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Mental Health IssueTREATNCT06275672

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

A study testing Adapted version of the mhGAP-IG in people with Mental Health Issue and Stigma, Social, run by Norwegian Center for Violence and Traumatic Stress Studies at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 5 to 18 years
What is being tested?
Adapted version of the mhGAP-IG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteNorway
Study dates
1 Aug 2023to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Ane-Marthe Solheim Skar, PhD contact

+4797661591

a.m.s.skar@nkvts.no

Norway1 site, 1 recruiting

  • Nowegian Center for Violence and Traumatic Stress Studies

    Oslo, 0655

    Ane-Marthe Skar, PhD, 97661591, amskar@gmail.com

    Recruiting

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
Adapted version of the mhGAP-IG
Keywords
Adolescent, Child, Global mental health, Implementation, Low- and middle income countries, Primary schools, Task shifting, Teachers, Uganda
Medical subject headings
Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted version of the mhGAP-IGOther

    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.

Study groups in NCT06275672
Study groupRoleWhat they receive
Cohort 1Active comparatorAn 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.
Receives: Other: Adapted version of the mhGAP-IG
Cohort 2Active comparatorSame as arm 1
Receives: Other: Adapted version of the mhGAP-IG
Cohort 3Active comparatorSame as arms 1-2
Receives: Other: Adapted version of the mhGAP-IG
Cohort 4Active comparatorSame as arms 1-3
Receives: Other: Adapted version of the mhGAP-IG
Cohort 5Active comparatorSame as arms 1-4
Receives: Other: Adapted version of the mhGAP-IG
Cohort 6Active comparatorSame as arms 1-5
Receives: Other: Adapted version of the mhGAP-IG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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?")

    Measured: Through study completion, an average of 1.5 years

  2. 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)

    Measured: Through study completion, an average of 1.5 years

  3. 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)

    Measured: Through study completion, an average of 1.5 years

  4. 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)

    Measured: Through study completion, an average of 1.5 years

  5. 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)

    Measured: Through study completion, an average of 1.5 years

  6. 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.

    Measured: Through study completion, an average of 1.5 years

Secondary outcomes (20)

  1. 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)

    Measured: Through study completion, an average of 1.5 years

  2. 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.

    Measured: Through study completion, an average of 1.5 years

  3. 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)

    Measured: Through study completion, an average of 1.5 years

  4. 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)

    Measured: Through study completion, an average of 1.5 years

  5. 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).

    Measured: Through study completion, an average of 1.5 years

  6. 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)

    Measured: Through study completion, an average of 1.5 years

  7. 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)

    Measured: Through study completion, an average of 1.5 years

  8. 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)

    Measured: Through study completion, an average of 1.5 years

  9. 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)

    Measured: Through study completion, an average of 1.5 years

  10. 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)

    Measured: Through study completion, an average of 1.5 years

  11. 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)

    Measured: Through study completion, an average of 1.5 years

  12. 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)

    Measured: Through study completion, an average of 1.5 years

  13. 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)

    Measured: Through study completion, an average of 1.5 years

  14. 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)

    Measured: Through study completion, an average of 1.5 years

  15. 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.

    Measured: Through study completion, an average of 1.5 years

  16. 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).

    Measured: Through study completion, an average of 1.5 years

  17. 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)

    Measured: Through study completion, an average of 1.5 years

  18. 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)

    Measured: Through study completion, an average of 1.5 years

  19. 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)

    Measured: Through study completion, an average of 1.5 years

  20. 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)

    Measured: Through study completion, an average of 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start1 Aug 2023
  3. Primary completionMay 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Model description
Stepped-wedge cluster randomized trial to randomize 18 schools into six cohorts of three schools incrementally.
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06275672
Sponsor's protocol ID
TREAT INTERACT
Acronym
TREAT
Status last verified
Feb 2024
First submitted
28 Dec 2023
Last updated
23 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38982328

Questions about this trial

What is this clinical trial studying?

A study testing Adapted version of the mhGAP-IG in people with Mental Health Issue and Stigma, Social, run by Norwegian Center for Violence and Traumatic Stress Studies at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ane-Marthe Solheim Skar, PhD (+4797661591, a.m.s.skar@nkvts.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reach questionnaire, developed by the project group (time frame: Through study completion, an average of 1.5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06275672, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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