- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04891328
Experience With a Pediatric Summer Intensive Therapy Program
March 24, 2022 updated by: Jamie Hall, University of Missouri-Columbia
The Experience of Participating in a Pediatric Summer Intensive Therapy Program--A Mixed Methods Study
The purpose of this study is to explore the lived experiences of children with neurodevelopmental diagnoses and their caregivers with an intensive model of therapy.
Children will receive usual care during the summer intensive program and the investigators will access medical records to assess effectiveness.
Children and caregivers will also be asked to participate in semi-structured interviews upon the completion of the episode of care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to explore the lived experiences of children with neurodevelopmental diagnoses and their caregivers with an intensive model of therapy.
Research questions include: 1.) What are the perceptions of children and caregivers about intensive therapy after participating in multiple intensive therapy episodes over time?
2.) Why do caregivers choose to continue with an intensive model of therapy periodically for their child with neurodevelopmental diagnoses?
3.) What were the outcomes for children with neurodevelopmental disabilities participating in an episode of intensive therapy?
Children will receive usual care during the summer intensive program and the investigators will access medical records to assess effectiveness.
Children and caregivers will also be asked to participate in semi-structured interviews upon the completion of the episode of care.
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65211
- University of Missouri Healthcare Children's Therapy Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children 4-15 years old with neurodevelopmental diagnoses and scheduled for an intensive therapy program over the summer.
Description
Inclusion Criteria:
- Children receiving therapy through the Children's Therapy Center's Tiger Intensive Program and their caregivers from May 24 to August 13 2021.
Exclusion Criteria:
- n/a
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Semi-structured interviews
Time Frame: at discharge assessed up to 10 days
|
Upon completion of the program, children and caregivers will participate in an interview about their experience
|
at discharge assessed up to 10 days
|
|
Canadian Occupational Performance Measure
Time Frame: measured at discharge 4 weeks after enrollment
|
Individualized client-centered performance measure
|
measured at discharge 4 weeks after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Lower extremity passive range of motion
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Measured at ankle, knee, and hip with goniometer
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in Thomas Test
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Hip flexor length test
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in popliteal angle
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Hamstring length test
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in Gastrocnemius muscle length
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Measured with goniometer
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in Kids Bestest
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Balance measure for pediatric patients
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in m-CTSIB
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Balance measure
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in Early Clinical Assessment of Balance
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Balance measure
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in Segmental Assessment of Trunk Control (SATCO)
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Measurement of trunk control
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in Edinburgh Visual Gait Scale
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Observational Gait measure
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in Timed Up and Down Stairs
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Measure of stair performance
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in Timed on and off the floor
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Measure of transition from floor to standing
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in 6 minute walk test
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Measure of walking performance
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in Peds QL
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Pediatric quality of life measure
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in GOAL
Time Frame: Measured at day 1 and discharge 4 weeks later
|
patient reported measure of function mobility
|
Measured at day 1 and discharge 4 weeks later
|
|
Change in Pediatric Evaluation of Disability Inventory
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Measure of amount of disability
|
Measured at day 1 and discharge 4 weeks later
|
|
Pediatric Balance Scale
Time Frame: Measured at day 1 and discharge 4 weeks later
|
Measure of balance
|
Measured at day 1 and discharge 4 weeks later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 24, 2021
Primary Completion (Actual)
September 1, 2021
Study Completion (Actual)
October 1, 2021
Study Registration Dates
First Submitted
April 29, 2021
First Submitted That Met QC Criteria
May 12, 2021
First Posted (Actual)
May 18, 2021
Study Record Updates
Last Update Posted (Actual)
March 28, 2022
Last Update Submitted That Met QC Criteria
March 24, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2058022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.