
Age group 6 Years to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Therapeutic horseback riding
Inclusion of horses as part of the therapeutic experience
Barn Activity Intervention
Equine-focused educational activities in small group setting without horses

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver National Institute of Nursing Research (NINR)

References & Publications (2)

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.jaa — View Citation

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). pii: E256. doi: 10.3390/ijerph14030256. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Aberrant Behavior Checklist-Community (Irritability subscale) 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 Change in Aberrant Behavior Checklist-Community (Hyperactivity, Lethargy, Stereotypy subscale) 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 Change in Social Responsiveness 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
Secondary Change in Systematic Analysis of Language Transcript 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
Secondary Change in Peabody Picture Vocabulary Test-4 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
Secondary Change in Bruininks-Oseretsky Test of Motor Proficiency-2nd Ed. (Short form) 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
Secondary Change In Sensory Integration and Praxis Test (Praxis on verbal command & Postural Praxis subtests) 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
Secondary Change in Vineland Adaptive Behavior Scales Interview 2nd Ed. 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
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