Promoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda

Not Applicable

Recruiting

• Conditions: Depression, Anxiety; Mental Health Literacy
• Interventions: Behavioral: mHealth Toolkit for Wellness & Empowering Lives of School Community (mWEL)

• Registration Number: NCT06087159
• Lead Sponsor: NYU Langone Health

Brief Summary

This is a randomized controlled trial with 8 schools (4 intervention and 4 wait-list control schools) including 160 caregivers (80 teachers and 80 parents), with the aim of pilot testing the implementation process, feasibility, acceptability, usage patterns, and efficacy of the mHealth Toolkit for Wellness \& Empowering Lives of School Community (mWEL) in Uganda. The mWEL-App 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 P-CHWs. The investigators hypothesize that: 1) relative to the control, caregivers receiving the mWEL will have better efficacy outcomes (mental health literacy, and mental health outcomes); and 2) mWEL implementation will have high acceptability, appropriateness, and feasibility.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-17
• Study Start: 2024-11-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-05-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• The inclusion criteria for teachers and parents for mWEL user center testing and feasibility data collection are: teachers who are teaching in recruited schools and are at least 18 years old. Parents who are at least 18 years old, and have a child aged 6-14 years will be eligible.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mWEL Intervention	mHealth Toolkit for Wellness & Empowering Lives of School Community (mWEL)	Teachers or parents of children in participating schools who are randomly assigned to receive the mWEL intervention.

Primary Outcome Measures

Name	Time	Method
Change in Universal Mental Health Literacy Scale Score	Baseline, Month 5	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
Change in PHQ-9 Score	Baseline, Month 5	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
Change in GAD-7 Anxiety Score	Baseline, Month 5	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

Trial Locations

Locations (1)

Study Site; 🇺🇬 Nakaseke, Uganda