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

BEHAVIORAL

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.

BEHAVIORAL

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.

Mean Acceptability of Intervention Measure (AIM) Scores

Time frame: Month 0, Month 9

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.

Mean Intervention Appropriateness Measure (IAM) Scores

Time frame: Month 0, Month 9

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.

Mean Feasibility of Intervention Measure (FIM) Scores

Time frame: Month 0, Month 9

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.

Mean Cause Analysis Chart (AABC) Evaluation Checklist Scores

Time frame: Month 9

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.

Mean 4Cs Behavior Plan Evaluation Checklist Scores

Time frame: Month 9

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.

Mean One-on-One Student Interaction Evaluation Tool Scores

Time frame: Month 9

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.

Mean One-on-One Family Interaction Evaluation Tool Scores

Time frame: Month 9

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.