Teacher-Led Mental Health Care for Children

(Tealeaf-NC Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Not meeting inclusion criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

312 Participants Needed

Trial Summary

What is the purpose of 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).

Do I need to stop my current medications to join the trial?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Responding to Students' Emotions Through Education, Teachers Leading the Frontlines?

Research shows that teachers in Darjeeling, India, successfully delivered mental health care to children, with over 80% participation in intervention activities and improvements in children's mental health scores. Teachers effectively used their unique position to provide care, suggesting that education can serve as a form of mental health therapy. ^{1 2 3 4 5}

Is teacher-led mental health care for children safe?

The studies on teacher-led mental health care, like Tealeaf and RESEED, do not report any specific safety concerns, suggesting it is generally safe for children. Teachers delivering mental health care have been found acceptable by students, caregivers, and teachers themselves, indicating a positive reception without noted safety issues. ^{2 3 6 7 8}

How is the treatment 'Responding to Students' Emotions Through Education, Teachers Leading the Frontlines' different from other treatments for child mental health?

This treatment is unique because it involves teachers delivering mental health care directly to students, using their role to provide support and guidance in a school setting. Unlike traditional treatments that require trained mental health professionals, this approach leverages teachers' daily interactions with students to address mental health needs, making it more accessible in resource-limited settings. ^{1 2 3 7 9}

Research Team

Christina R Cruz, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for about 300 teachers in North Carolina, aiming to test a new system where teachers help with child mental health care. Teachers who are willing to adopt and maintain this program can join. Specific inclusion or exclusion criteria aren't provided.

Inclusion Criteria

I am a teacher over 18, teach K-8 for at least 1 hour/day and 4 days/week, with no child misconduct history.

I am a student in grades K-8 with a high score on the SDQ and have parental consent.

Schools that have been trained in either Tealeaf or RE-SEED in June 2024 after being randomized programmatically and are located in the State of North Carolina with an eligible principal

Exclusion Criteria

Exclusion criteria will be set as each participant does not meet the inclusion criteria as set for their group.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Teachers complete three days of training delivered by a mental health professional

1 week

3 visits (in-person)

Implementation

Teachers deliver task-shifted mental health care using the Tealeaf program throughout the school year

9 months

Monthly site visits, supplemented by as-needed telephone and digital discussions

Follow-up

Participants are monitored for effectiveness and fidelity of the intervention

1 month

Treatment Details

Interventions

• Responding to Students' Emotions Through Education
• Teachers Leading the Frontlines

Trial Overview The study tests 'Teachers Leading the Frontlines' and 'Responding to Students' Emotions Through Education'. It evaluates how well these approaches work (effectiveness), how they're adopted by schools, implemented over time, and maintained after the study ends.

Participant Groups

Group I: Tealeaf Experimental Treatment 1 Intervention

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

Group II: RE-SEED Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Doris Duke Charitable Foundation

Collaborator

Trials

65

Recruited

264,000+

Darjeeling Ladenla Road Prerna

Collaborator

Trials

3

Recruited

1,100+

Broadleaf Health and Education Alliance

Collaborator

Trials

4

Recruited

4,000+

Broadleaf Health and Education Alliance

Collaborator

Trials

4

Recruited

4,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Potential Emergence of "Education as Mental Health Therapy" as a Feasible Form of Teacher-Delivered Child Mental Health Care in a Low and Middle Income Country: A Mixed Methods Pragmatic Pilot Study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Teacher, caregiver, and student acceptability of teachers delivering task-shifted mental health care to students in Darjeeling, India: a mixed methods pilot study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Short Research Article: RESEED - the perceived impact of an enhanced usual care model of a novel, teacher-led, task-shifting initiative for child mental health. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of a training program that builds teachers' capability to identify and appropriately refer middle and high school students with mental health problems in Brazil: an exploratory study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Teacher Nomination of School-aged Children for Mental Health Services in a Low and Middle Income Country. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Students Having Parents with Mental Health Issues and Teachers' Mental Health Literacy]. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring Mental Health and Academic Outcomes of Children Receiving Non-manualized, Transdiagnostic, Task-Shifted Mental Health Care From Their Teachers in a Low-and-Middle Income Country. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Editorial Perspective: The new Special Educational Needs and Disability Code of Practice-an opportunity for school mental health services? [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

School-Based Mental Health Initiative: Potentials and Challenges for Child and Adolescent Mental Health. [2022]