Advancing mHealth-supported Adoption and Sustainment of an Evidence-based Mental Health Intervention for Youth in a School-based Delivery Setting in Sierra Leone
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,454
- 试验地点
- 1
- 主要终点
- Fidelity
研究概览
简要总结
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.
详细描述
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 new mobile-based digital tools. The mHealth tools will support supervision through key features, including voice activated content, fillable forms (i.e., YRI fidelity checklist), visual dashboards to monitor fidelity, and training videos to support school-based YRI delivery.
The Exploration, Preparation, Implementation, Sustainment framework, a broad multilevel, context-sensitive implementation science model, will guide the study. 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.
Aim 1 (Exploration and Preparation) will investigate barriers and facilitators to successful YRI implementation aided by mobile-based tools in Sierra Leone's secondary schools. A mixed methods evaluation with teachers, principals, and government ministry officials will inform co-development of an implementation blueprint prior to YRI delivery. User-centered design methods will be used to adapt the mHealth supervision app and incorporate WhatsApp to create an integrated user model of mobile phone-based supervision. Aim 2 (Implementation) will examine the feasibility, acceptability, cost, and fidelity to the YRI delivered by teachers receiving mobile-based supervision compared with those receiving standard supervision via a mixed methods approach. Aim 3 (Impact of Delivery Approach on YRI Effectiveness) will compare the effectiveness of the YRI in improving mental health, emotion regulation and daily functioning in youth (aged 14-24) when delivered in school settings by teachers who receive either mobile-based supervision (N=480 youth) or those who receive standard supervision (N=480 youth). Aim 4 (Sustainment) will (a) investigate mechanisms of adoption and sustainment of the YRI delivered by teachers through a mixed methods evaluation with teachers, youth, and principals; and (b) conduct a cost-effectiveness and return on investment analysis to evaluate relative costs vs. benefits of the YRI from a broad societal perspective, including educational outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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.
研究组 & 干预措施
Control
Wait listed control
YRI+Mobile Supervision
Youth Readiness Intervention delivered by teachers receiving mobile-based supervision
干预措施: Youth Readiness Intervention (YRI) (Behavioral)
YRI+Standard Supervision
Youth Readiness Intervention delivered by teachers receiving standard supervision
干预措施: Youth Readiness Intervention (YRI) (Behavioral)
结局指标
主要结局
Fidelity
时间窗: For 12 weeks, starting from the date of the first YRI session
Fidelity will be measured with the YRI Fidelity Checklist, a tool developed and tested in previous trials that is completed after each YRI session.
Acceptability
时间窗: An average of 24 weeks
Acceptability, or the level of satisfaction with the intervention, will be assessed with the Johns Hopkins University Implementation Science Questionnaire. The scale has 12 items scored on a 4-point Likert scale: 1=Not at all, 2=A little bit, 3=A moderate amount, 4=A lot. Higher scores mean greater acceptability.
Appropriateness
时间窗: An average of 24 weeks
Appropriateness, or the relevance and fit of the intervention, will be assessed with Johns Hopkins University Implementation Science Questionnaire. The scale has 12 items scored on a 4-point Likert scale: 1=Not at all, 2=A little bit, 3=A moderate amount, 4=A lot. Higher scores mean greater appropriateness.
次要结局
- emotion regulation skills(An average of 24 weeks)
- Functional Impairment(An average of 1 year)
- Anxiety and Depression(An average of 24 weeks)