Teachers Leading the Front Lines - North Carolina (Tealeaf-NC) (NCT06587230) | Clinical Trial Compass
RecruitingNot Applicable
Teachers Leading the Front Lines - North Carolina (Tealeaf-NC)
United States312 participantsStarted 2024-10-08
Plain-language 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).
Who can participate
Age range
5 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Acceptability of Intervention Measure (AIM) Scores
Timeframe: Month 0, Month 9
2
Mean Intervention Appropriateness Measure (IAM) Scores
Timeframe: Month 0, Month 9
3
Mean Feasibility of Intervention Measure (FIM) Scores
Timeframe: Month 0, Month 9
4
Mean Cause Analysis Chart (AABC) Evaluation Checklist Scores
Timeframe: Month 9
5
Mean 4Cs Behavior Plan Evaluation Checklist Scores
Timeframe: Month 9
6
Mean One-on-One Student Interaction Evaluation Tool Scores
Timeframe: Month 9
7
Mean One-on-One Family Interaction Evaluation Tool Scores