Teachers Leading the Front Lines - North Carolina (Tealeaf-NC)

NCT06587230 | Recruiting

• 1 other identifier: 24-1034
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• 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.

  Month 0, Month 9

• 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.

  Month 0, Month 9

• 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.

  Month 0, Month 9

• 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.

  Month 9

• Mean 4Cs Behavior Plan Evaluation Checklist Scores

  The 4Cs Behavior Plan Evaluation Checklist is a study-specific tool that assists evaluators in scoring the fidelity with which teachers accurately complete the 4Cs Behavior Plan. 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.

  Month 9

• Mean One-on-One Student Interaction Evaluation Tool Scores

  The One-on-One Student Interaction Evaluation Tool is a study-specific tool that measures the fidelity with which teachers conduct one-on-one sessions with the student(s). Teachers are rated on six domains on a scale that ranges from 1 (Needs Improvement) to 5 (Advanced). Scores are averaged and rounded to a half point across domains to yield mean scores from 1 to 5 with a mean higher score indicating higher fidelity, and a mean score greater than or equal to 4 indicating sufficient fidelity.

  Month 9

• Mean One-on-One Family Interaction Evaluation Tool Scores

  The One-on-One Family Interaction Evaluation Tool is a study-specific tool that measures the fidelity with which teachers conduct family interactions. Teachers are rated on six domains on a scale that ranges from 1 (Needs improvement) to 5 (Advanced). Scores are averaged and rounded to a half point across domains to yield mean scores from 1 to 5 with a mean higher score indicating higher fidelity, and a mean score greater than or equal to 4 indicating sufficient fidelity.

  Month 9

Secondary Outcomes (3)

• Change in Strengths and Difficulties Questionnaire Total Difficulties Score

  Month 0, Month 9

• Mean Proportion of Attendance

  Up to 18 months

• Change in Academic Achievement

  Up to 18 months

Study Arms (2)

Tealeaf

EXPERIMENTAL

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

Behavioral: Teachers Leading the Frontlines

RE-SEED

ACTIVE COMPARATOR

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.

Behavioral: Responding to Students' Emotions Through Education

Interventions

Teachers Leading the Frontlines BEHAVIORAL

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.

Also known as: Tealeaf

Tealeaf

Responding to Students' Emotions Through Education BEHAVIORAL

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.

Also known as: RE-SEED

RE-SEED

Eligibility Criteria

• Age: 5 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Darjeeling Ladenla Road Prerna: collaborator
• Broadleaf Health and Education Alliance: collaborator
• University of Colorado, Denver: collaborator
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Related Publications (16)

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• Patel V, Kieling C, Maulik PK, Divan G. Improving access to care for children with mental disorders: a global perspective. Arch Dis Child. 2013 May;98(5):323-7. doi: 10.1136/archdischild-2012-302079. Epub 2013 Mar 9.

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• Shinde S, Weiss HA, Varghese B, Khandeparkar P, Pereira B, Sharma A, Gupta R, Ross DA, Patton G, Patel V. Promoting school climate and health outcomes with the SEHER multi-component secondary school intervention in Bihar, India: a cluster-randomised controlled trial. Lancet. 2018 Dec 8;392(10163):2465-2477. doi: 10.1016/S0140-6736(18)31615-5. Epub 2018 Nov 22.

  PMID: 30473365 BACKGROUND

• Burns BJ, Costello EJ, Angold A, Tweed D, Stangl D, Farmer EM, Erkanli A. Children's mental health service use across service sectors. Health Aff (Millwood). 1995 Fall;14(3):147-59. doi: 10.1377/hlthaff.14.3.147.

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  PMID: 33639109 BACKGROUND

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  PMID: 32319041 BACKGROUND

• Frontiers Production Office. Erratum: 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. Front Psychiatry. 2022 Jan 18;12:838044. doi: 10.3389/fpsyt.2021.838044. eCollection 2021.

  PMID: 35115975 BACKGROUND

• Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.

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• Cruz CM, Dukpa C, Vanderburg JL, Rauniyar AK, Giri P, Bhattarai S, Thapa A, Hampanda K, Gaynes BN, Lamb MM, Matergia M. Teacher, caregiver, and student acceptability of teachers delivering task-shifted mental health care to students in Darjeeling, India: a mixed methods pilot study. Discov Ment Health. 2022;2(1):21. doi: 10.1007/s44192-022-00024-z. Epub 2022 Oct 31.

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  PMID: 36927764 BACKGROUND

MeSH Terms

Conditions

Child Behavior; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms; Mental Disorders

Study Officials

• Christina R Cruz, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Cruz, MD

CONTACT

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

Michael Matergia, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will not be blinded; children must assent, and parents consent, to receive mental health care and teachers will be aware they are delivering care. One research assistant (RA) and staff mental health clinician will not be blinded to observe teachers' fidelity. Otherwise, personnel are blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be conducted as a two-arm, clustered trial evaluating the program implementation of the intervention (Tealeaf) that will be compared to an active comparator (RE-SEED). Schools will be randomized into either the full intervention or a lower-resourced version of the intervention. It is noted that schools are more willing to participate in an intervention trial if they will receive some benefit from their participation, leading to having a lower-resourced comparator rather than a true control comparator. Additionally, the active comparator ethically allows for identified children in need of care to have more resources than if no intervention occurred. Schools, teachers, and students will be followed prospectively with data collection at regular intervals.

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available beginning 12 and continuing for 36 months after publication to allow researchers to analyze data and submit for peer review.
• Access Criteria: Data will be deposited in UNC Odum Institute's UNC Dataverse, an open-source data repository service for the University of North Carolina at Chapel Hill (UNC) research community and its partners.

Locations

US (1)