Implementing an Education- and Health System Task-shifting Approach for Child Mental Health Promotion in Uganda

Child Development Clinical Trial

— TREAT  

Official title:

TREAT INTERACT: Implementing a User Involved Education- and Health System Interactive Task-shifting Approach for Child Mental Health Promotion in Uganda

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06275672
• Other study ID #: TREAT INTERACT
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Norwegian Center for Violence and Traumatic Stress Studies
• Contact: Ane-Marthe Solheim Skar, PhD
• Phone: +4797661591
• Email: a.m.s.skar[@]nkvts.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Abuse
• Child Development
• Mental Health Issue
• Stigma, Social

Intervention

Other:
• Adapted version of the mhGAP-IG
An Ugandan adapted version of the mhGAP-IG CAMH module for identification, assessment, and management of common mental disorders in children and adolescents. The mhGAP-IG CAMH module further details six different protocols for the management of these mental health problems, primarily based on psychosocial and systemic interventions. The described psychosocial interventions can also be provided as general prevention for children with subclinical problems. Lastly, the module guides further follow-up assessment. Experts identified by the Ministry of Health will train trainers who train and follow-up teachers and health personnel receiving the intervention.

Locations

Country	Name	City	State
Norway	Nowegian Center for Violence and Traumatic Stress Studies	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian Center for Violence and Traumatic Stress Studies	Makerere University, Norwegian Institute of Public Health, Norwegian University of Science and Technology, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach questionnaire, developed by the project group	For teachers. Proportion of children reached by the program. Consist of one question: "Have you ever referred a child at school to the health system?" If no (scored 0), no further questions are asked. If yes (scored 1), an additional 5 questions follows (e.g., "If yes, have any of these referrals to the health system been because of a mental health problem?")	Through study completion, an average of 1.5 years
Primary	The Program Sustainability tool (Finch et al., 2013)	For teachers. 22 items measuring the following: Financial stability; Organizational Support; Staff Retention: Program Integration; Stakeholder Perceptions; Program Outcomes and Impact; It is scored from 0 (little to no extent) to 7 (to a very great extent). A summed score is created (a minimum score of 0 and a maximum score of 154, where a higher score mean a better outcome)	Through study completion, an average of 1.5 years
Primary	Service measure on access to mental health care, developed by the project group	For teachers. 21 items measuring the following dimention of Service Utilization will be created during the mapping process: Wait Times; Geographical Accessibility; Affordability; Equity and Disparities; Satisfaction and Perceived Access; Referral Patterns; Availability of Services Scored 0 (never) to 4 (at least once a year). A summed score is created (a minimum score of 0 and a maximum score of 105, where a higher score mean a better outcome)	Through study completion, an average of 1.5 years
Primary	Attitudes about Child Mental Health (Perceived Discrimination-Devaluation (Link et al., 1987) questionnaire	For teachers. 10 items measuring stigma and mental health literacy.; Scored from 1 (strongly disagree) to 7 (strongly agree). A summed score is created (a minimum score of 0 and a maximum score of 70, where a higher score mean a better outcome)	Through study completion, an average of 1.5 years
Primary	The dimensions of discipline inventory, school (DDI; Strauss & Faucher, 2007)	For children. 11 items measuring incidents of teacher violence. Scored from 0 (never) to 4 (at least once a year). A summed score is created (a minimum score of 0 and a maximum score of 44, where a higher score mean a worse outcome)	Through study completion, an average of 1.5 years
Primary	Treatment at home, developed by the project group, by inspiration from our siste project "TREAT C-AUD")	For children. 10 items measuring treatment at home. Scoring instructions will be deveoped during the mapping process.	Through study completion, an average of 1.5 years
Secondary	The Implementation Quality Questionnaire (Bogen, 2020)	For teachers and school staff. 26 questions on the perception of acceptability, appropriateness, feasibility, ownership, school climate and user participation. Scored from 1 (strongly disagree) to 7 (strongtly agree). A summed score is created, as well as a score for each dimention (a minimum score of 0 and a maximum score of 182, where a higher score mean a better outcome)	Through study completion, an average of 1.5 years
Secondary	Fidelity Scale, developed by the project group	For teachers. A scale to measure the fidelity to the intervention, including adaptations and modifications will be developed as part of the mapping process.	Through study completion, an average of 1.5 years
Secondary	General Health Questionnaire (GHQ; Goldberg, 1970)	For teachers. 12 items measuring personal mental health, scored 1 (better than usual) to 4 (much less than usual). A summed score is created (a minimum score of 0 and a maximum score of 48, where a higher score mean a worse outcome)	Through study completion, an average of 1.5 years
Secondary	Attitudes on Gender Norms (Waszak et al., 2000) questionnaire	For teachers and caregivers. 10 items measuring tteacher reported gender norms. Scored 0 (disagree) or 1 (agree). A summed score is created (a minimum score of 0 and a maximum score of 10, where a higher score mean a better outcome)	Through study completion, an average of 1.5 years
Secondary	Help-seeking behaviour, developed by the project group after inspiration from Yifeng et al., 2022	For caregivers. Help seeking behaviour is measured by the following question: At any point during the past 3 months, did you ever speak to a health professional about any mental health problem or concern? Scored from 1 ( did not have any mental health problem or concern) to 4 (I decided not to speak to a health professional although I am concerned about my mental health).	Through study completion, an average of 1.5 years
Secondary	Pediatric Symptom Checklist (PSC-17; Jellinek et al., 1998)	For children. 17 items measuring child mental health. Scored 0 (never) to 2 (often). A summed score is created(a minimum score of 0 and a maximum score of 34, where a higher score mean a worse outcome)	Through study completion, an average of 1.5 years
Secondary	Teacher Support Scale (TSS; Metheny, McWhirter, & O'Neil, 2008)	For children. 21 items measuring child-reported support from teachers. Scored from 1 (disagree) to 3 (agree). A summed score is created (a minimum score of 21 and a maximum score of 63, where a higher score mean a better outcome)	Through study completion, an average of 1.5 years
Secondary	Teacher violence scale (Piskin et al, 2014)	For children. 29 items on teacher violence. Scored from 0 (never) to 5 (every day) (a minimum score of 0 and a maximum score of 145, where a higher score mean a worse outcome)	Through study completion, an average of 1.5 years
Secondary	The dimensions of discipline inventory, home (DDI; Strauss & Faucher, 2007)	For children. 7 items measuring discipline at home. Scored from 0 (never) to 4 (at least once a year) (a minimum score of 0 and a maximum score of 28, where a higher score mean a worse outcome)	Through study completion, an average of 1.5 years
Secondary	The Implementation Leadership Scale (Aarons, Ehrhart, et al., 2014)	For teachers. 12 items measuring the following subscales: Proactive, knowledgeable, supportive, perservant, and available. Scored 0 (not at al) to 4 (to a very great extent). A summed score is created (a minimum score of 0 and a maximum score of 48, where a higher score mean a better outcome)	Through study completion, an average of 1.5 years
Secondary	Organizational Readiness for Implementing Change (Shea et al., 2014)	For teachers and scool staff. 12 items measuring change efficacy. Scored from 1 (strongly disagree) to 5 (strongly agree). A summed score is created (a minimum score of 12 and a maximum score of 60, where a higher score mean a better outcome)	Through study completion, an average of 1.5 years
Secondary	Teacher concerns about child mental health, developed by the project group, after inspiration from Yifeng et al., 2022	For teachers. 7 items measuring concerns, referrals, and support. Each question is scored individually (both yes/no, number response, and qualitative resonse)	Through study completion, an average of 1.5 years
Secondary	Provider Report of Sustainment Scale (PRESS) (Moullin et al., 2021) (PRESS): development and validation (PRESS; Moullin et al., 2021)	For teachers. 3 items measuring if staff use the intervention. Scored from 0 (not al all) to 4 (to a very great extent). A summed score is created (a minimum score of 0 and a maximum score of 12, where a higher score mean a better outcome)	Through study completion, an average of 1.5 years
Secondary	Mental health knowledge (Evans-Lacko et al.,	For caregivers. 17 items measuring caregiver mental health literacy. Scored from 1 (disagree strongly) to 6 (agree strongly). A summed score is created (a minimum score of 17 and a maximum score of 102, where a higher score mean a better outcome)	Through study completion, an average of 1.5 years
Secondary	AUDIT scale (WHO)	For caregivers. 11 items measuring alcohol use by caregivers. Scoring will be decided in accordance to the RQ later in the mapping process.	Through study completion, an average of 1.5 years
Secondary	Child alcohol use, developed by the project group	For children. 5 items measuring child alcohol use (e.g., Have you ever had a drink of alcohol rather than a few sips?). Scored individually (numeric or yes/no).	Through study completion, an average of 1.5 years
Secondary	Child mental health - Pediatric symptoms (Jelinek et al.)	For children. 17 self-report questions on child mental health. Scored from 0 (never) to 2 (often). A summed score is created (a minimum score of 0 and a maximum score of 34, where a higher score mean a worse outcome)	Through study completion, an average of 1.5 years
Secondary	Perceived teacher support and its influence on adolescent career development (Metheny et al., 2008)	For children. 21 items scored from 1 (disagree) to 3 (agree). A summed score is created (a minimum score of 21 and a maximum score of 63, where a higher score mean a better outcome)	Through study completion, an average of 1.5 years
Secondary	Sexual violence, developed by the project group	For children. 9 items on experiences of sexual violece. Scored from 0 (no) to 3 (every term). A summed score is created (a minimum score of 0 and a maximum score of 27, where a higher score mean a worse outcome)	Through study completion, an average of 1.5 years
Secondary	Dimensions of discipline inventory (DDI; Straus and Fauchier, 2007)	For children. 7 items measuring corporal punishment. Scored from 0 (never) to 4 (at least once a year). A summed score is calculated (a minimum score of 0 and a maximum score of 28, where a higher score mean a worse outcome)	Through study completion, an average of 1.5 years