Community Health Workers for Learning Difficulties

(HERE Trial)

Overseen By Kelsey Dean

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Profound intellectual/cognitive disability

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

126 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Enhanced Usual Care (EUC) Methods, School-Based Community Health Worker (SB-CHW) intervention?

Research shows that community health workers (CHWs) can effectively support self-management of chronic conditions like type 2 diabetes and asthma, especially in underserved communities. CHWs have been successful in providing health education and care coordination, which suggests they could be beneficial in school settings for learning difficulties. ^{1 2 3 4 5}

Is the Community Health Worker intervention safe for humans?

The available research does not specifically address safety concerns for Community Health Worker interventions, but these programs are generally designed to provide health education and support, which suggests they are safe for human use. ^{2 5 6 7 8}

How is the School-Based Community Health Worker (SB-CHW) intervention different from other treatments for learning difficulties?

The School-Based Community Health Worker (SB-CHW) intervention is unique because it involves community health workers (CHWs) who are trusted community members providing health education and care directly within school settings. This approach is novel as it integrates health support into the educational environment, potentially filling gaps in health resources that schools often face, which is not a common feature of other treatments for learning difficulties. ^{5 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Eve-Lynn Nelson, PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

The HERE! Clinical Trial is for rural students in grades 6-12 who struggle with school attendance and their parents or guardians. Participants should be facing social challenges that affect schooling. The trial excludes those not fitting the age or grade criteria, living outside of rural areas, or unable to commit to the intervention's requirements.

Inclusion Criteria

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)

I am a student and at least 12 years old.

I am a parent/guardian of a child aged 12-18 in Southeast Kansas.

Exclusion Criteria

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

Timeline

Stakeholder Interviews

Phase I interviews with stakeholders to inform the school-based community health worker and enhanced usual care conditions

6 months

School-based Community Health Worker Intervention

Implementation of the School-Based Community Health Worker intervention to support students with poor school attendance

18 months

Enhanced Usual Care

Comparator phase where enhanced usual care is provided without a school-based community health worker

18 months

Follow-up

Participants are monitored for outcomes such as school attendance and health service utilization

10 months

Treatment Details

Interventions

• Enhanced Usual Care (EUC) Methods
• School-Based Community Health Worker (SB-CHW) intervention

Trial Overview This study tests a School-Based Community Health Worker (SB-CHW) intervention against Enhanced Usual Care (EUC). It aims to see if it's possible to recruit families for these programs, carry out a trauma-informed approach, and measure improvements in health needs, clinic use, and behavioral symptoms.

Participant Groups

Group I: Study Phase II: School-based Community Health Worker Intervention Experimental Treatment 1 Intervention

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

Group II: Study Phase II: Enhanced Usual Care Active Control 1 Intervention

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

Group III: Study Phase I: Stakeholder Interviews Active Control 1 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.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

A community health worker (CHW) intervention significantly improved long-term self-management of type 2 diabetes in patients facing social disadvantages, with 33% achieving self-care generativity after engaging with the program.

Patients who reached self-care generativity showed greater declines in hemoglobin A1c (HbA1c) levels over time, averaging 8.5% compared to 8.8% and 9.0% in other groups, and had lower rates of emergency department and hospital visits, indicating improved health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Workers as Trust Builders and Healers: A Cohort Study in Primary Care. Ferrer, RL., Schlenker, CG., Cruz, I., et al.[2022]

Community health worker (CHW) interventions, particularly those involving home visits and women's groups, can improve equitable access to maternal and newborn health services in low-income and middle-income countries, as shown in a review of 22 studies.

While some CHW interventions have successfully reduced health inequities, others have not, indicating that the effectiveness of these programs can vary based on the type of intervention and the support provided to CHWs in their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of community health worker interventions on socioeconomic inequities in maternal and newborn health in low-income and middle-income countries: a mixed-methods systematic review. Blanchard, AK., Prost, A., Houweling, TAJ.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Implementation Lessons From a Randomized Trial Integrating Community Asthma Education for Children. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A Real-World Community Health Worker Care Coordination Model for High-Risk Children. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Improving asthma-related health outcomes among low-income, multiethnic, school-aged children: results of a demonstration project that combined continuous quality improvement and community health worker strategies. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Community Health Workers as Trust Builders and Healers: A Cohort Study in Primary Care. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Community Health Workers in Schools: A Systematic Review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation protocol to assess maternal and child health outcomes using administrative data: a community health worker home visiting programme. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Community health workers and health equity in low- and middle-income countries: systematic review and recommendations for policy and practice. [2022]

8. England pubmed.ncbi.nlm.nih.gov

How equitable are community health worker programmes and which programme features influence equity of community health worker services? A systematic review. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Community health workers' perspectives on integrating into school settings to support student health. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Effects of community health worker interventions on socioeconomic inequities in maternal and newborn health in low-income and middle-income countries: a mixed-methods systematic review. [2022]