NCT06587230 Teachers Leading the Front Lines - North Carolina (Tealeaf-NC)
| NCT ID | NCT06587230 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Child Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 312 participants |
| Start Date | 2024-10-08 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 312 participants in total. It began in 2024-10-08 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted child mental health care. Participants: \~300 estimated Procedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods, clustered evaluation of Tealeaf-NC's Reach, Adoption \& Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness \& Maintenance (Secondary Outcomes, clinically-based).
Eligibility Criteria
Inclusion Criteria: Schools: * Have been trained in either Tealeaf or RE-SEED in Summer 2024 or 2025 after being randomized programmatically * Be a school in the State of North Carolina * Have an eligible principal Principals: * \>18 years old * Employed at an enrolled school * Not suspected or convicted of child-related misconduct or maltreatment Teachers: * \>18 years old * Employed at an enrolled school * Primary teaching responsibility for a single academic class (for a minimum of 1 hour per day and a minimum of 4 days per week) in any grade level Kindergarten to Grade 8 * Not suspected or convicted of child-related misconduct or maltreatment Counselors: * \>18 years old * Employed at an enrolled school * Hold a school counselor position at an enrolled school for at least 10 hours per week * Not suspected or convicted of child-related misconduct or maltreatment Students: * Enrolled in Kindergarten-Grade 8 * Student of an enrolled teacher * Has a parent or guardian who can provide consent * Positive/Clinical-level score on the Strengths and Difficulties Questionnaire (SDQ) Guardians: * \>18 years old * Guardian of enrolled student Exclusion Criteria: * Exclusion criteria will be set as each participant does not meet the inclusion criteria as set for their group.
Contact & Investigator
Christina R Cruz, MD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06587230 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 99 Years, studying Child Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06587230 currently recruiting?
Yes, NCT06587230 is actively recruiting participants. Contact the research team at christina_cruz@med.unc.edu for enrollment information.
Where is the NCT06587230 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06587230 clinical trial?
NCT06587230 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Christina R Cruz, MD at University of North Carolina, Chapel Hill. The trial plans to enroll 312 participants.