Clinical trial NCT06460116: Health Equity and Rural Education (HERE!) Clinical Trial
Official title: Health Equity and Rural Education (HERE!) Clinical Trial: A Healthcare-Community Partnership Leveraging School-Based Community Health Workers to Improve Student Attendance
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Behavioral Symptoms
Community Health Workers
Social Determinants of Health
Educational Problems
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: National Institutes of Health (NIH)
First posted: 2024-06-14
Enrollment: 126
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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 in grades 6-12 (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.

Primary outcomes:
measure: School Based Health Services Utilization
timeFrame: At study completion (an average of 10 months/1 school year)
measure: School Attendance
timeFrame: At study completion (an average of 10 months/1 school year)
Secondary outcomes:
measure: Parent & Child Self-Sufficiency and Needs
timeFrame: At enrollment, at study completion (an average of 10 months/1 school year)
measure: Child and Adolescent Needs and Strengths
timeFrame: At enrollment, at study completion (an average of 10 months/1 school year)
measure: Family Engagement
timeFrame: At enrollment, at study completion (an average of 10 months/1 school year)
measure: School-Based Community Health Worker Interactions
timeFrame: At study completion (an average of 10 months/1 school year)
measure: Process for Enhanced Usual Care
timeFrame: At enrollment, at study completion (an average of 10 months/1 school year)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Eve-Lynn Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: