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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- Create a safe, feasible, and manualized control group that controls for non-animal critical elements of the OTEE intervention
- Assess welfare of the therapy horses that are integrated into the OTEE intervention
- 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.
- Conditions
- Autism Spectrum Disorder
- 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 group | Role | What they receive |
|---|---|---|
| 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 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.
Change in Goal Performance using Goal Attainment Scaling
Performance on individualized occupational performance goals
Measured: 10 weeks
Secondary outcomes (5)
Change in Aberrant Behavior Checklist- Community
Irritability and hyperactivity
Measured: 10 weeks
Change in Social Responsiveness Scale, Second Edition
Social Functioning
Measured: 10 weeks
Change in Pediatric Disability Inventory Computer Adaptive Test for Autism Spectrum Disorders
Adaptive behaviors
Measured: 10 weeks
Change in World Health Organization Quality of Life- BREF
Quality of Life
Measured: 10 weeks
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.
- First posted22 Jul 2020
- Study start20 Jan 2020
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Hearts and Horses Therapeutic Riding Center
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting an Enhanced Protocol of Occupational Therapy in an Equine Environment for Youth With Autism
- ClinicalTrials.gov ID
- NCT04482088
- Acronym / sponsor ID
- 20-10140H
- Conditions
- Autism Spectrum Disorder
- Keywords
- occupational therapy, equine-assisted services, hippotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Hearts and Horses Therapeutic Riding Center
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 22 Jul 2020 (actual)
- 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.
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.
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:
- Create a safe, feasible, and manualized control group that controls for non-animal critical elements of the OTEE intervention
- Assess welfare of the therapy horses that are integrated into the OTEE intervention
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive 10 weeks of occupational therapy in a clinic, followed by occupational therapy in an equine environment
| Arm | Type | Receives |
|---|---|---|
| OTC & OTEE | Experimental | Behavioral: Occupational Therapy in an Equine Environment, Behavioral: Occupational Therapy in a Clinic (OTC)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 |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Participated in equine-assisted activities or therapies for 5 or more hours in the last 6 months
- Weigh more than 200 pounds
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 |
|---|---|---|
| Occupational Therapy in an Equine EnvironmentAlso: OTEE-HORSPLAY10 weeks of occupational therapy in an equine environment aimed at improving individual goals related to self-regulation, social communication, and play | Behavioural | OTC & OTEE |
| Occupational Therapy in a Clinic (OTC)10 weeks of occupational therapy in a clinic aimed at improving individual goals related to self-regulation, social communication, and play | Behavioural | OTC & OTEE |
Primary outcome
Change in Goal Performance using Goal Attainment Scaling
Time frame: 10 weeks
Performance on individualized occupational performance goals
5 secondary outcomes
Change in Aberrant Behavior Checklist- Community
Time frame: 10 weeks
Change in Social Responsiveness Scale, Second Edition
Time frame: 10 weeks
Change in Pediatric Disability Inventory Computer Adaptive Test for Autism Spectrum Disorders
Time frame: 10 weeks
Change in World Health Organization Quality of Life- BREF
Time frame: 10 weeks
Change in Emotional Dysregulation Inventory
Time frame: 10 weeks
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 22 Aug 2022.
- Temple Grandin Equine CenterLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.