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Autism Spectrum DisorderNCT04482088

Piloting an Enhanced Protocol of Occupational Therapy in an Equine Environment for Youth With Autism

A study testing Occupational Therapy in an Equine Environment and Occupational Therapy in a Clinic (OTC) in people with Autism Spectrum Disorder, run by Colorado State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 6 to 13 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Occupational Therapy in an Equine Environment and Occupational Therapy in a Clinic (OTC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
20 Jan 2020to 9 Nov 2021
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 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Temple Grandin Equine Center Colorado State University

    Fort Collins, Colorado, 80523

Other trials in United States

About this study

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.

Read the detailed 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.

Being tested
Occupational Therapy in an Equine Environment, Occupational Therapy in a Clinic (OTC)
Keywords
occupational therapy, equine-assisted services, hippotherapy
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Occupational Therapy in an Equine EnvironmentBehavioural

    Also called OTEE-HORSPLAY

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

  • Occupational Therapy in a Clinic (OTC)Behavioural

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

Study groups in NCT04482088
Study groupRoleWhat they receive
OTC & OTEEExperimentalEvery participant will receive 10 weeks of occupational therapy in a clinic environment (OTC) followed by 10 weeks of occupational therapy in an equine environment
Receives: Behavioral: Occupational Therapy in an Equine Environment; Behavioral: Occupational Therapy in a Clinic (OTC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Goal Performance using Goal Attainment Scaling

    Performance on individualized occupational performance goals

    Measured: 10 weeks

Secondary outcomes (5)
  1. Change in Aberrant Behavior Checklist- Community

    Irritability and hyperactivity

    Measured: 10 weeks

  2. Change in Social Responsiveness Scale, Second Edition

    Social Functioning

    Measured: 10 weeks

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

    Adaptive behaviors

    Measured: 10 weeks

  4. Change in World Health Organization Quality of Life- BREF

    Quality of Life

    Measured: 10 weeks

  5. Change in Emotional Dysregulation Inventory

    Emotional Regulation

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2020
  2. Study start20 Jan 2020
  3. Primary completion9 Nov 2021
  4. Study completion9 Nov 2021

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive 10 weeks of occupational therapy in a clinic, followed by occupational therapy in an equine environment
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04482088
Sponsor's protocol ID
20-10140H
Status last verified
Aug 2022
First submitted
16 Jul 2020
Last updated
22 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Occupational Therapy in an Equine Environment and Occupational Therapy in a Clinic (OTC) in people with Autism Spectrum Disorder, run by Colorado State University at 1 site in United States.

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 7 inclusion and 2 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 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Goal Performance using Goal Attainment Scaling (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 22 Aug 2022.

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