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Study: Effects of a Collaborative Occupational Therapy Interactive Vaulting

Primary Purpose

Executive Function, Social Interaction, Disability, Developmental

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative occupational therapy interactive vaulting group
Sponsored by
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Executive Function

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Moonbeams and Miracles Therapeutic Horsemanship CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One group

Arm Description

One group pre-test, post-test design

Outcomes

Primary Outcome Measures

Brief Rating Inventory of Executive Function-2
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.
Social Profile
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.
Parent Interview
What do you view to be the benefits of the collaborative occupational therapy Interactive Vaulting program for your child? Can you describe any changes in emotions or behaviors in your child during or after participating in the program? Can you describe any relationships that have developed or changed during or after participating in the program? What challenges did you or your child face related to participating in the vaulting program? Would you recommend this program to someone else? Why or why not? Do you plan on having your child participate in future sessions?
Weekly field notes using a-priori codes
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.

Secondary Outcome Measures

Full Information

First Posted
July 10, 2020
Last Updated
March 28, 2023
Sponsor
East Carolina University
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1. Study Identification

Unique Protocol Identification Number
NCT04481334
Brief Title
Study: Effects of a Collaborative Occupational Therapy Interactive Vaulting
Official Title
Study: Effects of a Collaborative Occupational Therapy Interactive Vaulting Program on Executive Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
East Carolina University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Occupational therapy services will be integrated into an interactive vaulting program which is an equine assisted activity. Children with disabilities ages 5-17 will participate. The objectives of this study are to determine the influence of a collaborative occupational therapy interactive vaulting program on the executive function and social participation in children with disabilities.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Executive Function, Social Interaction, Disability, Developmental

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The proposed mixed methods research follows a convergent design. The qualitative line of inquiry is embedded into the quantitative inquiry, using a one group pretest-posttest design. There is no control group, since there are no participants in the Interactive Vaulting group without disabilities.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One group
Arm Type
Experimental
Arm Description
One group pre-test, post-test design
Intervention Type
Other
Intervention Name(s)
Collaborative occupational therapy interactive vaulting group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Rating Inventory of Executive Function-2
Description
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.
Time Frame
20 minutes
Title
Social Profile
Description
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.
Time Frame
30 minutes
Title
Parent Interview
Description
What do you view to be the benefits of the collaborative occupational therapy Interactive Vaulting program for your child? Can you describe any changes in emotions or behaviors in your child during or after participating in the program? Can you describe any relationships that have developed or changed during or after participating in the program? What challenges did you or your child face related to participating in the vaulting program? Would you recommend this program to someone else? Why or why not? Do you plan on having your child participate in future sessions?
Time Frame
30 minutes
Title
Weekly field notes using a-priori codes
Description
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.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Panczykowski, DHSc, OTR/L
Phone
252 744 6194
Email
panczykowskih17@ecu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Donica, DHSc, OTR/L
Phone
2527446198
Email
donicad@ecu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Panczykowski, DHSc, OTR/L
Organizational Affiliation
East Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moonbeams and Miracles Therapeutic Horsemanship Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherri Moore, AS
Phone
252-414-7815
Email
sherrimoore119@gmail.com
First Name & Middle Initial & Last Name & Degree
Ashlyn Batten, MA
Phone
919 454 3092

12. IPD Sharing Statement

Plan to Share IPD
No

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Study: Effects of a Collaborative Occupational Therapy Interactive Vaulting

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