- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05698290
HELP Pain Training Program
April 18, 2024 updated by: Natoshia Cunningham, Michigan State University
Engaging School Providers to Manage Student Pain in Michigan Schools
The aim of this project is to develop and test the Helping Educators Learn Pediatric Pain Assessment & Intervention Needs (HELP Pain) program.
HELP Pain provides training for school providers (e.g., school nurses, mental health professionals) on strategies to assess and manage pain-related concerns in school children.
Participants will learn cognitive behavioral therapy techniques to help school children manage pain, and report on their use of strategies, and child's progress throughout the school year.
Follow-up data will be collected in year 2.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Chronic pain is common among school children, and impacts social, emotional and academic functioning.
School providers are often tasked with addressing student pain, but may have limited training in evidence-based pain management strategies.
Thus, the PI developed a training program, HELP Pain, to train school providers, such as school nurses and mental health professionals, in cognitive behavioral therapy strategies for addressing student pain.
In this study, the feasibility and acceptability of the training program will be evaluated.
Provider knowledge will be evaluated before and after receiving the HELP Pain training.
Further, the use of HELP Pain strategies with students and their associated disability and pain outcomes will be evaluated.
Results will help to tailor the HELP Pain training program for future use.
Study Type
Observational
Enrollment (Actual)
68
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
-
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Michigan State University
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Providers (nurses and mental health professionals) serving Michigan schools.
Description
Inclusion Criteria:
- engaged as a school provider in Michigan
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Health Department of Northwest Michigan
School providers (school nurses, mental health specialists) from the Health Department of Northwest Michigan.
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A training program to teach school providers nonpharmacologic (e.g., cognitive behavioral and mindfulness meditation) strategies to use with students with pain symptoms.
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Michigan Association of School Nurses
School providers (nurses) from the Michigan Association of School Nurses.
|
A training program to teach school providers nonpharmacologic (e.g., cognitive behavioral and mindfulness meditation) strategies to use with students with pain symptoms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility - Qualitative report
Time Frame: 9 months
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Implementation success of the program measured by a semi-structured qualitative interview method which addresses feasibility.
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9 months
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Acceptability - Qualitative report
Time Frame: 9 months
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Implementation success of the program measured by a semi-structured qualitative interview method which addresses acceptability.
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9 months
|
Appropriateness - Qualitative report
Time Frame: 9 months
|
Implementation success of the program measured by a semi-structured qualitative interview method which addresses appropriateness.
|
9 months
|
Implementation Success - Quantitative report
Time Frame: 9 months
|
Twelve psychometrically validated items to assess program implementation success, will be administered after training.
Providers will rate items with responses using a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5).
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9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge
Time Frame: 9 months
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Knowledge quiz scores before and after training, 0-20, where 20 indicates higher knowledge.
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9 months
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Fidelity
Time Frame: 9 months, 2 years
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Self-reported use of HELP Pain strategies with students via online survey.
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9 months, 2 years
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Self-report Knowledge
Time Frame: 9 months
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Self-reported agreeableness using a 5-point Likert scale from strongly disagree (1) to strongly agree (5) to 3 statements indicating knowledge from the program.
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9 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Functional Disability Inventory (FDI)
Time Frame: 9 months, 2 years
|
Administration of the FDI to students is optional.
The FDI is used to assess impairment due to pain over the past several days, and uses a Likert scale (0-4) to result in a score 0-60, where 60 implies decreased functioning.
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9 months, 2 years
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Child Pain Ratings - Numerical Scale
Time Frame: 9 months, 2 years
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Administration of the child pain ratings to students is optional.
Highest, lowest, average and current pain over the past week are reported by a child to the provider using a numerical scale.
The numerical scale is 0-10, with 10 indicating worse pain.
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9 months, 2 years
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Child Pain Ratings - Faces Scale
Time Frame: 9 months, 2 years
|
Administration of the child pain ratings to students is optional.
Highest, lowest, average and current pain over the past week are reported by a child to the provider using a faces scale.
The faces scale contains 6 faces with scores of 0, 2, 4, 6, 8, or 10 respectively from left to right, where the rightmost face or score of 10 indicates worse pain.
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9 months, 2 years
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Child School Attendance
Time Frame: 9 months, 2 years
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Reporting of a child's school attendance is optional.
School attendance, late arrivals, and early dismissal in one month (due to pain or other reasons), and school nurse visits for pain or other reasons (scheduled and unscheduled) as reported by the school provider specific to a child.
|
9 months, 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Natoshia R Cunningham, Ph.D., Michigan State University
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)
August 25, 2022
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
November 29, 2022
First Submitted That Met QC Criteria
January 13, 2023
First Posted (Actual)
January 26, 2023
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00007400
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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