- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06275672
Implementing an Education- and Health System Task-shifting Approach for Child Mental Health Promotion in Uganda (TREAT)
TREAT INTERACT: Implementing a User Involved Education- and Health System Interactive Task-shifting Approach for Child Mental Health Promotion in Uganda
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ane-Marthe Solheim Skar, PhD
- Phone Number: +4797661591
- Email: a.m.s.skar@nkvts.no
Study Locations
-
-
-
Oslo, Norway, 0655
- Recruiting
- Nowegian Center for Violence and Traumatic Stress Studies
-
Contact:
- Ane-Marthe Skar, PhD
- Phone Number: 97661591
- Email: amskar@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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.
|
Active Comparator: Cohort 2
Same as arm 1
|
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.
|
Active Comparator: Cohort 3
Same as arms 1-2
|
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.
|
Active Comparator: Cohort 4
Same as arms 1-3
|
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.
|
Active Comparator: Cohort 5
Same as arms 1-4
|
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.
|
Active Comparator: Cohort 6
Same as arms 1-5
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reach questionnaire, developed by the project group
Time Frame: Through study completion, an average of 1.5 years
|
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)
Time Frame: Through study completion, an average of 1.5 years
|
For teachers. 22 items measuring the following:
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
Time Frame: Through study completion, an average of 1.5 years
|
For teachers. 21 items measuring the following dimention of Service Utilization will be created during the mapping process:
|
Through study completion, an average of 1.5 years
|
Attitudes about Child Mental Health (Perceived Discrimination-Devaluation (Link et al., 1987) questionnaire
Time Frame: Through study completion, an average of 1.5 years
|
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)
Time Frame: Through study completion, an average of 1.5 years
|
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")
Time Frame: Through study completion, an average of 1.5 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Implementation Quality Questionnaire (Bogen, 2020)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Fidelity Scale, developed by the project group
Time Frame: Through study completion, an average of 1.5 years
|
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
|
General Health Questionnaire (GHQ; Goldberg, 1970)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Attitudes on Gender Norms (Waszak et al., 2000) questionnaire
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Help-seeking behaviour, developed by the project group after inspiration from Yifeng et al., 2022
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Pediatric Symptom Checklist (PSC-17; Jellinek et al., 1998)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Teacher Support Scale (TSS; Metheny, McWhirter, & O'Neil, 2008)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Teacher violence scale (Piskin et al, 2014)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
The dimensions of discipline inventory, home (DDI; Strauss & Faucher, 2007)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
The Implementation Leadership Scale (Aarons, Ehrhart, et al., 2014)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Organizational Readiness for Implementing Change (Shea et al., 2014)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Teacher concerns about child mental health, developed by the project group, after inspiration from Yifeng et al., 2022
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Provider Report of Sustainment Scale (PRESS) (Moullin et al., 2021) (PRESS): development and validation (PRESS; Moullin et al., 2021)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Mental health knowledge (Evans-Lacko et al.,
Time Frame: Through study completion, an average of 1.5 years
|
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
|
AUDIT scale (WHO)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Child alcohol use, developed by the project group
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Child mental health - Pediatric symptoms (Jelinek et al.)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Perceived teacher support and its influence on adolescent career development (Metheny et al., 2008)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Sexual violence, developed by the project group
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Dimensions of discipline inventory (DDI; Straus and Fauchier, 2007)
Time Frame: Through study completion, an average of 1.5 years
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ane-Marthe Solheim Skar, Norwegian Center for Voilence and Traumatic Stress Studies
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TREAT INTERACT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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