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

NCT ID: NCT06275672

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Mental Health Issue Stigma, Social Child Development Child Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stepped-wedge cluster randomized trial to randomize 18 schools into six cohorts of three schools incrementally.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cohort 1

An Ugandan adapted version of the mhGAP-IG child and adolescent mental health module will be used for identification, assessment, and management of common mental disorders in children and adolescents at primary schools.

Group Type ACTIVE_COMPARATOR

Adapted version of the mhGAP-IG

Intervention Type OTHER

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.

Cohort 2

Same as arm 1

Group Type ACTIVE_COMPARATOR

Adapted version of the mhGAP-IG

Intervention Type OTHER

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.

Cohort 3

Same as arms 1-2

Group Type ACTIVE_COMPARATOR

Adapted version of the mhGAP-IG

Intervention Type OTHER

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.

Cohort 4

Same as arms 1-3

Group Type ACTIVE_COMPARATOR

Adapted version of the mhGAP-IG

Intervention Type OTHER

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.

Cohort 5

Same as arms 1-4

Group Type ACTIVE_COMPARATOR

Adapted version of the mhGAP-IG

Intervention Type OTHER

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.

Cohort 6

Same as arms 1-5

Group Type ACTIVE_COMPARATOR

Adapted version of the mhGAP-IG

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Makerere University

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

Norwegian Center for Violence and Traumatic Stress Studies

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ane-Marthe Solheim Skar

Role: PRINCIPAL_INVESTIGATOR

Norwegian Center for Voilence and Traumatic Stress Studies

Locations

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Nowegian Center for Violence and Traumatic Stress Studies

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Ane-Marthe Solheim Skar, PhD

Role: CONTACT

+4797661591

Facility Contacts

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Ane-Marthe Skar, PhD

Role: primary

References

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Skar AS, Engebretsen IMS, Braathu N, Aber H, Baekkelund H, Kuhl MJ, Mukisa M, Nalugya JS, Skokauskas N, Skylstad V, Wentzel-Larsen T; TREAT research consortium; Babirye JN. Study protocol for a stepped-wedge implementation study investigating the intersectoral collaboration of implementering the TREAT INTERACT intervention for primary school teachers and the mhGAP for health care workers for child mental health promotion in Uganda. Trials. 2024 Jul 9;25(1):465. doi: 10.1186/s13063-024-08312-5.

Reference Type DERIVED
PMID: 38982328 (View on PubMed)

Other Identifiers

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TREAT INTERACT

Identifier Type: -

Identifier Source: org_study_id

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