Health Equity and Rural Education (HERE!) Clinical Trial

NCT06460116 | Recruiting

• 2 other identifiers: STUDY001511551R56NR021161-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Behavioral Symptoms; Community Health Workers; Social Determinants of Health; Educational Problems

Outcome Measures

Primary Outcomes (2)

• School Based Health Services Utilization

  The number of visits to School Based Health Centers (SBHC)

  At study completion (an average of 10 months/1 school year)

• School Attendance

  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)

Secondary Outcomes (5)

• Parent & Child Self-Sufficiency and Needs

  At enrollment, at study completion (an average of 10 months/1 school year)

• Child and Adolescent Needs and Strengths

  At enrollment, at study completion (an average of 10 months/1 school year)

• Family Engagement

  At enrollment, at study completion (an average of 10 months/1 school year)

• School-Based Community Health Worker Interactions

  At study completion (an average of 10 months/1 school year)

• Process for Enhanced Usual Care

  At enrollment, at study completion (an average of 10 months/1 school year)

Study Arms (3)

Study Phase I: Stakeholder Interviews

NO INTERVENTION

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.

Study Phase II: School-based Community Health Worker Intervention

EXPERIMENTAL

The School-Based Community Health Worker (SB-CHW) intervention is the active intervention in the Phase II feasibility trial.

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

Study Phase II: Enhanced Usual Care

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care (EUC) Methods

Interventions

Enhanced Usual Care (EUC) Methods 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.

Study Phase II: Enhanced Usual Care

School-Based Community Health Worker (SB-CHW) intervention 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: School-based Community Health Worker Intervention

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Parents/guardians or youth with profound intellectual/cognitive disability will be excluded.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of Nursing Research (NINR): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Behavioral Symptoms

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Eve-Lynn Nelson, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eve-Lynn Nelson, PhD

CONTACT

(913) 588-6323; enelson2@kumc.edu

Kelsey Dean

CONTACT

(816) 652-0065; kdean@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: June 14, 2024
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Final submission and release of the study data will occur approximately 6 months following the end of Phase 1 and Phase 2, respectively, and within the award period. Study data deposited in DSDR will be available to the research community in perpetuity. Datasets underlying methodological publications will be shared at or prior to initial publication date.
• Access Criteria: All deidentified study data that are not designated as restricted use will be made available as public use data to the research community via DSDR, with users of the public use data compliant with all Terms of Use. Data that are determined to be potentially identifying through indirect or deductive disclosure are provided under restricted data contract to users who demonstrate a valid research need and meet conditions of use. Access to restricted study data is available via a virtual data enclave system at DSDR/ICPSR.

Locations

US (1)