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临床试验/NCT05365503
NCT05365503已完成不适用

Dissemination Strategies and Implementation Outcomes of Adolescent Character Strength Interventions.

Shamiri Institute3 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2022年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,000
试验地点
3
主要终点
Change in perceived social support from baseline to 1-month follow up

研究概览

简要总结

The present research study will involve investigating the efficacy of large-scale dissemination models of evidence-based character strength interventions in secondary schools in Kenya. This intervention, derived from a previously tested intervention named Shamiri, or thrive in Kiswahili, uses positive psychology and accessible life skills to build individual resilience and wellness. This will be a one-arm trial with participants recruited from 20 secondary schools in Nairobi, Kiambu and Makueni counties. The investigators estimate a sample size of 3000 youth, working on an intention to treat basis. All interested participants will be admitted to the program, with no exclusion criteria applied. The investigators will report on the efficacy of character strength interventions on wellbeing and mental health outcomes. Further, the investigators will also assess the scalability and acceptability of the program post intervention. Additionally, the investigators will examine moderator effects on the participants, baseline attributes of the participants, and potentially the effects of candidate mediators on intervention effects.

详细描述

This is a dissemination study whose objective is to explore the effectiveness, acceptability, and scalability of the Shamiri intervention when implemented in a large-scale naturalistic dissemination study in Kenyan secondary schools. Specifically, this study has two broad goals: 1) to test the effectiveness of Shamiri on mental health and psychosocial outcomes when delivered naturalistically on a large scale through either a centralized and de-centralized (train the trainers) administration, and 2) to examine and measure outcomes of these large-scale dissemination models.

For goal 1, participants will receive Shamiri directly through the Shamiri team or through an implementation partner. The investigators will measure mental health and psychosocial outcomes to determine if these outcomes compare to those reported in prior RCTs of Shamiri. The investigators hypothesize that participants receiving Shamiri will experience similar improvements in mental health and psychosocial outcomes as reported in previous RCTs. The investigators don't have a priori hypothesis on whether the mode through which the participants receive the intervention will affect intervention outcomes.

To achieve goal 2, investigators measure the following implementation related outcomes: intervention fidelity, cost, sustainment, acceptability, penetration, and cost-effectiveness. The investigators hypothesize that the Shamiri intervention will achieve high ratings in all intervention outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
12 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be high school students in one of the selected schools.
  • Participants must be between the ages of 12 to 21.

排除标准

  • There will be no other exclusion criteria.

结局指标

主要结局

Change in perceived social support from baseline to 1-month follow up

时间窗: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up

Self-reported sense of social support, measured by the Multidimensional Scale of Perceived Social Support, with a score range of 0-7, with higher scores indicating greater perception of social support

Change in anxiety symptoms from baseline to 1-month follow up

时间窗: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up

Self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener

Change in depression symptoms from baseline to 1-month follow up

时间窗: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up

Self-reported depression symptoms as measured by the Patient Health Questionnaire - 8

Change in self-reported well-being from baseline to 1-month follow up

时间窗: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up

Self-reported wellbeing, as measured by the Engagement, Perseverance, Optimism, Connectedness and Happiness Measure of Adolescent Well-Being, with a score range of 1-5, higher scores meaning better well-being

Change in academic performance from baseline to 1-month follow up

时间窗: Baseline (academic term pre-intervention) and up to 1-month post intervention

Academic performance, as measured by the average grade achieved from the school term before the intervention, the school term during which the intervention takes place, and the last term for which academic grades are available.

次要结局

  • Change in self-reported secondary control from baseline to 1-month follow up(Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up)
  • Change in sense of meaning and purpose in life from baseline to 1-month follow up(Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up)
  • Change in gratitude from baseline to 1-month follow up(Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up)
  • Change in perceived control from baseline to 1-month follow up(Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up)
  • Change in mental well-being from baseline to 1-month follow up(Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up)

研究者

发起方
Shamiri Institute
申办方类型
Other
责任方
Sponsor

研究点 (3)

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