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Clinical Trials/NCT05365503
NCT05365503CompletedNot Applicable

Dissemination Strategies and Implementation Outcomes of Adolescent Character Strength Interventions.

Shamiri Institute3 sites in 1 country3,000 target enrollmentStarted: May 16, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
3,000
Locations
3
Primary Endpoint
Change in perceived social support from baseline to 1-month follow up

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
12 Years to 21 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • There will be no other exclusion criteria.

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Shamiri Institute
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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