NCT04482088

Brief Summary

The purpose of this study is to learn about occupational therapy for youth with autism in a traditional clinic environment, and in an equine environment. 20 youth with autism will participate in 10 weeks of occupational therapy in a clinic environment, followed by 10 weeks of occupational therapy in an equine environment. Caregivers will complete online surveys about their child's behavior. Occupational therapists and other stakeholders will provide feedback about the interventions. The therapy sessions that involve horses will be videotaped, and a researcher will look at the behaviors of the horses involved in the intervention. We will use the results of this study to improve the quality of both interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2021

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

July 16, 2020

Last Update Submit

August 19, 2022

Conditions

Keywords

occupational therapyequine-assisted serviceshippotherapy

Outcome Measures

Primary Outcomes (1)

  • Change in Goal Performance using Goal Attainment Scaling

    Performance on individualized occupational performance goals

    10 weeks

Secondary Outcomes (5)

  • Change in Aberrant Behavior Checklist- Community

    10 weeks

  • Change in Social Responsiveness Scale, Second Edition

    10 weeks

  • Change in Pediatric Disability Inventory Computer Adaptive Test for Autism Spectrum Disorders

    10 weeks

  • Change in World Health Organization Quality of Life- BREF

    10 weeks

  • Change in Emotional Dysregulation Inventory

    10 weeks

Study Arms (1)

OTC & OTEE

EXPERIMENTAL

Every participant will receive 10 weeks of occupational therapy in a clinic environment (OTC) followed by 10 weeks of occupational therapy in an equine environment

Behavioral: Occupational Therapy in an Equine EnvironmentBehavioral: Occupational Therapy in a Clinic (OTC)

Interventions

10 weeks of occupational therapy in an equine environment aimed at improving individual goals related to self-regulation, social communication, and play

Also known as: OTEE-HORSPLAY
OTC & OTEE

10 weeks of occupational therapy in a clinic aimed at improving individual goals related to self-regulation, social communication, and play

OTC & OTEE

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Score ≥ 15 on the Social Communication Questionnaire
  • Diagnosed with autism by a community provider
  • Meet clinical cut-offs for autism on the ADOS or ADOS-2
  • Can follow 1-step directions
  • Score \>10 on ABC-C irritability subscale
  • Meet symptom criterion score of CASI-5 for mood, anxiety, or ADHD diagnosis
  • Meet PATH Intl medical and behavioral standards, and can ride a horse for 10 minutes while following safety rules.

You may not qualify if:

  • Participated in equine-assisted activities or therapies for 5 or more hours in the last 6 months
  • Weigh more than 200 pounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple Grandin Equine Center Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Related Links

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The occupational therapist that rates goal attainment will be blinded to treatment condition.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will receive 10 weeks of occupational therapy in a clinic, followed by occupational therapy in an equine environment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 22, 2020

Study Start

January 20, 2020

Primary Completion

November 9, 2021

Study Completion

November 9, 2021

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations