NCT06275672

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

December 28, 2023

Last Update Submit

February 16, 2024

Conditions

Keywords

AdolescentChildGlobal mental healthImplementationLow- and middle income countriesPrimary schoolsTask shiftingTeachersUganda

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (20)

  • The Implementation Quality Questionnaire (Bogen, 2020)

    Through study completion, an average of 1.5 years

  • Fidelity Scale, developed by the project group

    Through study completion, an average of 1.5 years

  • General Health Questionnaire (GHQ; Goldberg, 1970)

    Through study completion, an average of 1.5 years

  • Attitudes on Gender Norms (Waszak et al., 2000) questionnaire

    Through study completion, an average of 1.5 years

  • Help-seeking behaviour, developed by the project group after inspiration from Yifeng et al., 2022

    Through study completion, an average of 1.5 years

  • +15 more secondary outcomes

Study Arms (6)

Cohort 1

ACTIVE COMPARATOR

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.

Other: Adapted version of the mhGAP-IG

Cohort 2

ACTIVE COMPARATOR

Same as arm 1

Other: Adapted version of the mhGAP-IG

Cohort 3

ACTIVE COMPARATOR

Same as arms 1-2

Other: Adapted version of the mhGAP-IG

Cohort 4

ACTIVE COMPARATOR

Same as arms 1-3

Other: Adapted version of the mhGAP-IG

Cohort 5

ACTIVE COMPARATOR

Same as arms 1-4

Other: Adapted version of the mhGAP-IG

Cohort 6

ACTIVE COMPARATOR

Same as arms 1-5

Other: Adapted version of the mhGAP-IG

Interventions

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 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nowegian Center for Violence and Traumatic Stress Studies

Oslo, 0655, Norway

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Ane-Marthe Solheim Skar

    Norwegian Center for Voilence and Traumatic Stress Studies

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ane-Marthe Solheim Skar, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Stepped-wedge cluster randomized trial to randomize 18 schools into six cohorts of three schools incrementally.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2023

First Posted

February 23, 2024

Study Start

August 1, 2023

Primary Completion

May 1, 2025

Study Completion

December 1, 2025

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations