Teachers Leading the Front Lines - North Carolina (Tealeaf-NC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-99
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
>18 years old
Disqualifiers
Exclusion criteria will be set as each participant does not meet the inclusion criteria as set for their group.
Trial design
Design model
Parallel
Treatments tested in this trial
Teachers Leading the Frontlines
Behavioral1. During 3-day training, Knowledge and attitudes toward child mental health care are measured pre-training, post-training, and post-intervention. 2. The teachers select students whom they believe have the highest mental health needs to receive care. 3. Teachers analyze chosen students' symptoms. 4. Teachers analyze students' behavior with the AABC Chart. 5. Teachers develop a targeted response using a behavior plan called the 4Cs plan (Cause, Change, Connect, and Cultivate). In the 4Cs, teachers select therapeutic techniques to deliver from a menu of evidence-based therapeutic options for each category of behavior. 6. Throughout the year, teachers receive supervision through monthly site visits supplemented by as-needed telephone and digital discussions to guide their care from the study team. Teachers encourage the use of the 4Cs plan at home.
Responding to Students' Emotions Through Education
BehavioralAll processes for RE-SEED are the same as in Tealeaf except... 1. Teachers receive only 1 day of training 2. The study team does not provide supervision to the teachers, allowing only the school counselor to provide supervision This less resource-intensive approach will allow for an ethical comparator to Tealeaf, where the schools would like for teachers to have some skills to support identified students.
Treatment groups
312 Participants
are divided into 2 treatment groupsGroup A: TealeafExperimental treatment 1 intervention
Group B: RE-SEEDActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean Acceptability of Intervention Measure (AIM) Scores
The Acceptability of Intervention Measure (AIM) measures the stakeholder's beliefs about the acceptability of the assigned intervention. Each element is scored from 1 (Completely disagree) to 5 (Completely agree). Mean scores are calculated, with a higher score indicating that the teacher believes the intervention is more acceptable, and a score greater than or equal to 4 indicating positive acceptability.
Time frame
Month 0, Month 92
Mean Intervention Appropriateness Measure (IAM) Scores
The Intervention Appropriateness Measure (IAM) measures the stakeholder's beliefs about the appropriateness of the assigned intervention. Each element is scored from 1 (Completely disagree) to 5 (Completely Agree). Mean scores are calculated, with a higher score indicating that the teacher believes the intervention is more appropriate, and a score greater than or equal to 4 indicating the intervention is more appropriate.
Time frame
Month 0, Month 93
Mean Feasibility of Intervention Measure (FIM) Scores
The Feasibility of Intervention Measure (FIM) measured the stakeholder's beliefs about the feasibility of the assigned intervention. Each element is scored from 1 (Completely disagree) to 5 (Completely agree). Mean scores are calculated, with a higher score indicating that the teacher believes the intervention is more feasible, and a score greater than or equal to 4 indicating positive feasibility.
Time frame
Month 0, Month 94
Mean Cause Analysis Chart (AABC) Evaluation Checklist Scores
The Cause Analysis Chart (AABC) Evaluation Checklist is a study-specific tool that assists evaluators in scoring the fidelity with which teachers accurately complete the AABC Chart. Mean scores are calculated and can range from 1 (Needs improvement) to 5 (Advanced) with a higher mean score indicating higher fidelity, and an overall mean score greater than or equal to 4 indicating sufficient fidelity.
Time frame
Month 9Secondary outcomes
1
Change in Strengths and Difficulties Questionnaire Total Difficulties Score
The Strengths and Difficulties Questionnaire is a brief behavioral screening that will measure the mental health of students, and the change in scores will measure the effectiveness of the assigned intervention. The total difficulties score is the summation of 4 subscales: emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems. Each subscale has 5 items scored as "Not True," "Somewhat True," and "Certainly True" yielding a value of 0,1, or 2. (Some items are scored in reverse). The total difficulties score is generated by summing scores from each scale to yield an overall score. The overall score range is from 0-40, with a higher score indicating more difficulties/worse mental health. A bigger decrease in the total difficulties scores will indicate that the intervention is more effective.
Time frame
Month 0, Month 92
Mean Proportion of Attendance
Using the teachers' and school records, the number of days present will be converted to a proportion of days in attendance (due to the varied length of academic school years). These proportions will be compared between arms, and a higher proportion of attendance will indicate a more effective intervention.
Time frame
Up to 18 months3
Change in Academic Achievement
Using the teachers' and school records, a change in student academic achievement score will be coded from available grades, assessment, discipline and IEP/504 information. A significant change in the positive direction will indicate an effective intervention.
Time frame
Up to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
Darjeeling Ladenla Road Prerna
Collaborator
Broadleaf Health and Education Alliance
Collaborator
University of Colorado, Denver
Collaborator
Doris Duke Charitable Foundation
Collaborator
Source ClinicalTrials.gov