Mental Health Literacy and Mental Health Promotion With Urban Refugee Youth in Kampala, Uganda

Tushirikiane4MH: Mental Health Literacy and Mental Health Promotion With Urban Refugee Youth in Kampala, Uganda

From our previous studies, we know that urban refugee youth commonly report depressive symptoms. The primary aim of this study is to compare the effectiveness of youth-tailored interventions to improve mental health literacy and reduce mental health stigma among urban refugee youth in Kampala, Uganda. There will be two intervention arms and one control arm. The first intervention arm will involve a VR experience that focuses on mental health literacy and coping strategies, as well as SMS check-ins from peer navigators (PN) trained in psychological first aid. The second intervention arm will involve an adapted version of the WHO's Group Problem Management Plus. The primary outcomes are to a) increase mental health literacy (knowledge and understanding of mental health generally and of specific disorders; b) increase attitudes towards mental health help-seeking, c) reduce depression, d) increase adaptive coping strategies; e) reduce mental health stigma, f) improve mental wellbeing, and g) increase level of functioning. Participants will complete a pre- and post-intervention survey as well as a follow-up survey.

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: VR + MHL intervention; Behavioral: Group PM+

• Study Type: Interventional
• Enrollment (Anticipated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmen Logie, PhD; Phone Number: 6474544203; Email: carmen.logie@utoronto.ca
• Study Contact Backup: Name: Moses Okumu, PhD; Phone Number: 6476067832; Email: okumu@illinois.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. living in one of the 5 informal settlements in Kampala we already work with (Nsambya, Katwe, Rubaga, Kabalagala, Kansanga);
2. self identify as a woman or man (transgender inclusive);
3. identify as a refugee/displaced person/having refugee parents;
4. aged 16-25;
5. own a mobile phone;
6. speak Swahili, Luganda, Kirundi, Kinyarwanda, French or English and can provide informed consent.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality and mental health literacy intervention; This arm will participate in an interactive virtual reality experience to learn and practice mental health literacy and psychological first aid skills, supplemented by mhealth SMS with informational bidirectional messages.	Behavioral: VR + MHL intervention; The intervention will include: 1) a Virtual Reality (VR) interactive and immersive 30-minute session viewed using a low cost VR headset; and 2) an 8-week program of weekly WelTel SMS check-ins managed by Peer Navigators (PNs), weekly WelTel SMS blasts informed by Psychological First Aid (PFA) with mental health literacy (MHL) messages developed with PN, and weekly WelTel web-based secure platform social group discussions on MHL, stress coping, and stigma moderated by PN alongside a trained Coordinator. Weekly MHL WelTel platform moderated discussion foci will address MHL, stigma and stress coping strategies, including self-compassion and other strategies that emerge from the urban refugee youth interviews and focus groups, through diverse methods, including: 'scenarios' mimicking real life situations; a 'question box'; sharing photos demonstrating stress coping strategies; memes; songs; and ways participants interrupted stigma in their daily lives.
Experimental: Group Problem Management+ and VR/mental health literacy; This arm will participate in an interactive virtual reality experience to learn and practice mental health literacy and psychological first aid skills, supplemented by mhealth SMS with informational bidirectional messages. This arm will also participate in an 5-week Group Problem Management Plus intervention, a group based problem solving intervention.	Behavioral: Group PM+; Participants will attend small groups (5-6 participants with a PN and a coordinator supporting) outdoors with physically distancing, for Group PM+ sessions following the adapted WHO Group-PM+ manual (adaptations made in Phase 1 explain above) 5 weekly 3-hour sessions delivered by PN who will co-facilitate sessions with the Coordinator. Each session has a mechanism of action: Managing stress: mechanism of action-identify goals, learn deep breathing and techniques for stress management; Managing problems: mechanism of action-identify 1 solvable practical problem, brainstorm possible solutions together; Get going, keep doing: mechanism of action-learn about depression and inactivity, identify and plan small enjoyable activities; Strengthen social support: mechanism of action-discuss a range of social support resources, make plan to increase social support; Staying well: mechanism of action- this session reviews all of the mechanisms of action in the prior 4 sessions
No Intervention: Control; This is a waitlist control. After Arms 1 and 2 are complete, the waitlist will receive the Group Problem Management Plus 5 week intervention on its own.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental health literacy	Measured using a modified depression literacy scale validated in Low- and Middle- Income Countries (LMICs)	change from baseline at 16 weeks
Attitudes towards mental health help seeking	Measured using the Inventory of Attitudes towards Seeking Mental Health Services	change from baseline at 16 weeks
Depression	Measured using the PHQ-9	change from baseline at 16 weeks
Adaptive coping strategies	Measured by the Kidcope and Self-Compassion Scale for Youth	change from baseline at 16 weeks
Mental Health Stigma	Measured using the Brief Version of the Internalized Stigma of Mental Illness (ISMI) Scale	change from baseline at 16 weeks
Mental wellbeing	Measured using the WHO-Five Wellbeing Scale	change from baseline at 16 weeks
Level of functioning	Measured usingWHO Disability Assessment Schedule	change from baseline at 16 weeks

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: Young African Refugees for Integral Development
• Investigators: Principal Investigator: Carmen Logie, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Anticipated): January 31, 2022
• Primary Completion (Anticipated): May 27, 2022
• Study Completion (Anticipated): May 27, 2022

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 40965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The final deidentified data set will be available to users who enter a data-sharing agreement with us. Users will need to (1) secure ethics approval from both their institution and the University of Toronto research ethics board; (2) commit to use the data solely for research purposes, and not to identify any individual participant; (3) commit to securing the data using the appropriate computer technology such as encryption; and (4) commit to destroying or returning the data after analyses are complete.
• IPD Sharing Time Frame: Data will become available 12 months after study completion.
• IPD Sharing Access Criteria: The final deidentified data set will be available to users who enter a data-sharing agreement with us. Users will need to (1) secure ethics approval from both their institution and the University of Toronto research ethics board; (2) commit to use the data solely for research purposes, and not to identify any individual participant; (3) commit to securing the data using the appropriate computer technology such as encryption; and (4) commit to destroying or returning the data after analyses are complete.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No