HELP Pain Training Program

Pain Clinical Trial

Official title:

Engaging School Providers to Manage Student Pain in Michigan Schools

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05698290
• Other study ID #: STUDY00007400
• Status: Active, not recruiting
• Start date: August 25, 2022
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• engaged as a school provider in Michigan

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• HELP Pain Training Program
A training program to teach school providers nonpharmacologic (e.g., cognitive behavioral and mindfulness meditation) strategies to use with students with pain symptoms.

Locations

Country	Name	City	State
United States	Michigan State University	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child Functional Disability Inventory (FDI)	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
Other	Child Pain Ratings - Numerical Scale	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
Other	Child Pain Ratings - Faces Scale	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
Other	Child School Attendance	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
Primary	Feasibility - Qualitative report	Implementation success of the program measured by a semi-structured qualitative interview method which addresses feasibility.	9 months
Primary	Acceptability - Qualitative report	Implementation success of the program measured by a semi-structured qualitative interview method which addresses acceptability.	9 months
Primary	Appropriateness - Qualitative report	Implementation success of the program measured by a semi-structured qualitative interview method which addresses appropriateness.	9 months
Primary	Implementation Success - Quantitative report	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	Knowledge	Knowledge quiz scores before and after training, 0-20, where 20 indicates higher knowledge.	9 months
Secondary	Fidelity	Self-reported use of HELP Pain strategies with students via online survey.	9 months, 2 years
Secondary	Self-report Knowledge	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