Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587230
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Teachers Leading the Front Lines - North Carolina Tealeaf-NC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Building Teachers Mental Health Skills to Support Students With Mental Health Needs in Elementary and Middle Schools in North Carolina Program Implementation and Prospective Data Collection
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Tealeaf-NC
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-NCs Reach Adoption Implementation Primary Outcomes implementation-based as well as evaluating for preliminary indicators of Effectiveness Maintenance Secondary Outcomes clinically-based
Participants 300 estimated
Procedures This is a RE-AIM Reach Effectiveness Adoption Implementation Maintenance guided mixed methods clustered evaluation of Tealeaf-NCs Reach Adoption Implementation Primary Outcomes implementation-based as well as evaluating for preliminary indicators of Effectiveness Maintenance Secondary Outcomes clinically-based
Detailed Description:
Addressing childrens mental health is a critically important health challenge Twenty percent of all children suffer from significant mental health concerns most of whom will remain unrecognized unsupported and affected throughout their lives Such wide differences between mental health needs and care access are often called the care gap More recently a youth mental health crisis emerged alongside the COVID-19 pandemic The adverse impact of the pandemic has led to youth mental health prevalence increasing up to 40 in some global regions which is double the pre-pandemic rate while available professional mental health human resources have not changed leading to an even wider care gap As urgent solutions are needed alternative systems of care and support may address this urgent need in a more timely fashion than expanding traditional care systems would
The overarching goal of this study is to address the youth mental health crisis by providing evidence that high-quality alternative sustainable child mental health care may improve youth mental health symptoms This proposal aims to pilot a novel alternative potentially sustainable system of teacher-delivered task-shifted child mental health care In North Carolina USA the investigators will pilot Teachers Leading the Frontlines - Mansik Swastha Mental Health in Nepali Tealeaf Created in Darjeeling India Tealeaf centers on training and supervising elementary school teachers to deliver education as mental health therapy Ed-MH to children ages 5-12 Ed-MH is the investigators novel task-shifting therapy modality that minimizes the time teachers need to deliver care by fitting it into their work In Ed-MH teachers use evidence-based therapeutic techniques adapted for use in their existing interactions with students in need eg while teaching and streamlined for care for any diagnosis transdiagnostic
The investigators rationale stems from two trials in Darjeeling where the mental health symptoms of children in Tealeaf improved from clinical to neurotypical The investigators specifically aim to determine if teachers can deliver Tealeaf with fidelity with positive acceptability feasibility for stakeholders and leading to preliminary indicators of improved child mental health outcomes Guided by the RE-AIM Reach Effectiveness Adoption Implementation Maintenance public health framework the investigators hypothesize that a pilot of Tealeaf clustered at the school level will show that
1 Teachers can deliver Tealeaf task-shifted mental health care fitted into their work with higher fidelity than the active comparator and stakeholders teachers students parents principals will find Tealeaf more acceptable feasible than the active comparator Reach Adoption Implementation Primary Outcomes
2 Tealeaf will show early signs of greater impact on childrens 1 mental health symptoms 2 academic achievement and 3 school attendance versus a comparator Effectiveness Maintenance Secondary Outcomes
Researchers will compare Tealeaf with an active comparator RE-SEED Responding to Students Emotions through Education to see if a lower-resourced version of Tealeaf is viable andor has an impact
Tealeaf has six components implemented over a school year
1 Teachers first complete three days of training delivered by a mental health professional eg psychiatric social worker psychologist or psychiatrist
2 Teachers use a study-specific tool the Behavior Type and Severity Tool BTST to systematically capture their impression of each student in their class Using their judgment aided by the BTST teachers select students whom they believe have the highest mental health needs to receive care
3 Teachers observe chosen students symptoms with the Strengths and Difficulties Questionnaire If the child has a positive total or subscale score they are eligible for the study The target enrollment of 2 students per teacher based on estimated prevalence and teacher feedback on a feasible case load
4 Teachers understand students behavior using the Activating Event Automatic Thoughtor Feeling Behavior and Consequence Chart AABC Chart and the Themes of the AABC Chart tool These tools are similar to the Antecedent Behavior and Consequences ABC Chart from Cognitive Behavior Therapy CBT
5 Teachers develop a targeted response using a plan called the 4Cs Cause Change Connect and Cultivate plan The chosen care framework for addressing behavior and mental health and that the 4Cs was modeled on are behavior plans not manualized care They align with how teachers already individualize teaching to students needs The 4Cs goal is to improve mental health through and in addition to learning whereas typical behavior plans solely target improved learning In the 4Cs teachers select therapeutic techniques to deliver from a menu of evidence-based therapeutic options for each category of behavior Ed-MH adapts Cognitive Behavior Play Therapy CBPT and Dialectical Behavior Therapy DBT measures for classroom delivery Based on CBT CBPT is accessible to children 10 years old using both talk and play therapy There are two chosen areas of therapeutic focus for teachers 1 Behavioral activation and self-regulation are guided by the teachers as they occur in the classroom 2 Cognitive restructuring is incorporated through traditional means AABC Chart
6 The remainder of the school year is dedicated to the development of therapeutic relationships and the delivery of therapeutic interactions and skills practice Revisions to the 4Cs plan are made based on each childs progress As a key component of task-shifting teachers receive supervision through monthly site visits supplemented by as-needed telephone and digital discussions to guide their care from the study team This supervision occurs throughout the year Trained school counselors can also provide monthly supervision or as needed Teachers encourage the use of the 4Cs plan at home
For RE-SEED active comparator processes are similar to Tealeaf The differences are that training is 1-day such that they receive markedly less in-depth knowledge and the study team does not provide supervision allowing only the counselor to provide supervision This less resource-intensive approach will allow for an ethical comparator to Tealeaf where schools would like for teachers to have some skills to support identified students as part of their willingness to participate in research while also allowing the investigators to begin to understand what impact fewer resources may have versus a full intervention
Tealeaf and Ed-MHs mechanism of action for improving mental health symptoms is through teachers guiding children to consistently practice coping skills and emotion regulation for long periods a school day and in real-time in moments of concern Like counselors Tealeaf teachers help students gain insight and acquire coping skills Teachers take the therapy activities further though by overseeing children practicing coping skills reinforcing positive behavior and supporting them in moments of struggle all in real-time It is ideally how teachers would work with students as guided by a therapist but here they determine how to therapeutically respond to a students mental health needs since therapists are inaccessible Moreover as a role model teachers already play a key role in the social emotional and academic development of students and interact with them individually in moments of concern Ed-MH allows teachers to deliver therapy in shared moments in real time Professional and lay counselors instead can only reflect from afar on moments the student is willing to share in the office
A second mechanism of action is through teachers delivering care that can target education symptoms of mental health as seen in India For example a student may have poor schoolwork due to anxiety Their teacher can target their poor schoolwork the education symptoms of their mental health and anxiety by improving schoolwork quality an education intervention by building their capacity to complete assignments gradually ie exposure therapy an evidence-based technique After care both symptoms improved
Intervention evidence Results from 2018 and 2019 pilot Tealeaf trials show that mental health care delivery for children can be shifted to teachers
1 Teachers n19 nominated students n36 with moderate accuracy 72 sensitivity and 62 specificity aligned with identification by lay counselors in Low- or Middle- Income Countries LMIC and teachers in High-Income Countries HIC
2 Teachers n19 delivered care with fidelity on average at or above 60 fidelity to protocol similar to mental health professionals fidelity to new therapies
3 Teachers n19 found it feasible to deliver therapy when integrated into their workflow Ed-MH citing the choice of therapeutic techniques and the ability to incorporate them into teaching
4 Teachers families and students found it acceptable for teachers to deliver mental health care Teachers cited flexible care delivery families cited impact and students cited being treated well
5 Childrens mental health symptoms improved after receiving Ed-MH from their teachers an early signal of impact Symptoms improved on average from clinical to neurotypical ie from the 77th to the 60th percentile baseline to end line on a gold standard measure in 2018 n36 and from the 84th to the 68th percentile in 2019 n26 While supported children in 2019 had neurotypical symptom levels at the end line children receiving enhanced usual care n188 remained at clinical levels 81st percentile effect size 07 These findings support teachers delivery of task-shifted indicated child mental health care that is transdiagnostic and integrated into their work
Overall our prior research demonstrates that teacher-delivered transdiagnostic mental health care Tealeaf inclusive of Ed-MH may be a potentially efficient sustainable and impactful approach A Type 1 hybrid effectiveness-implementation Tealeaf trial is ongoing in Darjeeling India
The investigators rationale for pilot testing Tealeaf-NC is based on Tealeafs promising results as there is an urgent need to identify and deliver evidence-based childrens mental health interventions to tackle the childrens mental health care gap that worsened into a crisis during the COVID pandemic Of note Tealeaf skipped over efficacy lab-like setting to effectiveness testing real world as literature supports skipping efficacy testing of task-shifted mental health care Task-shifting improves mental health outcomes in lab-like settings and is now recommended to be tested in specific forms eg teacher-delivery for specific contexts to study its effects in real-world practice As research evidence takes an average of 17 years to reach clinical practice and given Tealeafs promise the urgent need justifies pilot testing Tealeafs potential implementation and clinical outcomes in new settings
The overarching goal of this study is to address the youth mental health crisis by providing evidence that high-quality alternative sustainable child mental health care may improve youth mental health symptoms This proposal aims to pilot a novel alternative potentially sustainable system of teacher-delivered task-shifted child mental health care In North Carolina USA the investigators will pilot Teachers Leading the Frontlines - Mansik Swastha Mental Health in Nepali Tealeaf Created in Darjeeling India Tealeaf centers on training and supervising elementary school teachers to deliver education as mental health therapy Ed-MH to children ages 5-12 Ed-MH is the investigators novel task-shifting therapy modality that minimizes the time teachers need to deliver care by fitting it into their work In Ed-MH teachers use evidence-based therapeutic techniques adapted for use in their existing interactions with students in need eg while teaching and streamlined for care for any diagnosis transdiagnostic
The investigators rationale stems from two trials in Darjeeling where the mental health symptoms of children in Tealeaf improved from clinical to neurotypical The investigators specifically aim to determine if teachers can deliver Tealeaf with fidelity with positive acceptability feasibility for stakeholders and leading to preliminary indicators of improved child mental health outcomes Guided by the RE-AIM Reach Effectiveness Adoption Implementation Maintenance public health framework the investigators hypothesize that a pilot of Tealeaf clustered at the school level will show that
1 Teachers can deliver Tealeaf task-shifted mental health care fitted into their work with higher fidelity than the active comparator and stakeholders teachers students parents principals will find Tealeaf more acceptable feasible than the active comparator Reach Adoption Implementation Primary Outcomes
2 Tealeaf will show early signs of greater impact on childrens 1 mental health symptoms 2 academic achievement and 3 school attendance versus a comparator Effectiveness Maintenance Secondary Outcomes
Researchers will compare Tealeaf with an active comparator RE-SEED Responding to Students Emotions through Education to see if a lower-resourced version of Tealeaf is viable andor has an impact
Tealeaf has six components implemented over a school year
1 Teachers first complete three days of training delivered by a mental health professional eg psychiatric social worker psychologist or psychiatrist
2 Teachers use a study-specific tool the Behavior Type and Severity Tool BTST to systematically capture their impression of each student in their class Using their judgment aided by the BTST teachers select students whom they believe have the highest mental health needs to receive care
3 Teachers observe chosen students symptoms with the Strengths and Difficulties Questionnaire If the child has a positive total or subscale score they are eligible for the study The target enrollment of 2 students per teacher based on estimated prevalence and teacher feedback on a feasible case load
4 Teachers understand students behavior using the Activating Event Automatic Thoughtor Feeling Behavior and Consequence Chart AABC Chart and the Themes of the AABC Chart tool These tools are similar to the Antecedent Behavior and Consequences ABC Chart from Cognitive Behavior Therapy CBT
5 Teachers develop a targeted response using a plan called the 4Cs Cause Change Connect and Cultivate plan The chosen care framework for addressing behavior and mental health and that the 4Cs was modeled on are behavior plans not manualized care They align with how teachers already individualize teaching to students needs The 4Cs goal is to improve mental health through and in addition to learning whereas typical behavior plans solely target improved learning In the 4Cs teachers select therapeutic techniques to deliver from a menu of evidence-based therapeutic options for each category of behavior Ed-MH adapts Cognitive Behavior Play Therapy CBPT and Dialectical Behavior Therapy DBT measures for classroom delivery Based on CBT CBPT is accessible to children 10 years old using both talk and play therapy There are two chosen areas of therapeutic focus for teachers 1 Behavioral activation and self-regulation are guided by the teachers as they occur in the classroom 2 Cognitive restructuring is incorporated through traditional means AABC Chart
6 The remainder of the school year is dedicated to the development of therapeutic relationships and the delivery of therapeutic interactions and skills practice Revisions to the 4Cs plan are made based on each childs progress As a key component of task-shifting teachers receive supervision through monthly site visits supplemented by as-needed telephone and digital discussions to guide their care from the study team This supervision occurs throughout the year Trained school counselors can also provide monthly supervision or as needed Teachers encourage the use of the 4Cs plan at home
For RE-SEED active comparator processes are similar to Tealeaf The differences are that training is 1-day such that they receive markedly less in-depth knowledge and the study team does not provide supervision allowing only the counselor to provide supervision This less resource-intensive approach will allow for an ethical comparator to Tealeaf where schools would like for teachers to have some skills to support identified students as part of their willingness to participate in research while also allowing the investigators to begin to understand what impact fewer resources may have versus a full intervention
Tealeaf and Ed-MHs mechanism of action for improving mental health symptoms is through teachers guiding children to consistently practice coping skills and emotion regulation for long periods a school day and in real-time in moments of concern Like counselors Tealeaf teachers help students gain insight and acquire coping skills Teachers take the therapy activities further though by overseeing children practicing coping skills reinforcing positive behavior and supporting them in moments of struggle all in real-time It is ideally how teachers would work with students as guided by a therapist but here they determine how to therapeutically respond to a students mental health needs since therapists are inaccessible Moreover as a role model teachers already play a key role in the social emotional and academic development of students and interact with them individually in moments of concern Ed-MH allows teachers to deliver therapy in shared moments in real time Professional and lay counselors instead can only reflect from afar on moments the student is willing to share in the office
A second mechanism of action is through teachers delivering care that can target education symptoms of mental health as seen in India For example a student may have poor schoolwork due to anxiety Their teacher can target their poor schoolwork the education symptoms of their mental health and anxiety by improving schoolwork quality an education intervention by building their capacity to complete assignments gradually ie exposure therapy an evidence-based technique After care both symptoms improved
Intervention evidence Results from 2018 and 2019 pilot Tealeaf trials show that mental health care delivery for children can be shifted to teachers
1 Teachers n19 nominated students n36 with moderate accuracy 72 sensitivity and 62 specificity aligned with identification by lay counselors in Low- or Middle- Income Countries LMIC and teachers in High-Income Countries HIC
2 Teachers n19 delivered care with fidelity on average at or above 60 fidelity to protocol similar to mental health professionals fidelity to new therapies
3 Teachers n19 found it feasible to deliver therapy when integrated into their workflow Ed-MH citing the choice of therapeutic techniques and the ability to incorporate them into teaching
4 Teachers families and students found it acceptable for teachers to deliver mental health care Teachers cited flexible care delivery families cited impact and students cited being treated well
5 Childrens mental health symptoms improved after receiving Ed-MH from their teachers an early signal of impact Symptoms improved on average from clinical to neurotypical ie from the 77th to the 60th percentile baseline to end line on a gold standard measure in 2018 n36 and from the 84th to the 68th percentile in 2019 n26 While supported children in 2019 had neurotypical symptom levels at the end line children receiving enhanced usual care n188 remained at clinical levels 81st percentile effect size 07 These findings support teachers delivery of task-shifted indicated child mental health care that is transdiagnostic and integrated into their work
Overall our prior research demonstrates that teacher-delivered transdiagnostic mental health care Tealeaf inclusive of Ed-MH may be a potentially efficient sustainable and impactful approach A Type 1 hybrid effectiveness-implementation Tealeaf trial is ongoing in Darjeeling India
The investigators rationale for pilot testing Tealeaf-NC is based on Tealeafs promising results as there is an urgent need to identify and deliver evidence-based childrens mental health interventions to tackle the childrens mental health care gap that worsened into a crisis during the COVID pandemic Of note Tealeaf skipped over efficacy lab-like setting to effectiveness testing real world as literature supports skipping efficacy testing of task-shifted mental health care Task-shifting improves mental health outcomes in lab-like settings and is now recommended to be tested in specific forms eg teacher-delivery for specific contexts to study its effects in real-world practice As research evidence takes an average of 17 years to reach clinical practice and given Tealeafs promise the urgent need justifies pilot testing Tealeafs potential implementation and clinical outcomes in new settings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None