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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06087159
• Other study ID #: 23-00600
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: Keng-Yen Huang, PhD, MPH
• Phone: 646-501-2879
• Email: Keng-Yen.Huang[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: July 30, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Mental Health Literacy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Uganda	Study Site	Kampala
Uganda	Study Site	Nakaseke

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Universal Mental Health Literacy Scale Score	The Universal Mental Health Literacy Scale comprises 35 items asking respondents to indicate their knowledge of various aspects regarding mental health. Items are rated on 4 or 5-point Likert scales. The total score is produced by summing all item scores and ranges from 35 to 160; higher scores indicate greater mental health literacy.	Baseline, Month 5
Primary	Change in Kessler Psychological Distress Scale (K10) Score	The K10 scale involves 10 questions about emotional states. Each item is scored from 1 'none of the time' to 5 'all of the time'. The total score is the sum of responses, with a minimum score of 10 and a maximum score of 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress.	Baseline, Month 5
Primary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score	8-item assessment of depressive symptoms over the past 7 days. Each item is rated on a scale from 1 (never) to 5 (always). The raw score is the sum of responses with a range in score from 8 to 40 with higher scores indicating greater severity of depression. The raw score is transformed into a T-score, where values are interpreted as follows: 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
Primary	Change in PROMIS Anxiety Score	7-item assessment of anxiety symptoms over the past 7 days. Each item is rated on a scale from 1 (never) to 5 (always). The raw score is the sum of responses with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. The raw score is transformed into a T-score, where values are interpreted as follows: Less than 55 = None to slight anxiety 55.0-59.9 = Mild anxiety 60.0-69.9 = Moderate anxiety 70 and over = Severe anxiety	Baseline, Month 5