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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06460116
Other study ID # STUDY00151155
Secondary ID 1R56NR021161-01
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 31, 2025

Study information

Verified date June 2024
Source University of Kansas Medical Center
Contact Eve-Lynn Nelson, PhD
Phone (913) 588-6323
Email enelson2@kumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 131
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
School-Based Community Health Worker (SB-CHW) intervention
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) Methods
The network of school-based health centers without school-based community health workers will receive reminders of the the existing online social services directory.

Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (3)

Lead Sponsor Collaborator
University of Kansas Medical Center National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 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. At enrollment, at study completion (an average of 10 months/1 school year)
Secondary 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). At enrollment, at study completion (an average of 10 months/1 school year)
Secondary 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). At enrollment, at study completion (an average of 10 months/1 school year)
Secondary School-Based Community Health Worker Interactions Number of CHW interactions with the student, parent/guardian, and/or both At study completion (an average of 10 months/1 school year)
Secondary Process for Enhanced Usual Care Use of resources from the online social services directory (yes/no) At enrollment, at study completion (an average of 10 months/1 school year)
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