Clinical trial NCT06275672: Implementing an Education- and Health System Task-shifting Approach for Child Mental Health Promotion in Uganda
Official title: TREAT INTERACT: Implementing a User Involved Education- and Health System Interactive Task-shifting Approach for Child Mental Health Promotion in Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Stigma, Social
Child Development
Child Abuse
Keywords: Adolescent
Child
Global mental health
Implementation
Low- and middle income countries
Primary schools
Task shifting
Teachers
Uganda
Lead sponsor: Norwegian Center for Violence and Traumatic Stress Studies
Sponsor class: OTHER
Collaborators: name: Makerere University
name: University of Bergen
name: Norwegian Institute of Public Health
name: Norwegian University of Science and Technology
First posted: 2024-02-23
Enrollment: 180
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge cluster randomized trial to randomize 18 schools into six cohorts of three schools incrementally.
Primary purpose: PREVENTION

Brief summary: This study will adapt a school version (mhGAP-IGs) of the World Health Organization´s (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.

Eligibility criteria: Inclusion Criteria:

* A teacher/ staff member at a preselected TREAT INTERACT primary school in Mbale.
* Child-caregiver pairs are eligible when a learner is enrolled in a selected primary school in Mbale, the child has a caregiver living with him or her and provides ascent, and the caregiver with a child in the selected school providing informed consent.

Exclusion Criteria:

* Not part of preselected primary school
* Lack of informed consent

Primary outcomes:
measure: Reach questionnaire, developed by the project group
timeFrame: Through study completion, an average of 1.5 years
measure: The Program Sustainability tool (Finch et al., 2013)
timeFrame: Through study completion, an average of 1.5 years
measure: Service measure on access to mental health care, developed by the project group
timeFrame: Through study completion, an average of 1.5 years
measure: Attitudes about Child Mental Health (Perceived Discrimination-Devaluation (Link et al., 1987) questionnaire
timeFrame: Through study completion, an average of 1.5 years
measure: The dimensions of discipline inventory, school (DDI; Strauss & Faucher, 2007)
timeFrame: Through study completion, an average of 1.5 years
measure: Treatment at home, developed by the project group, by inspiration from our siste project "TREAT C-AUD")
timeFrame: Through study completion, an average of 1.5 years
Secondary outcomes:
measure: The Implementation Quality Questionnaire (Bogen, 2020)
timeFrame: Through study completion, an average of 1.5 years
measure: Fidelity Scale, developed by the project group
timeFrame: Through study completion, an average of 1.5 years
measure: General Health Questionnaire (GHQ; Goldberg, 1970)
timeFrame: Through study completion, an average of 1.5 years
measure: Attitudes on Gender Norms (Waszak et al., 2000) questionnaire
timeFrame: Through study completion, an average of 1.5 years
measure: Help-seeking behaviour, developed by the project group after inspiration from Yifeng et al., 2022
timeFrame: Through study completion, an average of 1.5 years
measure: Pediatric Symptom Checklist (PSC-17; Jellinek et al., 1998)
timeFrame: Through study completion, an average of 1.5 years
measure: Teacher Support Scale (TSS; Metheny, McWhirter, & O'Neil, 2008)
timeFrame: Through study completion, an average of 1.5 years
measure: Teacher violence scale (Piskin et al, 2014)
timeFrame: Through study completion, an average of 1.5 years
measure: The dimensions of discipline inventory, home (DDI; Strauss & Faucher, 2007)
timeFrame: Through study completion, an average of 1.5 years
measure: The Implementation Leadership Scale (Aarons, Ehrhart, et al., 2014)
timeFrame: Through study completion, an average of 1.5 years
measure: Organizational Readiness for Implementing Change (Shea et al., 2014)
timeFrame: Through study completion, an average of 1.5 years
measure: Teacher concerns about child mental health, developed by the project group, after inspiration from Yifeng et al., 2022
timeFrame: Through study completion, an average of 1.5 years
measure: Provider Report of Sustainment Scale (PRESS) (Moullin et al., 2021) (PRESS): development and validation (PRESS; Moullin et al., 2021)
timeFrame: Through study completion, an average of 1.5 years
measure: Mental health knowledge (Evans-Lacko et al.,
timeFrame: Through study completion, an average of 1.5 years
measure: AUDIT scale (WHO)
timeFrame: Through study completion, an average of 1.5 years
measure: Child alcohol use, developed by the project group
timeFrame: Through study completion, an average of 1.5 years
measure: Child mental health - Pediatric symptoms (Jelinek et al.)
timeFrame: Through study completion, an average of 1.5 years
measure: Perceived teacher support and its influence on adolescent career development (Metheny et al., 2008)
timeFrame: Through study completion, an average of 1.5 years
measure: Sexual violence, developed by the project group
timeFrame: Through study completion, an average of 1.5 years
measure: Dimensions of discipline inventory (DDI; Straus and Fauchier, 2007)
timeFrame: Through study completion, an average of 1.5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Nowegian Center for Violence and Traumatic Stress Studies
Study officials:
affiliation: Norwegian Center for Voilence and Traumatic Stress Studies
name: Ane-Marthe Solheim Skar
role: PRINCIPAL_INVESTIGATOR
References: