Advancing mHealth-supported Adoption and Sustainment of an Evidence-based Mental Health Intervent… (NCT05737667) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Advancing mHealth-supported Adoption and Sustainment of an Evidence-based Mental Health Intervention in Sierra Leone
Sierra Leone1,454 participantsStarted 2023-02-15
Plain-language summary
This study will examine a new implementation strategy for the Youth Readiness Intervention (YRI), an evidence-based mental health intervention. The strategy will (a) leverage a delivery setting (schools) and workforce (teachers) used effectively in low- and middle- income countries; and (b) innovate with technology and mHealth tools to enhance mental health service delivery quality. The YRI will be implemented as an extracurricular resilience-building after school activity in Sierra Leone. Teachers will deliver the YRI and receive either mobile phone-supported supervision or standard in-person supervision. Mobile-based supervision will integrate WhatsApp, a free cross-platform messaging and voice service used widely throughout Africa, with mHealth digital tools. The mHealth tools will support supervision through key features, including voice activated content, fillable forms (i.e., YRI fidelity checklist), and visual dashboards to monitor fidelity. A hybrid type 3 implementation-effectiveness design will allow for evaluation of both mobile phone-based supervision as a new implementation strategy, and clinical effectiveness of the YRI on youth mental and behavioral health as secondary outcomes.
Who can participate
Age range
14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
School Inclusion Criteria:
* We will include secondary schools in the Western Region that are willing to provide the Youth Readiness Intervention (YRI) as an extracurricular activity
School Exclusion Criteria:
* We will exclude schools that do not meet the inclusion criteria.
Teacher Inclusion Criteria:
* We will include teachers who are (a) currently employed at a Western Region urban or rural secondary school; (b) willing to provide the YRI as an extracurricular activity
Teacher Exclusion Criteria:
* We will exclude teachers who do meet inclusion criteria.
Youth Inclusion Criteria:
* We will include youth who are (a) currently enrolled in a secondary school in the Western Region (urban or rural); (b) male or female aged 14-24; (c) able to attend after school activities. We will require both youth assent and parental consent for all youth under age 18.
Youth Exclusion Criteria:
* We will exclude youth who do not meet all inclusion criteria and/or who report active, severe suicidality or psychosis as determined by a study social worker.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fidelity
Timeframe: For 12 weeks, starting from the date of the first YRI session