NCT02301195

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

3.7 years

First QC Date

November 19, 2014

Last Update Submit

October 7, 2021

Conditions

Keywords

Therapeutic Horseback Riding

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in Aberrant Behavior Checklist-Community (Hyperactivity, Lethargy, Stereotypy subscale)

    One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention

  • Change in Social Responsiveness

    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

    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

    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)

    One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention

  • +2 more secondary outcomes

Study Arms (2)

Therapeutic Horseback Riding

EXPERIMENTAL

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

Barn Activity Intervention

ACTIVE COMPARATOR

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

Other: Barn Activity Intervention

Interventions

Inclusion of horses as part of the therapeutic experience

Also known as: Equine-Assisted Activities and Therapies, Animinal-Assisted Intervention
Therapeutic Horseback Riding

Equine-focused educational activities in small group setting without horses

Barn Activity Intervention

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 28273822BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Autism Spectrum DisorderChild Development Disorders, Pervasive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Robin Gabriels, PsyD

    University of Colorado Denver/Children's Hosptial Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

November 25, 2014

Study Start

October 1, 2010

Primary Completion

June 19, 2014

Study Completion

June 19, 2014

Last Updated

October 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share