Promoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda
1 other identifier
interventional
1,180
1 country
2
Brief Summary
This study record describes a two-phase of clinical trial study. The first phase is a pilot study phase (to study feasibility and efficacy of the intervention), and the second phase is an effectiveness study phase (a fully powered evaluation study to test the intervention effectiveness). This proposal seeks to develop and test a new mHealth intervention, the mHealth Toolkit for Wellness \& Empowering Lives of School Community (mWEL) in Uganda. The mWEL-digial toolkit is a preventive intervention tool for teachers and parents as a self-help support modality. Caregivers who need support in navigating the toolkit will be supported by peer-community health workers (P-CHWs).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2024
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2023
CompletedFirst Posted
Study publicly available on registry
October 17, 2023
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
April 20, 2026
April 1, 2026
2.7 years
October 11, 2023
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Change in Universal Mental Health Literacy Scale Score
The Universal Mental Health Literacy Scale comprises 21 items asking respondents to indicate their knowledge of various aspects regarding mental health. Items are rated on Yes/No or 5-point Likert scales. The total score is produced by mean of all item scores and ranges from 1-5 or % correct knowledge; higher scores indicate greater mental health literacy
Baseline, Month 5
Change in PHQ-9 Score
The Patient Health Questionnaire-9 (PHQ-9) is a widely used self-administered tool designed to screen, diagnose, and monitor the severity of depression in individuals. It consists of nine questions that align directly with the diagnostic criteria for major depressive disorder in the DSM-5. Each item asks about the frequency of specific depressive symptoms experienced over the past two weeks (on a 0 to 3 point Likert scales), such as low mood, loss of interest, sleep problems, fatigue, appetite changes, feelings of worthlessness, trouble concentrating, psychomotor changes, and thoughts of self-harm or suicide. The total score ranges from 0 to 27, with higher scores indicating more severe depression. Severity is typically interpreted as follows: 0-4: None to minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression
Baseline, Month 5
Change in GAD-7 Anxiety Score
The Generalized Anxiety Disorder 7-item scale (GAD-7) is a brief, self-administered questionnaire designed to screen for and assess the severity of generalized anxiety disorder (GAD) symptoms over the past two weeks. The scale is rated on a 0 to 3 point Likert scales). The total GAD-7 score ranges from 0 to 21, with higher scores indicating greater anxiety severity. Severity is commonly interpreted as: 0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety Less than 55 = None to slight depression 55.0-59.9 = Mild depression 60.0-69.9 = Moderate depression 70 and over = Severe depression
Baseline, Month 5
Study Arms (2)
mWEL Intervention (Phase 1 and Phase 2)
EXPERIMENTALTeachers or parents of children in participating schools who are randomly assigned to receive the mWEL intervention.
Control (Phase 1 and Phase 2)
NO INTERVENTIONTeachers or parents of children in participating schools who are randomly assigned to the control arm.
Interventions
mWEL-App is a preventive intervention tool for teachers and parents as a self-help support. It integrates three key mental health presentive service functions: i) comprehensive screen to assess mental health (anxiety, depression), stress, and related contextual risks; ii) a tailored strength and weakness profile/report with recommendations to promote self-awareness and mental health knowledge; and iii) tailored evidence-based strategies and additional support and clinical resources to improve skills in stress management, emotion regulation, and maintain mental wellness. mWEL will be designed as a self-administered tool. Participating parents and teachers can access to mWEL app after they sign up for an account. Intervention participants will have access to the App anytime within a 3-5 month study period.
Eligibility Criteria
You may qualify if:
- Teaching in recruited schools.
- At least 18 years old.
- At least 18 years old.
- Have a child aged 6-14 years.
You may not qualify if:
- Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study.
- Parents/Teachers/Caregivers who are not in one of our recruited primary school
- Participants under the age of 18
- Participant who does not speak English and Luganda will not be able to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (2)
Study Site
Kampala, Uganda
Study Site
Nakaseke, Uganda
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keng-Yen Huang, PhD, MPH
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2023
First Posted
October 17, 2023
Study Start
November 1, 2024
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
January 31, 2028
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Keng-Yen.Huang@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Keng-Yen.Huang@nyulangone.org The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.