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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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