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

    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Michigan State University

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.
A training program to teach school providers nonpharmacologic (e.g., cognitive behavioral and mindfulness meditation) strategies to use with students with pain symptoms.
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
Implementation success of the program measured by a semi-structured qualitative interview method which addresses feasibility.
9 months
Acceptability - Qualitative report
Time Frame: 9 months
Implementation success of the program measured by a semi-structured qualitative interview method which addresses acceptability.
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).
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge
Time Frame: 9 months
Knowledge quiz scores before and after training, 0-20, where 20 indicates higher knowledge.
9 months
Fidelity
Time Frame: 9 months, 2 years
Self-reported use of HELP Pain strategies with students via online survey.
9 months, 2 years
Self-report Knowledge
Time Frame: 9 months
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.
9 months

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.
9 months, 2 years
Child Pain Ratings - Numerical 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 numerical scale. The numerical scale is 0-10, with 10 indicating worse pain.
9 months, 2 years
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.
9 months, 2 years
Child School Attendance
Time Frame: 9 months, 2 years
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.

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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