Autism Spectrum DisorderNCT02301195
Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder
A study testing Therapeutic horseback riding and Barn Activity Intervention in people with Autism Spectrum Disorder and Child Development Disorders, Pervasive, run by University of Colorado, Denver.
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… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Autism Spectrum Disorder, Child Development Disorders, Pervasive
- What is being tested?
- Therapeutic horseback riding and Barn Activity Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to 19 Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Therapeutic horseback riding, Barn Activity Intervention
- Keywords
- Therapeutic Horseback Riding
- Medical subject headings
- Autism Spectrum Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic horseback ridingOther
Also called Equine-Assisted Activities and Therapies, Animinal-Assisted Intervention
Inclusion of horses as part of the therapeutic experience
Barn Activity InterventionOther
Equine-focused educational activities in small group setting without horses
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Barn Activity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
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.
Measured: 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
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
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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.
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.
Measured: One month pre-intervention, weekly for 10 weeks during intervention, and one month post intervention, and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startOct 2010
- Primary completion19 Jun 2014
- Study completion19 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Robin Gabriels, PsyD, Principal investigator, University of Colorado Denver/Children's Hosptial Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301195
- Sponsor's protocol ID
- 07-1148
- Other IDs
- 1R01NR012736
- Status last verified
- Oct 2021
- First submitted
- 19 Nov 2014
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28273822Gabriels 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.
PubMed 26088658Pan 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.
PubMed 30693284Gabriels 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.
PubMed 30062099
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effects of Therapeutic Horseback Riding on School-Age Children and Adolescents With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02301195
- Acronym / sponsor ID
- 07-1148
- Keywords
- Therapeutic Horseback Riding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Oct 2010 (actual)
- Primary completion
- 19 Jun 2014 (actual)
- Study completion
- 19 Jun 2014 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Horseback Riding | Experimental | Other: Therapeutic horseback ridingTen-weekly one-hour manualized small group Therapeutic Horseback Riding intervention led by certified THR instructor.THR intervention taught riding and horsemanship skills. |
| Barn Activity Intervention | Active comparator | Other: Barn Activity InterventionTen-weekly one-hour manualized small group Barn Activity Intervention led by THR instructor, teaching horsemanship skills without horses present. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic horseback ridingAlso: Equine-Assisted Activities and Therapies, Animinal-Assisted InterventionInclusion of horses as part of the therapeutic experience | Other | Therapeutic Horseback Riding |
| Barn Activity InterventionEquine-focused educational activities in small group setting without horses | Other | Barn Activity Intervention |
Primary outcome
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).
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Background: PubMed 28273822Petty 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 publication: PubMed 26088658Gabriels 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.
- Derived from this study: PubMed 30693284Pan 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.
- Derived from this study: PubMed 30062099Gabriels 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Gabriels, PsyD principal investigator
University of Colorado Denver/Children's Hosptial Colorado
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic horseback riding and Barn Activity Intervention in people with Autism Spectrum Disorder and Child Development Disorders, Pervasive, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301195, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.