Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06587230

Conditions

Child Behavior

Mental Health Issue

Psychosocial Functioning

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

Interventions

Teachers Leading the Frontlines

Responding to Students' Emotions Through Education

Study Details

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).

Conditions

Child Behavior

Mental Health Issue

Psychosocial Functioning

Depression

Anxiety

Study ID

NCT06587230

Start date

Oct 8, 2024

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

312 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Tealeaf

Teachers in the Tealeaf arm receive in-depth training and regular supervision and coaching from the study team.

active comparator: RE-SEED

Teachers in the RE-SEED arm receive much less in-depth training. The study team does not provide supervision allowing only the school counselor to provide supervision.

Interventions

Teachers Leading the Frontlines

1. 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

All 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.

Primary outcome measure

  • Mean Acceptability of Intervention Measure (AIM) Scores [ Time Frame: Month 0, Month 9 ]
  • Mean Intervention Appropriateness Measure (IAM) Scores [ Time Frame: Month 0, Month 9 ]
  • Mean Feasibility of Intervention Measure (FIM) Scores [ Time Frame: Month 0, Month 9 ]
  • Mean Cause Analysis Chart (AABC) Evaluation Checklist Scores [ Time Frame: Month 9 ]
  • Mean 4Cs Behavior Plan Evaluation Checklist Scores [ Time Frame: Month 9 ]
  • Mean One-on-One Student Interaction Evaluation Tool Scores [ Time Frame: Month 9 ]
  • Mean One-on-One Family Interaction Evaluation Tool Scores [ Time Frame: Month 9 ]

Central Contacts and Locations

Central contacts

Christina Cruz, MD

347-721-1458christina_cruz@med.unc.edu

Michael Matergia, MD

857-488-7209michael.matergia@broadleafhea.org

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Christina M Cruz, MD

347-721-1458christina_cruz@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-09-03.