NCT05698290

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Aug 2022Nov 2026

Study Start

First participant enrolled

August 25, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

November 29, 2022

Last Update Submit

April 8, 2026

Conditions

Keywords

PainCognitive Behavioral TherapySchool Providers

Outcome Measures

Primary Outcomes (4)

  • Feasibility - Qualitative report

    Implementation success of the program measured by a semi-structured qualitative interview method which addresses feasibility.

    9 months

  • Acceptability - Qualitative report

    Implementation success of the program measured by a semi-structured qualitative interview method which addresses acceptability.

    9 months

  • Appropriateness - Qualitative report

    Implementation success of the program measured by a semi-structured qualitative interview method which addresses appropriateness.

    9 months

  • 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 Outcomes (3)

  • Knowledge

    9 months

  • Fidelity

    9 months, 2 years

  • Self-report Knowledge

    9 months

Other Outcomes (4)

  • Child Functional Disability Inventory (FDI)

    9 months, 2 years

  • Child Pain Ratings - Numerical Scale

    9 months, 2 years

  • Child Pain Ratings - Faces Scale

    9 months, 2 years

  • +1 more other outcomes

Study Arms (2)

Health Department of Northwest Michigan

School providers (school nurses, mental health specialists) from the Health Department of Northwest Michigan.

Other: HELP Pain Training Program

Michigan Association of School Nurses

School providers (nurses) from the Michigan Association of School Nurses.

Other: HELP Pain Training Program

Interventions

A training program to teach school providers nonpharmacologic (e.g., cognitive behavioral and mindfulness meditation) strategies to use with students with pain symptoms.

Health Department of Northwest MichiganMichigan Association of School Nurses

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Providers (nurses and mental health professionals) serving Michigan schools.

You may qualify if:

  • engaged as a school provider in Michigan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Natoshia R Cunningham, Ph.D.

    Michigan State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 29, 2022

First Posted

January 26, 2023

Study Start

August 25, 2022

Primary Completion

July 1, 2024

Study Completion (Estimated)

November 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations