Clinical trial NCT05365503: Dissemination Strategies and Implementation Outcomes of Adolescent Character Strength Interventions.
Official title: Dissemination Strategies and Implementation Outcomes of Adolescent Character Strength Interventions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Disorder
Keywords: Depression
Anxiety
Lead sponsor: Shamiri Institute
Sponsor class: OTHER
Collaborators: name: Africa Mental Health Research and Training Foundation
name: Harvard University
name: Kenyatta University
name: WU Vienna University of Economics and Business
First posted: 2022-05-09
Enrollment: 3000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in anxiety symptoms from baseline to 1-month follow up
timeFrame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
measure: Change in depression symptoms from baseline to 1-month follow up
timeFrame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
measure: Change in perceived social support from baseline to 1-month follow up
timeFrame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
measure: Change in self-reported well-being from baseline to 1-month follow up
timeFrame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
measure: Change in academic performance from baseline to 1-month follow up
timeFrame: Baseline (academic term pre-intervention) and up to 1-month post intervention
Secondary outcomes:
measure: Change in self-reported secondary control from baseline to 1-month follow up
timeFrame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
measure: Change in sense of meaning and purpose in life from baseline to 1-month follow up
timeFrame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
measure: Change in gratitude from baseline to 1-month follow up
timeFrame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
measure: Change in perceived control from baseline to 1-month follow up
timeFrame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
measure: Change in mental well-being from baseline to 1-month follow up
timeFrame: Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Other outcomes:
Locations:
city: Kiambu
country: Kenya
facility: Shamiri Institute
state: Central Province
city: Makueni
country: Kenya
facility: Africa Mental health Research and Training Foundation
state: Eastern Province
city: Nairobi
country: Kenya
facility: Shamiri Institute
Study officials:
affiliation: Shamiri Institute
name: Tom L Osborn
role: PRINCIPAL_INVESTIGATOR
References: