Executive FunctionNCT04481334
Study: Effects of a Collaborative Occupational Therapy Interactive Vaulting
A study testing Collaborative occupational therapy interactive vaulting group in people with Executive Function and Social Interaction, run by East Carolina University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Executive Function, Social Interaction, Disability, Developmental
- What is being tested?
- Collaborative occupational therapy interactive vaulting group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 31 May 2024
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Moonbeams and Miracles Therapeutic Horsemanship Center
Greenville, North Carolina, 27834
Sherri Moore, AS, 252-414-7815, sherrimoore119@gmail.com
Ashlyn Batten, MA, 919 454 3092
About this study
Official title: Study: Effects of a Collaborative Occupational Therapy Interactive Vaulting Program on Executive Function
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.
Read the 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.
- Being tested
- Collaborative occupational therapy interactive vaulting group
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative occupational therapy interactive vaulting groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| One group | Experimental | One group pre-test, post-test design Receives: Other: Collaborative occupational therapy interactive vaulting group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes
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?
Measured: 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.
Measured: 30 minutes
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 start15 Aug 2019
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive FunctionStudies 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
- 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)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Panczykowski, DHSc, OTR/L, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481334
- Sponsor's protocol ID
- UMCIRB 18-001488
- Status last verified
- Mar 2023
- First submitted
- 10 Jul 2020
- Last updated
- 29 Mar 2023
- 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 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study: Effects of a Collaborative Occupational Therapy Interactive Vaulting Program on Executive Function
- ClinicalTrials.gov ID
- NCT04481334
- Acronym / sponsor ID
- UMCIRB 18-001488
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| One group | Experimental | Other: Collaborative occupational therapy interactive vaulting groupOne group pre-test, post-test design |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Collaborative occupational therapy interactive vaulting groupChildren 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. | Other | One group |
Primary outcome
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.
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.
Parent Interview
Time frame: 30 minutes
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?
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- 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.
Heather Panczykowski, DHSc, OTR/L principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative occupational therapy interactive vaulting group in people with Executive Function and Social Interaction, run by East Carolina 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Panczykowski, DHSc, OTR/L (252 744 6194, panczykowskih17@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Rating Inventory of Executive Function-2 (time frame: 20 minutes). The study lists 4 primary outcomes in all. 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 29 Mar 2023.