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

Primary Purpose

Mental Health Literacy, Depression, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
mHealth Toolkit for Wellness & Empowering Lives of School Community (mWEL)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Health Literacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Study Site
  • Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mWEL Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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
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

Secondary Outcome Measures

Full Information

First Posted
October 11, 2023
Last Updated
October 11, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT06087159
Brief Title
Promoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda
Official Title
Promoting Mental Health of Teachers and Caregivers Using a Personalized mHealth Toolkit in Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2024 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Literacy, Depression, Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mWEL Intervention
Arm Type
Experimental
Arm Description
Teachers or parents of children in participating schools who are randomly assigned to receive the mWEL intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Teachers or parents of children in participating schools who are randomly assigned to the control arm.
Intervention Type
Behavioral
Intervention Name(s)
mHealth Toolkit for Wellness & Empowering Lives of School Community (mWEL)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Universal Mental Health Literacy Scale Score
Description
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.
Time Frame
Baseline, Month 5
Title
Change in Kessler Psychological Distress Scale (K10) Score
Description
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.
Time Frame
Baseline, Month 5
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
Description
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
Time Frame
Baseline, Month 5
Title
Change in PROMIS Anxiety Score
Description
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
Time Frame
Baseline, Month 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keng-Yen Huang, PhD, MPH
Phone
646-501-2879
Email
Keng-Yen.Huang@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Demy Kamboukos, Ph.D.
Phone
646-754-4987
Email
Demy.Kamboukos@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keng-Yen Huang, PhD, MPH
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Study Site
City
Kampala
Country
Uganda
Facility Name
Study Site
City
Nakaseke
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.

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

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