An interventional study of School-Based Community Health Worker (SB-CHW) intervention and Enhanced Usual Care (EUC) Methods in Behavioral Symptoms, Community Health Workers and Social Determinants of Health, sponsored by University of Kansas Medical Center. Recruiting at 1 site in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
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.
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.
135 studies on the registry are indexed under Behavioral Symptoms; 18 are open to participants now.
This study's planned enrollment of 126 is above the median of 93 across 114 interventional studies indexed under Behavioral Symptoms.
Browse Behavioral Symptoms studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Phase I Stakeholder Interviews (nonintervention):
Inclusion Criteria:
Phase II Feasibility Pilot- SB-CHW Intervention and Enhanced Usual Care Conditions
Inclusion Criteria:
Exclusion Criteria:
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.
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
Enhanced usual care (EUC) is the comparator in the Phase II feasibility trial.
Behavioral: Enhanced Usual Care (EUC) Methods
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.
The network of school-based health centers without school-based community health workers will receive reminders of the the existing online social services directory.
School Based Health Services Utilization
The number of visits to School Based Health Centers (SBHC)
Time frame: 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)
Time frame: At study completion (an average of 10 months/1 school year)
Parent & Child Self-Sufficiency and Needs
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.
Time frame: At enrollment, at study completion (an average of 10 months/1 school year)
Child and Adolescent Needs and Strengths
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).
Time frame: At enrollment, at study completion (an average of 10 months/1 school year)
Family Engagement
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).
Time frame: At enrollment, at study completion (an average of 10 months/1 school year)
School-Based Community Health Worker Interactions
Number of CHW interactions with the student, parent/guardian, and/or both
Time frame: At study completion (an average of 10 months/1 school year)
Process for Enhanced Usual Care
Use of resources from the online social services directory (yes/no)
Time frame: At enrollment, at study completion (an average of 10 months/1 school year)
Plan to share: Yes — Public use and restricted access study data and associated documentation will be made available to the research community free of charge through the Data Sharing for Demographic Research (DSDR) data repository hosted at ICPSR. Datasets in DSDR will be findable and identifiable through a study digital object identifier (DOI) minted by ICPSR. Monitoring of and compliance with this Data Management and Sharing Plan will be the responsibility of the project's Principal Investigator and follow the data management and sharing plan compliance system through The Office of Sponsored Programs at the University of Kansas Medical Center that will be administering this award. The Office of Sponsored Programs will also look for the funder requirements and will include that information in the annual progress report.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Dec 2026, 7 months later.
Of 68 non-industry interventional studies with no phase under Behavioral Symptoms, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's planned 7 months is below that.
Counting every sponsor, half of 68 studies reached it within 27 months; a quarter within 16 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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