NCT06587230 · University of North Carolina, Chapel Hill
Teachers Leading the Front Lines - North Carolina (Tealeaf-NC)
(Tealeaf-NC)
What this study is about
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.
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Chapel Hill, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 27, 2025 · Source of record for eligibility and locations