Dissemination Strategies and Implementation Outcomes of Adolescent Character Strength Interventions.

NCT05365503 | Completed

• 1 other identifier: Templeton 2 Phase 2
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Mental Health Disorder

Keywords

Depression; Anxiety

Outcome Measures

Primary Outcomes (5)

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

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

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

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

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

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

• Change in perceived social support from baseline to 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

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

• Change in self-reported well-being from baseline to 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

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

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

  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.

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

Secondary Outcomes (5)

• 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

Study Arms (1)

Shamiri Intervention

EXPERIMENTAL

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.

Other: Shamiri Intervention

Interventions

Shamiri Intervention 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.

Shamiri Intervention

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Shamiri Institute: lead
• Africa Mental Health Research and Training Foundation: collaborator
• Harvard University: collaborator
• Kenyatta University: collaborator
• WU Vienna University of Economics and Business: collaborator

Study Sites (3)

Shamiri Institute

Kiambu, Central Province, Kenya

Location

Africa Mental health Research and Training Foundation

Makueni, Eastern Province, Kenya

Location

Shamiri Institute

Nairobi, Kenya

Location

MeSH Terms

Conditions

Mental Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Tom L Osborn

  Shamiri Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 9, 2022
• Study Start: May 16, 2022
• Primary Completion: June 30, 2022
• Study Completion: October 31, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: T.B.D.
• Access Criteria: T.B.D.

Locations

KE (3)