NCT03493347

Brief Summary

Children with autism spectrum disorders (ASD) often participate in equine-assisted interventions, where practitioners partner with horses to improve the health and well-being of the clients they serve. One of these interventions is equine-assisted occupational therapy (EAOT). The first aim of this study is to assess the effectiveness of EAOT at improving the social, behavioral, and occupational functioning of children with ASD. Second, this study aims to conceptually develop the theory of change that guides how horses are integrated into occupational therapy for children with ASD. Eight children with ASD will participate in 10 weeks of EAOT. The quantitative strand will involve caregivers filling out measures of social functioning, self-regulation, and occupational performance on a weekly basis. Investigators hypothesize children will demonstrate improved performance on these measures during the intervention in comparison to baseline. The qualitative strand will consist of interviews with the providing occupational therapists aimed at understanding the theory behind why the intervention is effective. The results of this study will have implications for children with ASD, their families, and occupational therapists providing services to individuals with ASD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

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

July 24, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

March 26, 2018

Last Update Submit

April 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Analog Scale (VAS) ratings of individualized occupational performance goals

    Parents rate their child's performance on an individualized goal using a sliding scale. The minimum score of 0, indicated on the left of the scale, denotes poor performance, while the maximum score 100, on the right of the scale, denotes excellent performance.

    daily, during baseline and intervention phases (up to 119 days)

Secondary Outcomes (4)

  • Change in Irritability

    Weekly during baseline and intervention phases, up to 18 weeks. Also during 3-month follow-up.

  • Change in Hyperactivity

    Weekly during baseline and intervention phases, up to 18 weeks. Also at 3-month follow up.

  • Change in Social Functioning

    4 Time Points: initial, after 5-7 weeks of no-treatment baseline, after 10 weeks of intervention, and after a 3-month follow-up period.

  • Change in Canadian Occupational Performance Measure

    4 Time Points: initial, after 5-7 weeks of no-treatment baseline, after 10 weeks of intervention, and after a 3-month follow-up period.

Other Outcomes (2)

  • Parent Perceptions of Child's Response to Treatment

    Two time points: 1-2 months after the intervention is complete (January-February 2018) and 5 months after intervention is complete (May 2018)

  • Therapist Clinical Reasoning

    Weekly basis for 10 weeks throughout intervention phase.

Study Arms (1)

Equine-assisted Occupational Therapy

EXPERIMENTAL

All children will receive the Equine-assisted Occupational Therapy (EAOT) intervention, which includes occupational therapy administered in an equine environment. Common intervention activities include grooming, tacking, mounting, and riding the horse.

Behavioral: Equine-assisted Occupational Therapy

Interventions

Occupational therapy provided in an equine environment that includes activities such as groundwork, grooming, tacking, mounting, and riding horses

Equine-assisted Occupational Therapy

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • aged 5-14
  • have an ASD diagnosis by a community provider
  • score ≥15 on the Social Communication Questionnaire
  • score ≥11 on the Aberrant Behavior Checklist-Community
  • meets clinical cut-offs for ASD on the Autism Diagnostic Observation Schedule, Second Edition
  • score ≥55 on the Leiter International Performance Scale, Third Edition
  • can tolerate a helmet
  • can participate in 10-minutes of riding while following safety rules
  • meets physical, mental, and emotional standards set forth by the Professional Association of Therapeutic Horsemanship, International

You may not qualify if:

  • behavioral issues that could interfere with safety
  • hours or more of previous experience with equine-assisted interventions in the last 6 months
  • weight exceeding 200 pounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hearts and Horses Therapeutic Riding Center

Loveland, Colorado, 80537, United States

Location

Related Publications (11)

  • Aman MG, Singh NN, Stewart AW, Field CJ. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Defic. 1985 Mar;89(5):485-91.

    PMID: 3993694BACKGROUND
  • 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.

    PMID: 26088658BACKGROUND
  • Gotham K, Risi S, Dawson G, Tager-Flusberg H, Joseph R, Carter A, Hepburn S, McMAHON W, Rodier P, Hyman SL, Sigman M, Rogers S, Landa R, Spence MA, Osann K, Flodman P, Volkmar F, Hollander E, Buxbaum J, Pickles A, Lord C. A replication of the Autism Diagnostic Observation Schedule (ADOS) revised algorithms. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):642-651. doi: 10.1097/CHI.0b013e31816bffb7.

    PMID: 18434924BACKGROUND
  • Lord, C., Rutter, M., DiLavore, P., RISI, S., Gotham, K., & Bishop, S. (2012). Autism Diagnostic Observation Schedule, Second Edition. Los Angeles, CA: Western Psychological Services.

    BACKGROUND
  • Roid, G. H., & Miller, L. J. (1997). Leiter International Performance Scale- Revised. Wood Dale, IL: Stoelting.

    BACKGROUND
  • Rutter, M., & Bailey, A. (2003). Social Communication Questionnaire. Los Angeles, CA: Western Psychological Services.

    BACKGROUND
  • Tsatsanis KD, Dartnall N, Cicchetti D, Sparrow SS, Klin A, Volkmar FR. Concurrent validity and classification accuracy of the Leiter and Leiter-R in low-functioning children with autism. J Autism Dev Disord. 2003 Feb;33(1):23-30. doi: 10.1023/a:1022274219808.

    PMID: 12708577BACKGROUND
  • Kazdin, A. E. (2011). Single-case research designs: Methods for clinical and applied settings . Oxford University Press.

    BACKGROUND
  • Kratochwill TR, Levin JR. Enhancing the scientific credibility of single-case intervention research: randomization to the rescue. Psychol Methods. 2010 Jun;15(2):124-44. doi: 10.1037/a0017736.

    PMID: 20515235BACKGROUND
  • Byiers BJ, Reichle J, Symons FJ. Single-subject experimental design for evidence-based practice. Am J Speech Lang Pathol. 2012 Nov;21(4):397-414. doi: 10.1044/1058-0360(2012/11-0036). Epub 2012 Oct 15.

    PMID: 23071200BACKGROUND
  • Strauss A., & Corbin, J. (1990). Basics of Qualitative Research. Newbury Park, CA: Sage Publishing.

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Wendy Wood, Ph.D.

    Colorado State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: multiple baseline single case experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research, Temple Grandin Equine Center

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 10, 2018

Study Start

July 24, 2017

Primary Completion

December 18, 2017

Study Completion

December 31, 2018

Last Updated

April 12, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations