NCT05187689

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2022

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

December 23, 2021

Last Update Submit

January 10, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (3)

Virtual reality and mental health literacy intervention

EXPERIMENTAL

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

Group Problem Management+ and VR/mental health literacy

EXPERIMENTAL

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+

Control

NO INTERVENTION

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.

Interventions

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.

Virtual reality and mental health literacy intervention
Group PM+BEHAVIORAL

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: 1. Managing stress: mechanism of action-identify goals, learn deep breathing and techniques for stress management 2. Managing problems: mechanism of action-identify 1 solvable practical problem, brainstorm possible solutions together 3. Get going, keep doing: mechanism of action-learn about depression and inactivity, identify and plan small enjoyable activities 4. Strengthen social support: mechanism of action-discuss a range of social support resources, make plan to increase social support 5. Staying well: mechanism of action- this session reviews all of the mechanisms of action in the prior 4 sessions

Group Problem Management+ and VR/mental health literacy

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Logie CH, Okumu M, Kortenaar JL, Gittings L, Khan N, Hakiza R, Kibuuka Musoke D, Nakitende A, Katisi B, Kyambadde P, Khan T, Lester R, Mbuagbaw L. Mobile Health-Supported Virtual Reality and Group Problem Management Plus: Protocol for a Cluster Randomized Trial Among Urban Refugee and Displaced Youth in Kampala, Uganda (Tushirikiane4MH, Supporting Each Other for Mental Health). JMIR Res Protoc. 2022 Dec 8;11(12):e42342. doi: 10.2196/42342.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Carmen Logie, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Logie, PhD

CONTACT

Moses Okumu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The two intervention arms will be compared to the control arm of the study using a pre- and post-intervention survey. There will also be a follow-up survey 8 weeks after the study is complete.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 23, 2021

First Posted

January 12, 2022

Study Start

January 31, 2022

Primary Completion

May 27, 2022

Study Completion

May 27, 2022

Last Updated

January 12, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will become available 12 months after study completion.
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.