Behavioral SymptomsHERENCT06460116
Health Equity and Rural Education (HERE!) Clinical Trial
A study testing School-Based Community Health Worker (SB-CHW) intervention in people with Behavioral Symptoms and Community Health Workers, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavioral Symptoms, Community Health Workers, Social Determinants of Health
- What is being tested?
- School-Based Community Health Worker (SB-CHW) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Parents/guardians or youth with profound intellectual/cognitive disability will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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.
Read the 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.
- Conditions
- Behavioral Symptoms, Community Health Workers, Social Determinants of Health, Educational Problems
- Being tested
- School-Based Community Health Worker (SB-CHW) intervention, Enhanced Usual Care (EUC) Methods
- Medical subject headings
- Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-Based Community Health Worker (SB-CHW) interventionBehavioural
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.
Enhanced Usual Care (EUC) MethodsBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Usual Care (EUC) Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
School Based Health Services Utilization
The number of visits to School Based Health Centers (SBHC)
Measured: 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)
Measured: At study completion (an average of 10 months/1 school year)
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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)
Measured: At enrollment, at study completion (an average of 10 months/1 school year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start15 May 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral SymptomsStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Eve-Lynn Nelson, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460116
- Sponsor's protocol ID
- STUDY00151155
- Other IDs
- 1R56NR021161-01
- Acronym
- HERE
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Equity and Rural Education (HERE!) Clinical Trial: A Healthcare-Community Partnership Leveraging School-Based Community Health Workers to Improve Student Attendance
- ClinicalTrials.gov ID
- NCT06460116
- Acronym / sponsor ID
- HERE / STUDY00151155
- Conditions
- Behavioral Symptoms, Community Health Workers, Social Determinants of Health, Educational Problems
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Study start
- 15 May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: School-Based Community Health Worker (SB-CHW) interventionThe School-Based Community Health Worker (SB-CHW) intervention is the active intervention in the Phase II feasibility trial. |
| Study Phase II: Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual Care (EUC) MethodsEnhanced usual care (EUC) is the comparator in the Phase II feasibility trial. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Parents/guardians or youth with profound intellectual/cognitive disability will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School-Based Community Health Worker (SB-CHW) interventionThe 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. | Behavioural | Study Phase II: School-based Community Health Worker Intervention |
| Enhanced Usual Care (EUC) MethodsThe network of school-based health centers without school-based community health workers will receive reminders of the the existing online social services directory. | Behavioural | Study Phase II: Enhanced Usual Care |
Primary outcome
School Based Health Services Utilization
Time frame: At study completion (an average of 10 months/1 school year)
The number of visits to School Based Health Centers (SBHC)
School Attendance
Time frame: At study completion (an average of 10 months/1 school year)
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)
5 secondary outcomes
Parent & Child Self-Sufficiency and Needs
Time frame: At enrollment, at study completion (an average of 10 months/1 school year)
Child and Adolescent Needs and Strengths
Time frame: At enrollment, at study completion (an average of 10 months/1 school year)
Family Engagement
Time frame: At enrollment, at study completion (an average of 10 months/1 school year)
School-Based Community Health Worker Interactions
Time frame: At study completion (an average of 10 months/1 school year)
Process for Enhanced Usual Care
Time frame: At enrollment, at study completion (an average of 10 months/1 school year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eve-Lynn Nelson, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-Based Community Health Worker (SB-CHW) intervention in people with Behavioral Symptoms and Community Health Workers, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eve-Lynn Nelson, PhD ((913) 588-6323, enelson2@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School Based Health Services Utilization (time frame: At study completion (an average of 10 months/1 school year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.