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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2028-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Adolescent Digital Mental Health-Kenya Effectiveness

NCT06403813

Mental Disorder in Adolescence

RECRUITING NA

Couples' Affect in Relationships Study

NCT06907654

Depression Disorders

NOT_YET_RECRUITING NA

Well-being in Students and Teachers Study

NCT06203288

Prosocial Behavior Community Sense Optimism +7 more

ACTIVE_NOT_RECRUITING NA

Longitudinal Well-Being Study

NCT06668532

Healthy

NOT_YET_RECRUITING NA

The Effectiveness of Engagement-based Personalization of a Digital Mental Health Intervention

NCT05300906

Well-being

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

During the first phase (from 11-01-2024 to 8-15-2025), a cluster randomized controlled trial (cRCT) with 8 schools (4 intervention and 4 wait-list control schools) including 160 caregivers (80 teachers and 80 parents) is conducted. The aim of the pilot RCT is to pilot test the implementation process, feasibility, acceptability, usage patterns, and efficacy of the mWEL. 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.

During the second phase (from 10-01-2025 to 08-31-2028), the optimized version of mWEL toolkit will be further tested for effectiveness using a cRCT and a matched-pair randomization method. The sample will be recruited from urban and rural schools. In intervention schools, participants will engage with the mWEL toolkit through group sessions or one-on-one support with Peer-Community Health Workers (P-CHWs). Control schools will receive general and non-mental health related health literacy information, and without any tailored support. Impacts on caregivers' health literacy and their mental health (anxiety, depression) will be evaluated (n=1000, 500 parents and 500 teachers in 24 schools, with 12 intervention and 12 wait-list control). The investigators hypothesize that: 1) relative to control, teachers and parents receiving mWEL will have better effectiveness outcomes (i.e., mental health literacy, and mental health outcomes; and 2) similar effectiveness findings for urban/rural schools and for male/female.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Health Literacy Depression, Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

mWEL Intervention (Phase 1 and Phase 2)

Teachers or parents of children in participating schools who are randomly assigned to receive the mWEL intervention.

Group Type EXPERIMENTAL

mHealth Toolkit for Wellness & Empowering Lives of School Community (mWEL)

Intervention Type BEHAVIORAL

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.

Control (Phase 1 and Phase 2)

Teachers or parents of children in participating schools who are randomly assigned to the control arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mHealth Toolkit for Wellness & Empowering Lives of School Community (mWEL)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Teaching in recruited schools.
* At least 18 years old.

* At least 18 years old.
* Have a child aged 6-14 years.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes