- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04481334
Study: Effects of a Collaborative Occupational Therapy Interactive Vaulting
Study: Effects of a Collaborative Occupational Therapy Interactive Vaulting Program on Executive Function
Study Overview
Status
Intervention / Treatment
Detailed Description
Investment by researchers has been made, however, little research exists that systematically evaluates the effectiveness of occupational therapy (OT) interventions in equine assisted activities, and none have included interactive vaulting. Research that has been conducted has supported the use of equines in OT treatment sessions (hippotherapy) in increasing length of time engaged in activities, compared to conventional therapy as well as improvements in postural sway, adaptive behaviors, and participation. In addition, it has been found that children with visual impairments who participated in a 6-week EAT program demonstrated clinically significant changes in occupational performance and qualitative themes of peer interaction, taking on challenges and overall satisfaction with the program.
The gaps in research warrant investigation into the efficacy of this intervention in the development of executive functioning and social skills in children with disabilities. Further research needs to be conducted to determine the effectiveness of occupational therapy in this context. Occupational therapy interventions will be integrated into the existing program. Group interventions will target the emotional awareness and regulation, social skills, and use cognitive strategies to improve social interactions with peers and adults.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Greenville, North Carolina, United States, 27834
- Recruiting
- Moonbeams and Miracles Therapeutic Horsemanship Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
Children must:
- have a documented developmental disability
- be eligible only to participate in equine assisted activities.
- be ambulatory with or without an assistive device
- be able to follow 2-3 step directions
- not be aggressive toward animals, peers, or staff
Exclusion criteria:
Children who:
- do not have a documented developmental disability
- are ONLY eligible for equine assisted therapy because of significant physical and/ or medical limitations (i.e.: occupational, physical, or speech therapy).
- are non-ambulatory
- are unable to follow 2-3 step directions
- are aggressive towards animals, peers, or staff
- does not have a developmental disorder (i.e.: has only mental health disorder)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: One group
One group pre-test, post-test design
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Children will participate in a weekly 60 minute group that focuses on the devilment of social skills by incorporating activities that require team work.
Part of the intervention will incorporate the equine to better understand non-verbal body language.
It should be noted that each child will have two agreed upon goals developed that are agreed upon by the child and the parent and will be of emphasis during each group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Rating Inventory of Executive Function-2
Time Frame: 20 minutes
|
Parent/ guardian and Teacher forms which have 63 items that measure the following domains of executive functioning: Inhibit, Self-Monitor, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task-Monitor, and Organization of Materials.
The individual items are categorized under one of three behavioral indices: Behavioral, Cognitive, and Emotional.
There is also an overall Global Executive Composite.
Poor executive functioning has been found to adversely effect the development of social skills.The Parent/ guardian and Teacher forms will be used in this study to gain the perspective of people who know the child at home, but also someone who knows them in a community setting without parent/ guardian's present.
This assessment will be completed prior to the first session and following the last session.
The BRIEF-2 has high internal consistency and test-re-test reliability.
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20 minutes
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Social Profile
Time Frame: 30 minutes
|
The Social Profile is an observational assessment that evaluates behavioral interactions in activity and cooperation of groups.
This assessment can allow the evaluator to assess one child's interaction and cooperation, or abilities of the entire group.
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30 minutes
|
Parent Interview
Time Frame: 30 minutes
|
|
30 minutes
|
Weekly field notes using a-priori codes
Time Frame: 30 minutes
|
Fieldnotes will be recorded by each researcher.
a Open coding will be initiated and a codebook will be developed, as sessions progress, to identify executive function and participation behaviors during the activities noted across children.
Behaviors will be tracked for frequency each session, and field notes will be kept regarding group activity and situational information when the behavior(s) occurred.
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30 minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMCIRB 18-001488
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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