Dissemination Strategies and Implementation Outcomes of Adolescent Character Strength Interventions.

NCT ID: NCT05365503

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2022-10-31

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.

Conditions

Mental Health Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Shamiri Intervention

The Shamiri intervention group will recieve a brief character strength intervention that will be delivered over the span of 4 weeks. There will be four sessions each lasting one hour each.

Group Type: EXPERIMENTAL

Shamiri Intervention

Intervention Type: OTHER

The first two sessions focus on the concept of growth mindset, the third session focuses on gratitude, and the fourth and final session focuses on values. In session one, participants are guided through a Growth mindset intervention designed to convey the idea that people and their situations can change for the better. In session two, group leaders introduce a discussion and activities about effective strategies for growth. Then, the group leaders introduce a framework for problem solving. In session three, group leaders emphasize the importance of verbalizing and consciously thinking about Gratitude, as well as its benefits for well-being. In the final session, participants are introduced to the concept of values. Participants discuss stories of culturally pertinent role models, with an emphasis on the values these individuals display, and how their values guided their life decisions and led to success and happiness.

Interventions

Shamiri Intervention

The first two sessions focus on the concept of growth mindset, the third session focuses on gratitude, and the fourth and final session focuses on values. In session one, participants are guided through a Growth mindset intervention designed to convey the idea that people and their situations can change for the better. In session two, group leaders introduce a discussion and activities about effective strategies for growth. Then, the group leaders introduce a framework for problem solving. In session three, group leaders emphasize the importance of verbalizing and consciously thinking about Gratitude, as well as its benefits for well-being. In the final session, participants are introduced to the concept of values. Participants discuss stories of culturally pertinent role models, with an emphasis on the values these individuals display, and how their values guided their life decisions and led to success and happiness.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Africa Mental Health Research and Training Foundation

UNKNOWN

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

Kenyatta University

OTHER

Sponsor Role: collaborator

WU Vienna University of Economics and Business

UNKNOWN

Sponsor Role: collaborator

Shamiri Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom L Osborn

Role: PRINCIPAL_INVESTIGATOR

Shamiri Institute

Locations

Shamiri Institute

Kiambu, Central Province, Kenya

Africa Mental health Research and Training Foundation

Makueni, Eastern Province, Kenya

Shamiri Institute

Nairobi, , Kenya

Countries

Kenya

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Templeton 2 Phase 2

Identifier Type: -

Identifier Source: org_study_id