- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06460116
Health Equity and Rural Education (HERE!) Clinical Trial (HERE)
Health Equity and Rural Education (HERE!) Clinical Trial: A Healthcare-Community Partnership Leveraging School-Based Community Health Workers to Improve Student Attendance
The goal of this community-engaged research is two-fold. The first goal is to gather stakeholder feedback to inform a school-based community health worker intervention with youth with poor school attendance and an enhanced usual care condition. The second goal is to evaluate the feasibility of implementing the school-based community health worker intervention and enhanced usual care approach within rural schools.
The main question it aims to answer is whether it is feasibile to recruit children with poor school attendance and their families to the intervention, to complete the trauma-informed intervention, and to complete the associated study measures of meeting social determinants of health/mental health needs, school-based health center utilization, and behavioral helath symptoms. At least 38 rural students in grades 6-12 with poor school attendance and their parents/guardians will meet with the school-based community health worker for support around social determinants of health needs that may be barriers to attendance. Researchers will also assess the feasibility of recruiting at least 10 rural students and their parents/guardians to complete the study measures in an enhanced usual care condition in which the school-based health center without a school-based community health worker is reminded of the availability of an online social services directory.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eve-Lynn Nelson, PhD
- Phone Number: (913) 588-6323
- Email: enelson2@kumc.edu
Study Contact Backup
- Name: Kelsey Dean
- Phone Number: (816) 652-0065
- Email: kdean@kumc.edu
Study Locations
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Kansas
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Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Phase I Stakeholder Interviews (nonintervention):
Inclusion Criteria:
- A member of the program's Community Advisory Board, including community health workers;
- Caregiver of a child ages 12-18 from the Southeast Kansas region; or
- Student at least 12 years in age.
Phase II Feasibility Pilot- SB-CHW Intervention and Enhanced Usual Care Conditions
Inclusion Criteria:
- Children ages 12-18 and their parents/guardians from the Southeast Kansas region
- Student with or at risk for chronic poor attendance (missing 10% or more of the days that school has been in session at any point in the school year)
Exclusion Criteria:
- Parents/guardians or youth with profound intellectual/cognitive disability will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Study Phase I: Stakeholder Interviews
Phase I interviews with stakeholders (Community Advisory Board members, CHWs, community members, students Grade 6-12, & parent stakeholders) will be completed to inform the school-based community health worker and the enhanced usual care conditions in the Phase 2 feasibility pilot.
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Experimental: Study Phase II: School-based Community Health Worker Intervention
The School-Based Community Health Worker (SB-CHW) intervention is the active intervention in the Phase II feasibility trial.
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The school-based community health worker will support students with chronic poor attendance and their parent/guardian for a minimum of two 30-minute encounters focused on addressing social determinants needs, understanding the range/student encounter varies greatly due to the intensity of the social need(s) (e.g., crisis/noncrisis) and the number of needs being jointly addressed.
The SB-CHW will build relationships across encounters and apply trauma-informed best practices.
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Active Comparator: Study Phase II: Enhanced Usual Care
Enhanced usual care (EUC) is the comparator in the Phase II feasibility trial.
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The network of school-based health centers without school-based community health workers will receive reminders of the the existing online social services directory.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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School Based Health Services Utilization
Time Frame: At study completion (an average of 10 months/1 school year)
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The number of visits to School Based Health Centers (SBHC)
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At study completion (an average of 10 months/1 school year)
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School Attendance
Time Frame: At study completion (an average of 10 months/1 school year)
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The number of school days in attendance, collected by ½ day increments 1(b) determination whether the student continues to meet the definition of chronic poor attendance (Yes/No) |
At study completion (an average of 10 months/1 school year)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent & Child Self-Sufficiency and Needs
Time Frame: At enrollment, at study completion (an average of 10 months/1 school year)
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Arizona Self-Sufficiency Matrix.
An 18-item self-report measure assessing needs on a 5-point Likert scale, including Housing, Employment, Income, Food, Childcare, Children's Education, Adult Education, Health Care Coverage, Life Skills, Family/Social Relations, Mobility, Community Involvement, Parenting Skills, Legal, Mental Health, Substance Abuse, Safety, and Disabilities.
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At enrollment, at study completion (an average of 10 months/1 school year)
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Child and Adolescent Needs and Strengths
Time Frame: At enrollment, at study completion (an average of 10 months/1 school year)
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Child and Adolescent Needs and Strengths (CANS) is a validated semi-structured interview that assesses children's exposure to potentially traumatic experiences & level of traumatic stress symptoms, as well as considering strengths (Kisiel & Fehrenbach, 2015).
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At enrollment, at study completion (an average of 10 months/1 school year)
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Family Engagement
Time Frame: At enrollment, at study completion (an average of 10 months/1 school year)
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The Family Engagement Survey -- Version 2 (FES), a validated measure of family and school engagement consisting of 20 items rated on a Likert-type scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
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At enrollment, at study completion (an average of 10 months/1 school year)
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School-Based Community Health Worker Interactions
Time Frame: At study completion (an average of 10 months/1 school year)
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Number of CHW interactions with the student, parent/guardian, and/or both
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At study completion (an average of 10 months/1 school year)
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Process for Enhanced Usual Care
Time Frame: At enrollment, at study completion (an average of 10 months/1 school year)
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Use of resources from the online social services directory (yes/no)
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At enrollment, at study completion (an average of 10 months/1 school year)
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Collaborators and Investigators
Investigators
- Principal Investigator: Eve-Lynn Nelson, PhD, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00151155
- 1R56NR021161-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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