NCT04481334

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

4.8 years

First QC Date

July 10, 2020

Last Update Submit

March 28, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    20 minutes

  • 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.

    30 minutes

  • Parent Interview

    1. What do you view to be the benefits of the collaborative occupational therapy Interactive Vaulting program for your child? 2. Can you describe any changes in emotions or behaviors in your child during or after participating in the program? 3. Can you describe any relationships that have developed or changed during or after participating in the program? 4. What challenges did you or your child face related to participating in the vaulting program? 5. Would you recommend this program to someone else? Why or why not? 6. Do you plan on having your child participate in future sessions?

    30 minutes

  • 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.

    30 minutes

Study Arms (1)

One group

EXPERIMENTAL

One group pre-test, post-test design

Other: Collaborative occupational therapy interactive vaulting group

Interventions

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.

One group

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moonbeams and Miracles Therapeutic Horsemanship Center

Greenville, North Carolina, 27834, United States

RECRUITING

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Heather Panczykowski, DHSc, OTR/L

    East Carolina University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Panczykowski, DHSc, OTR/L

CONTACT

Denise Donica, DHSc, OTR/L

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 22, 2020

Study Start

August 15, 2019

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations