Clinical trial NCT04481334: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Executive Function
Social Interaction
Disability, Developmental
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Brief Rating Inventory of Executive Function-2
timeFrame: 20 minutes
measure: Social Profile
timeFrame: 30 minutes
measure: Parent Interview
timeFrame: 30 minutes
measure: Weekly field notes using a-priori codes
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Moonbeams and Miracles Therapeutic Horsemanship Center
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Heather Panczykowski, DHSc, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: