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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05187689
Other study ID # 40965
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 31, 2022
Est. completion date May 27, 2022

Study information

Verified date January 2022
Source University of Toronto
Contact Carmen Logie, PhD
Phone 6474544203
Email carmen.logie@utoronto.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 330
Est. completion date May 27, 2022
Est. primary completion date May 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Toronto Young African Refugees for Integral Development

Outcome

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