Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-01-31
Brief Title:
Teachers Leading the Front Lines - Adolescent
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Teachers Delivering Task-Shifted Mental Health Care to Adolescents in India
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TeaLeaf-A
Brief Summary:
Purpose The purpose of this research is to pilot test a novel alternative potentially sustainable system of teacher-delivered task-shifted adolescent mental health care
Participants Principals of 60 rural low-cost private secondary schools of the Darjeeling Himalayas will be invited to participate as a school and an individual Teachers will be approached individually Two students per teacher who meet inclusion criteria will be randomly chosen for enrollment
Procedures This is a RE-AIM Reach Effectiveness Adoption Implementation Maintenance guided mixed methods CRCT clustered at schools of Tealeaf-As Reach Adoption Implementation Primary Outcomes implementation-based as well as evaluating for preliminary indicators of Effectiveness Maintenance Secondary Outcomes clinically-based
Participants Principals of 60 rural low-cost private secondary schools of the Darjeeling Himalayas will be invited to participate as a school and an individual Teachers will be approached individually Two students per teacher who meet inclusion criteria will be randomly chosen for enrollment
Procedures This is a RE-AIM Reach Effectiveness Adoption Implementation Maintenance guided mixed methods CRCT clustered at schools of Tealeaf-As Reach Adoption Implementation Primary Outcomes implementation-based as well as evaluating for preliminary indicators of Effectiveness Maintenance Secondary Outcomes clinically-based
Detailed Description:
The overarching goal of this proposal is to address the youth mental health crisis by increasing access to high quality alternative sustainable adolescent mental health care The overall objective of this proposal is to pilot test a novel alternative potentially sustainable system of teacher-delivered task-shifted adolescent mental health care In Darjeeling India the investigators will test Tealeaf Teachers Leading the Frontlines - Mansik Swastha Mental Health in Nepali as adapted for adolescents Tealeaf-Adolescent Tealeaf-A Created in Darjeeling Tealeaf centers on training and supervising elementary school teachers to deliver education as mental health therapy Ed-MH to children age 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 work8 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 Tealeaf-As adaptation inclusive of Ed-MH is supported by a Doris Duke Charitable Foundation DDCF Fund to Retain Clinical
Scientists FRCS Caregivers at Carolina COVID Corona Virus Disease award The investigators central hypotheses are that teachers can deliver Tealeaf-A task-shifted mental health care fitted into their work with fidelity stakeholders teachers adolescents parents principals will find Tealeaf-A acceptable feasible and adolescents in Tealeaf-A will show preliminary indicators of mental health symptom improvement versus a comparator The investigators rationale stems from two trials in Darjeeling where mental health symptoms of children in Tealeaf improved from clinical to neurotypical The investigators propose a mixed methods explanatory sequential study collecting quantitative QUAN then qualitative data qual to explain QUAN QUAN-qual The investigators specific aims are
1 To determine if teachers can deliver Tealeaf-A with fidelity with positive acceptability feasibility for stakeholders and leading to preliminary indicators of improved adolescent mental health outcomes QUAN Guided by the RE-AIM Reach Effectiveness Adoption Implementation Maintenance framework the investigators hypothesize that a pilot cluster randomized controlled trial CRCT of Tealeaf-A clustered at the school level n6 schools 72 teachers 144 students will show that
Hypothesis 1a H1a Teachers can deliver Tealeaf-A with fidelity and positive feasibility acceptability for stakeholders Reach Adoption Implementation Primary Outcomes and
Hypothesis 1b H1b Adolescents in Tealeaf-A will have preliminary indicators of improved student mental health symptoms versus a comparator Effectiveness Maintenance Secondary Outcomes
2 To explore under what circumstances teachers can deliver Tealeaf-A with fidelity with positive acceptability feasibility for stakeholders and that leads to preliminary indicators of improved adolescent mental health outcomes qual QUAN - qual Guided by the Consolidated Framework for Implementation Research CFIR the investigators will explore the role of intervention and contextual factors in Aim 1 outcomes by completing key informant interviews with randomly selected stakeholders stratified by stakeholder group school and trial arm n42 3 months Post intervention Mixed methods data integration will occur in side-by-side QUAN-qual joint display tables As this Aim is exploratory it does not have a hypothesis to test Based on previous results and review of the literature though the investigators discuss in Aim 2 in Research Design Methods the anticipated findings
Tealeaf-A Adaptation
Implemented over a school year Tealeaf has six components 1 Teachers first complete six days of training on components 2-6 delivered by the investigators local collaborators team DLRP of psychiatric social workers with 8 years of experience with Tealeaf 2 Teachers then nominate students for care based on their judgment grounded in their everyday interactions with students This method was chosen based on accuracy as in Evidence and to avoid 11 screenings that may identify to others which students need mental health support 3 They next analyze these students symptoms with basic functional behavioral assessments 4 Informed by behavior analyses they then develop an individualized response using the 4Cs plan Cause Change Connect and Cultivate Behavior plans 4Cs are the chosen care framework not manualized care as they align with how teachers individualize teaching to students needs The goal of the 4Cs is to improve mental health through and in addition to learning whereas typical behavior plans solely target improved learning Teachers have improved learning but not mental health symptoms when individualizing pedagogy using behavior plans individualization alone was not sufficient In the 4Cs teachers pick transdiagnostic therapeutic techniques to deliver from an Ed-MH menu of evidence-based options For children Tealeafs current target Ed-MH adapts Cognitive Behavior Play Therapy CBPT measures for classroom delivery Based in Cognitive Behavior Therapy CBT CBPT is accessible to children 10 years old using both talk and play therapy Play therapy for children and CBT for youth 10 years old have repeatedly improved symptoms Ed-MH techniques include managing behaviors in class 11 sessions and adjusting knowledge transfer processes 5 Working with caregivers as they see fit as professional clinicians do teachers encourage 4Cs use at home 6 Teachers deliver Ed-MH over a school year with supervision every two weeks and guided by iterative 4Cs as students needs evolve
The investigators adapted Tealeaf to address adolescent needs Tealeaf-A in 2022 with support from a DDCF FRCS award Adaptations to better target adolescents include 1 changing Ed-MH techniques from CBPT to CBT ie abstract cognitive concepts rather than play approaches 2 modifying Tealeafs structure as students have different teachers for different subjects where 1 teacher will be the lead and coordinate with other teachers 3 newly compensating teachers given this additional coordination and for caring for more students since each teacher sees more students as subject teachers and 4 enhancing confidentiality Confidentiality adaptations included 4a focusing Ed-MH techniques on homework changes rather than classwork to avoid in-class additional attention 4b limiting what is shared with caregivers to safety information and 4c having discrete spaces in schools to meet 11
Tealeaf and Ed-MHs mechanism of action for improving mental health symptoms is through teachers guiding adolescents to consistently practice coping skills and emotion regulation for long periods of time a school day and in real time in the moments of concern Like counselors Tealeaf teachers help students gain insight and acquire coping skills Teachers take the therapy activities farther though by overseeing adolescents 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 themselves determine how to therapeutically respond to a students mental health needs since therapists are rare 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 In the Ed-MH example in Background the student had poor schoolwork due to anxiety His teacher can target his poor schoolwork the education symptom of his mental health and anxiety by improving schoolwork quality an education intervention through building his capacity to complete assignments gradually ie exposure therapy an evidence-based therapy 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 LMICs Low- or Middle-Income Countries and teachers in HICs High-Income Countries 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 choice of therapeutic techniques and the ability to incorporate them into teaching4 Teachers families and students found it acceptable for teachers to deliver mental health careTeachers 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 end line children receiving enhanced usual care n188 remained at clinical levels 81st percentile These findings support teachers delivery of task-shifted indicated child mental health care that is transdiagnostic and integrated into their work This structure is similar to teacher-delivered adolescent promotion and prevention that has improved mental health outcomes Thus a next logical step is to test teachers delivery of indicated adolescent care structured similarly to 1 adolescent prevention promotion and 2 indicated childrens care
The investigators rationale for pilot testing Tealeaf-A is based on Tealeafs promising results as there is an urgent need to identify and deliver evidence-based adolescent mental health interventions to tackle the adolescent mental health care gap that worsened into a crisis during the COVID pandemic Adapting Tealeaf to adolescents and its testing would occur ideally after completing the investigators Type 1 hybrid effectiveness-implementation trial of Tealeaf for children ongoing in year 2 of 4 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 The high risk of poor care access such as disability to a large population of adolescents justifies Tealeafs accelerated testing based on its promise Also recent implementation science literature supports parallel trials of the same intervention to accelerate research translation into practice since evidence takes 17 years on average to reach clinical practice Supported by literature creating Tealeaf-A given promising results was then supported by a DDCF FRCS award further substantiating the accelerated pursuit of Tealeaf-A Also Tealeaf-A care delivery would ideally include teachers and peers Due to resource limitations and prioritizing indicated over complementary care a teacher-led Tealeaf-A adaptation was prioritized A grant is pending to develop a peer component
Scientists FRCS Caregivers at Carolina COVID Corona Virus Disease award The investigators central hypotheses are that teachers can deliver Tealeaf-A task-shifted mental health care fitted into their work with fidelity stakeholders teachers adolescents parents principals will find Tealeaf-A acceptable feasible and adolescents in Tealeaf-A will show preliminary indicators of mental health symptom improvement versus a comparator The investigators rationale stems from two trials in Darjeeling where mental health symptoms of children in Tealeaf improved from clinical to neurotypical The investigators propose a mixed methods explanatory sequential study collecting quantitative QUAN then qualitative data qual to explain QUAN QUAN-qual The investigators specific aims are
1 To determine if teachers can deliver Tealeaf-A with fidelity with positive acceptability feasibility for stakeholders and leading to preliminary indicators of improved adolescent mental health outcomes QUAN Guided by the RE-AIM Reach Effectiveness Adoption Implementation Maintenance framework the investigators hypothesize that a pilot cluster randomized controlled trial CRCT of Tealeaf-A clustered at the school level n6 schools 72 teachers 144 students will show that
Hypothesis 1a H1a Teachers can deliver Tealeaf-A with fidelity and positive feasibility acceptability for stakeholders Reach Adoption Implementation Primary Outcomes and
Hypothesis 1b H1b Adolescents in Tealeaf-A will have preliminary indicators of improved student mental health symptoms versus a comparator Effectiveness Maintenance Secondary Outcomes
2 To explore under what circumstances teachers can deliver Tealeaf-A with fidelity with positive acceptability feasibility for stakeholders and that leads to preliminary indicators of improved adolescent mental health outcomes qual QUAN - qual Guided by the Consolidated Framework for Implementation Research CFIR the investigators will explore the role of intervention and contextual factors in Aim 1 outcomes by completing key informant interviews with randomly selected stakeholders stratified by stakeholder group school and trial arm n42 3 months Post intervention Mixed methods data integration will occur in side-by-side QUAN-qual joint display tables As this Aim is exploratory it does not have a hypothesis to test Based on previous results and review of the literature though the investigators discuss in Aim 2 in Research Design Methods the anticipated findings
Tealeaf-A Adaptation
Implemented over a school year Tealeaf has six components 1 Teachers first complete six days of training on components 2-6 delivered by the investigators local collaborators team DLRP of psychiatric social workers with 8 years of experience with Tealeaf 2 Teachers then nominate students for care based on their judgment grounded in their everyday interactions with students This method was chosen based on accuracy as in Evidence and to avoid 11 screenings that may identify to others which students need mental health support 3 They next analyze these students symptoms with basic functional behavioral assessments 4 Informed by behavior analyses they then develop an individualized response using the 4Cs plan Cause Change Connect and Cultivate Behavior plans 4Cs are the chosen care framework not manualized care as they align with how teachers individualize teaching to students needs The goal of the 4Cs is to improve mental health through and in addition to learning whereas typical behavior plans solely target improved learning Teachers have improved learning but not mental health symptoms when individualizing pedagogy using behavior plans individualization alone was not sufficient In the 4Cs teachers pick transdiagnostic therapeutic techniques to deliver from an Ed-MH menu of evidence-based options For children Tealeafs current target Ed-MH adapts Cognitive Behavior Play Therapy CBPT measures for classroom delivery Based in Cognitive Behavior Therapy CBT CBPT is accessible to children 10 years old using both talk and play therapy Play therapy for children and CBT for youth 10 years old have repeatedly improved symptoms Ed-MH techniques include managing behaviors in class 11 sessions and adjusting knowledge transfer processes 5 Working with caregivers as they see fit as professional clinicians do teachers encourage 4Cs use at home 6 Teachers deliver Ed-MH over a school year with supervision every two weeks and guided by iterative 4Cs as students needs evolve
The investigators adapted Tealeaf to address adolescent needs Tealeaf-A in 2022 with support from a DDCF FRCS award Adaptations to better target adolescents include 1 changing Ed-MH techniques from CBPT to CBT ie abstract cognitive concepts rather than play approaches 2 modifying Tealeafs structure as students have different teachers for different subjects where 1 teacher will be the lead and coordinate with other teachers 3 newly compensating teachers given this additional coordination and for caring for more students since each teacher sees more students as subject teachers and 4 enhancing confidentiality Confidentiality adaptations included 4a focusing Ed-MH techniques on homework changes rather than classwork to avoid in-class additional attention 4b limiting what is shared with caregivers to safety information and 4c having discrete spaces in schools to meet 11
Tealeaf and Ed-MHs mechanism of action for improving mental health symptoms is through teachers guiding adolescents to consistently practice coping skills and emotion regulation for long periods of time a school day and in real time in the moments of concern Like counselors Tealeaf teachers help students gain insight and acquire coping skills Teachers take the therapy activities farther though by overseeing adolescents 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 themselves determine how to therapeutically respond to a students mental health needs since therapists are rare 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 In the Ed-MH example in Background the student had poor schoolwork due to anxiety His teacher can target his poor schoolwork the education symptom of his mental health and anxiety by improving schoolwork quality an education intervention through building his capacity to complete assignments gradually ie exposure therapy an evidence-based therapy 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 LMICs Low- or Middle-Income Countries and teachers in HICs High-Income Countries 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 choice of therapeutic techniques and the ability to incorporate them into teaching4 Teachers families and students found it acceptable for teachers to deliver mental health careTeachers 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 end line children receiving enhanced usual care n188 remained at clinical levels 81st percentile These findings support teachers delivery of task-shifted indicated child mental health care that is transdiagnostic and integrated into their work This structure is similar to teacher-delivered adolescent promotion and prevention that has improved mental health outcomes Thus a next logical step is to test teachers delivery of indicated adolescent care structured similarly to 1 adolescent prevention promotion and 2 indicated childrens care
The investigators rationale for pilot testing Tealeaf-A is based on Tealeafs promising results as there is an urgent need to identify and deliver evidence-based adolescent mental health interventions to tackle the adolescent mental health care gap that worsened into a crisis during the COVID pandemic Adapting Tealeaf to adolescents and its testing would occur ideally after completing the investigators Type 1 hybrid effectiveness-implementation trial of Tealeaf for children ongoing in year 2 of 4 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 The high risk of poor care access such as disability to a large population of adolescents justifies Tealeafs accelerated testing based on its promise Also recent implementation science literature supports parallel trials of the same intervention to accelerate research translation into practice since evidence takes 17 years on average to reach clinical practice Supported by literature creating Tealeaf-A given promising results was then supported by a DDCF FRCS award further substantiating the accelerated pursuit of Tealeaf-A Also Tealeaf-A care delivery would ideally include teachers and peers Due to resource limitations and prioritizing indicated over complementary care a teacher-led Tealeaf-A adaptation was prioritized A grant is pending to develop a peer component
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None