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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06587230
Status
Recruiting
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Conditions

  • Anxiety
  • Child Behavior
  • Depression
  • Mental Health Issue
  • Psychosocial Functioning

Eligibility Criteria

Sex
ALL
Age
5 Years - 99 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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).

Key Dates

Start date
Oct 8, 2024
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
312 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Mean Acceptability of Intervention Measure (AIM) Scores [ Time Frame: Month 0, Month 9 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Christina M Cruz, MD
[email protected]
347-721-1458

Find similar trials in Chapel Hill, NC

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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