Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275672
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2023-12-28
Brief Title:
Implementing an Education- and Health System Task-shifting Approach for Child Mental Health Promotion in Uganda
Sponsor:
Norwegian Center for Violence and Traumatic Stress Studies
Organization:
Norwegian Center for Violence and Traumatic Stress Studies
Study Overview
Official Title:
TREAT INTERACT Implementing a User Involved Education- and Health System Interactive Task-shifting Approach for Child Mental Health Promotion in Uganda
Status:
RECRUITING
Status Verified Date:
2024-02
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:
TREAT
Brief Summary:
This study will adapt a school version mhGAP-IGs of the World Health Organizations WHO Mental Health Gap Action Programme Intervention Guide mhGAP Both teachers and health workers will receive training in mhGAP and systems for collaboration between the school and health sector as well as other relevant stakeholders will be developed and integrated The project is conducted in close collaboration with key stakeholders from the Ministry the health and education sector the police and religious leaders The aim is to increase mental health literacy among school staff facilitate a healthy school environment and increase detection of mental health needs among primary school aged children
Detailed Description:
Background Mental and neuropsychological disorders make up approximately 14 percent of the total health burden globally with 80 of the affected living in low- and middle-income countries LMICs In these countries more than 90 of children cannot access mental health services therefore service strengthening is warranted The main objective of the TREAT INTERACT study is to adapt implement and evaluate the impact of a novel intersectoral treatment interactive approach to prevent identify refer and treat mental health problems in children and adolescents through a user centered task-shifting adaptation and implementation of the World Health Organization WHO Mental Health Gap Action Programme mhGAP Intervention Guide mhGAP-IG for primary school staff in Mbale Eastern Uganda In this study the aims are to 1 Adapt the mhGAP-IG to primary school settings 2 Implement the adapted module-based school program and investigate effective implementation strategies and teacher student and caregiver outcomes 3 Develop implement and evaluate an intersectoral supervision referral and communication model between the health and education sectors and 4 Develop sustainable and scalable implementation advice and guidelines with policymakers
Methods This project is a pragmatic mixed-methods hybrid Type II Implementation-Effectiveness study utilizing a co-design approach The main study will utilize a stepped-wedged design with phased implementation where participating schools will be randomized to intervention initiation Those not yet randomized to the intervention will serve as controls There will be six starting sequences and three schools will be randomized to intervention initiation at each randomization interval In addition other quantitative designs including a nested prospective cohort case control studies cross-sectional studies in addition to qualitative research will strengthen the necessary components for successful implementation and evaluation
Population Teachers are the primary participants in the trial In addition data will be collected from health personnel school leadership pupils and their caregivers
Outcomes Implementation outcomes include detection reach sustainability and service delivery to children and adolescents in need of the mhGAP from the school and health sectors Main client outcomes include teachers mental health literacy stigma and violence towards the school children Child and caregiver outcomes will include mental health status mental health literacy and help-seeking behavior
Discussion This study will provide knowledge on implementation and sustainability of mental health programs relevant for children in primary schools in line with current WHO guidelines
Methods This project is a pragmatic mixed-methods hybrid Type II Implementation-Effectiveness study utilizing a co-design approach The main study will utilize a stepped-wedged design with phased implementation where participating schools will be randomized to intervention initiation Those not yet randomized to the intervention will serve as controls There will be six starting sequences and three schools will be randomized to intervention initiation at each randomization interval In addition other quantitative designs including a nested prospective cohort case control studies cross-sectional studies in addition to qualitative research will strengthen the necessary components for successful implementation and evaluation
Population Teachers are the primary participants in the trial In addition data will be collected from health personnel school leadership pupils and their caregivers
Outcomes Implementation outcomes include detection reach sustainability and service delivery to children and adolescents in need of the mhGAP from the school and health sectors Main client outcomes include teachers mental health literacy stigma and violence towards the school children Child and caregiver outcomes will include mental health status mental health literacy and help-seeking behavior
Discussion This study will provide knowledge on implementation and sustainability of mental health programs relevant for children in primary schools in line with current WHO guidelines
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