Health Equity and Rural Education (HERE!) Clinical Trial

NCT ID: NCT06460116

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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The HERE pilot study will consist of two phases to strengthen and finalize the HERE school-based community health worker (SB-CHW) intervention. The 6-month Phase I will provide broad stakeholder feedback on the proposed model and rationale, the SB-CHW intervention, the associated domains and measures, and the evaluation. The following 18-month Phase II will align with the school year and provide a feasibility test of the training, intervention, data collection, and analyses.

Conditions

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Behavioral Symptoms Community Health Workers Social Determinants of Health Educational Problems

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a two phase feasibility pilot. Consistent with the community engaged approach, the first study phase is interviews with at least 30 stakeholders to enhance the school-based community health worker (SB-CHW) intervention and the enhanced usual care (EUC) arms. The second study phase is a feasibility trial to assess the feasibility of the SB-CHW condition across 38 students and 38 parent/guardians and the EUC condition across 10 students and their 10 parents/guardians.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

School-Based Community Health Worker (SB-CHW) intervention

Intervention Type BEHAVIORAL

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.

Study Phase II: Enhanced Usual Care

Enhanced usual care (EUC) is the comparator in the Phase II feasibility trial.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care (EUC) Methods

Intervention Type BEHAVIORAL

The network of school-based health centers without school-based community health workers will receive reminders of the the existing online social services directory.

Interventions

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School-Based Community Health Worker (SB-CHW) intervention

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.

Intervention Type BEHAVIORAL

Enhanced Usual Care (EUC) Methods

The network of school-based health centers without school-based community health workers will receive reminders of the the existing online social services directory.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eve-Lynn Nelson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eve-Lynn Nelson, PhD

Role: CONTACT

(913) 588-6323

Kelsey Dean

Role: CONTACT

(816) 652-0065

Other Identifiers

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1R56NR021161-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00151155

Identifier Type: -

Identifier Source: org_study_id

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