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Promoting Mental Health of Teachers and Caregivers Using a Personalized mHealth Toolkit in Uganda
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).
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Study Site
Kampala, Uganda
Study Site
Nakaseke, Uganda
Start Date
November 1, 2024
Primary Completion Date
August 1, 2027
Completion Date
January 31, 2028
Last Updated
December 15, 2025
1,180
ESTIMATED participants
mHealth Toolkit for Wellness & Empowering Lives of School Community (mWEL)
BEHAVIORAL
Lead Sponsor
NYU Langone Health
Collaborators
NCT05837104
NCT06178328
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06910748