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

Primary Purpose

Autism Spectrum Disorder, Child Development Disorders, Pervasive

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic horseback riding
Barn Activity Intervention
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring Therapeutic Horseback Riding

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Therapeutic Horseback Riding

    Barn Activity Intervention

    Arm Description

    Ten-weekly one-hour manualized small group Therapeutic Horseback Riding intervention led by certified THR instructor.THR intervention taught riding and horsemanship skills.

    Ten-weekly one-hour manualized small group Barn Activity Intervention led by THR instructor, teaching horsemanship skills without horses present.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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).
    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.
    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
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    November 19, 2014
    Last Updated
    October 7, 2021
    Sponsor
    University of Colorado, Denver
    Collaborators
    National Institute of Nursing Research (NINR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02301195
    Brief Title
    Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder
    Official Title
    Measuring the Effects of Therapeutic Horseback Riding on School-Age Children and Adolescents With Autism Spectrum Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2010 (Actual)
    Primary Completion Date
    June 19, 2014 (Actual)
    Study Completion Date
    June 19, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    Collaborators
    National Institute of Nursing Research (NINR)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder, Child Development Disorders, Pervasive
    Keywords
    Therapeutic Horseback Riding

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    209 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapeutic Horseback Riding
    Arm Type
    Experimental
    Arm Description
    Ten-weekly one-hour manualized small group Therapeutic Horseback Riding intervention led by certified THR instructor.THR intervention taught riding and horsemanship skills.
    Arm Title
    Barn Activity Intervention
    Arm Type
    Active Comparator
    Arm Description
    Ten-weekly one-hour manualized small group Barn Activity Intervention led by THR instructor, teaching horsemanship skills without horses present.
    Intervention Type
    Other
    Intervention Name(s)
    Therapeutic horseback riding
    Other Intervention Name(s)
    Equine-Assisted Activities and Therapies, Animinal-Assisted Intervention
    Intervention Description
    Inclusion of horses as part of the therapeutic experience
    Intervention Type
    Other
    Intervention Name(s)
    Barn Activity Intervention
    Intervention Description
    Equine-focused educational activities in small group setting without horses
    Primary Outcome Measure Information:
    Title
    Change in Aberrant Behavior Checklist-Community (Irritability subscale)
    Description
    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).
    Time Frame
    One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
    Secondary Outcome Measure Information:
    Title
    Change in Aberrant Behavior Checklist-Community (Hyperactivity, Lethargy, Stereotypy subscale)
    Description
    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).
    Time Frame
    One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
    Title
    Change in Social Responsiveness
    Description
    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.
    Time Frame
    One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
    Title
    Change in Systematic Analysis of Language Transcript
    Description
    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
    Time Frame
    One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
    Title
    Change in Peabody Picture Vocabulary Test-4
    Description
    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.
    Time Frame
    One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
    Title
    Change in Bruininks-Oseretsky Test of Motor Proficiency-2nd Ed. (Short form)
    Description
    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.
    Time Frame
    One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
    Title
    Change In Sensory Integration and Praxis Test (Praxis on verbal command & Postural Praxis subtests)
    Description
    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.
    Time Frame
    One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
    Title
    Change in Vineland Adaptive Behavior Scales Interview 2nd Ed.
    Description
    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.
    Time Frame
    One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robin Gabriels, PsyD
    Organizational Affiliation
    University of Colorado Denver/Children's Hosptial Colorado
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28273822
    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):256. doi: 10.3390/ijerph14030256.
    Results Reference
    background
    PubMed Identifier
    26088658
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    30693284
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    30062099
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4475278
    Description
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    Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder

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