Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04482088 |
| Other study ID # |
20-10140H |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2020 |
| Est. completion date |
November 9, 2021 |
Study information
| Verified date |
August 2022 |
| Source |
Colorado State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The purpose of this study is to assess the feasibility, acceptability, and preliminary
efficacy of occupational therapy in an equine environment (OTEE) for youth with autism. As a
feasibility study, this study aims to accomplish several key development tasks. Specifically,
this study aims to:
1. Create a safe, feasible, and manualized control group that controls for non-animal
critical elements of the OTEE intervention
2. Assess welfare of the therapy horses that are integrated into the OTEE intervention
3. Enhance the OTEE manual by increasing standardization, while still allowing for
individualization
Design. We will implement a longitudinal design, where caregivers will complete outcomes
measures at 1)pre-test, 2) after their child participates in 10 weeks of occupational therapy
in a clinic environment and 3) after 10 weeks of occupational therapy in an equine
environment.
Participants. Youth with ASD will be screened for inclusion in a 2-part process that includes
1) an online survey and 2) virtual screening visit using Microsoft Teams. After completing 10
weeks of occupational therapy in a clinic environment, youth will then participate in an
additional screening visit and re-evaluation for OTEE to ensure they a) are able to mount and
ride a horse (with assistance) for 10 minutes while following safety rules, and b) meet all
PATH Intl criteria for participation in equine-assisted services. Twenty youth with autism
and their caregivers will be enrolled in the study. Occupational therapists that deliver the
interventions and other stakeholders (i.e. program coordinators, etc.) will also be asked to
be research participants.
Occupational Therapy Evaluation. Each youth and caregiver will participate in an occupational
therapy evaluation at Temple Grandin Equine Center (or virtually, depending on COVID
guidelines in 2021) that include an occupational profile, semi-structured interview, social
skills checklist, and collaborative goal setting. Therapists and caregivers will jointly
determine three goals for each youth with autism in the domains of self-regulation, social
communication, or social play.
Occupational Therapy in a Clinic (Control Group). The occupational therapy in a clinic
environment will occur at Temple Grandin Equine Center on CSU's foothills campus. We will
recruit occupational therapists to deliver the intervention who a) are licensed and
registered occupational therapists, and b) have at least 1-year of experience providing
occupational therapy to youth with autism. Included therapists will receive 5 hours of
training before each 10-week intervention session, as well as participate in 1-hour case
conferences every other week throughout the 10 week intervention session.
Youth with autism will be paired into dyads based on social communication and self-regulation
abilities. Dyads will attend 10 weekly 60-minute sessions of occupational therapy that follow
a general structure: greeting, activities in a play room, parent debrief, and goodbyes.
Therapists will design intervention activities based on the following critical elements:
direct instruction of goal behavior; activities in the playroom that elicit the goal
behavior; positive reinforcement of goal behaviors; use of behavioral techniques to scaffold
goal performance.
Hearts and Horses Screening Visit and Re-evaluation. Each youth will attend an additional
screening visit for the second portion of the study, to ensure they can safely ride a horse
with assistance and meet all medical and behavioral standards set forth by PATH Intl for
participation in equine-assisted services. Caregivers will be asked to bring the Hearts and
Horse enrollment packet, that includes physician signature that the youth can ride a horse.
Then, youth will ride a horse for 15 minutes. Finally, caregivers and youth will participate
in re-evaluations with an occupational therapist, to update or set new goals for 10 weeks of
OTEE.
OTEE Intervention (Intervention group). The OTEE intervention will occur at Hearts and Horses
Therapeutic Riding Center. The occupational therapists who will deliver the intervention are
licensed and registered, have completed training by the American Hippotherapy Association,
are PATH Intl registered instructors, and have experience delivering occupational therapy in
an equine environment to youth with autism. Included therapists will receive 5 hours of
training before each 10-week intervention session, as well as participate in 1-hour case
conferences every other week throughout the 10-week intervention session.
Youth with autism will be paired into dyads based on social communication and self-regulation
abilities. Dyads will attend 10 weekly 60-minute sessions of OTEE. Sessions follow a general
structure: greetings, activities with horses, parent debrief, goodbyes. Therapists design
intervention activities based on these critical elements: a) incorporation of horses to
optimize attention and engagement (includes use of equine movement to facilitate optimal
arousal) b) direct instruction of goal behavior, c) activities with horses that elicit the
goal behavior, d) positive reinforcement of goal behaviors, and e) use of behavioral
techniques to scaffold goal performance.
Equine Welfare. OTEE sessions will be videotaped. Noldus software will be used to analyze
equine behaviors using an applied ethogram, a behavioral scoring system in horses
incorporated in equine-assisted services that determines the presence or absence of stress.
Fidelity. Dr. Peters will rate the fidelity of 25% of intervention and control sessions.
Therapists will also provide self-ratings of fidelity for 20% of intervention and control
sessions.
Outcome Measures. All youth/caregiver outcome measures will be collected three times: once
before occupational therapy in a clinic environment, once before OTEE, and once after OTEE.
Caregivers will be asked to complete online surveys that include the following assessments:
Aberrant Behavior Checklist- Community (ABC-C) irritability and hyperactivity sub-scales,
Social Responsiveness Scale Second Edition (SRS-2), Pediatric Evaluation of Disability
Inventory Computer Adaptive Test for Autism Spectrum Disorders (PEDICAT-ASD), Emotional
Dysregulation Inventory (EDI), and World Health Organization Quality of Life- Brief
(WHOQOL-Brief). After each 10-week session, an occupational therapist blinded to treatment
condition will call each caregiver and conduct a semi-structured interview in order to rate
the child's performance on occupational performance goals using goal attainment scaling
methods.
Therapists will be asked to fill out feedback forms every other week during case conferences,
to gather immediate feedback on intervention delivery. After the evaluations/re-evaluations,
therapists will be asked to complete a short survey about the feasibility and acceptability
of the evaluations. At the conclusion of each 10-week session, therapists and other
stakeholders (i.e. program coordinator, etc.) will be asked to complete short surveys about
intervention acceptability, as well as attend a 1-hour audiotaped focus group to gather
feedback on the intervention manual.
Data Analysis. To assess feasibility and acceptability, we will calculate rates of
attendance, attrition, fidelity, assessment completion, safety events, and satisfaction. We
will conduct content analysis of focus group and feedback form data to inform intervention
and control manual revisions. Preliminary efficacy will be assessed using appropriate
parametric or non-parametric statistics.
