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Dissemination Strategies and Implementation Outcomes of Adolescent Character Strength Interventions.

Primary Purpose

Mental Health Disorder

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Shamiri Intervention
Sponsored by
Shamiri Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mental Health Disorder focused on measuring Depression, Anxiety

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shamiri Institute
  • Africa Mental health Research and Training Foundation
  • Shamiri Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shamiri Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in anxiety symptoms from baseline to 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
Self-reported depression symptoms as measured by the Patient Health Questionnaire - 8
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
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
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.

Secondary Outcome Measures

Change in self-reported secondary control from baseline to 1-month follow up
Self-reported participant sense of secondary control, or the ability to adjust oneself to hardships in such a way as to control their subjective emotional impact, measured by the 6-item short form of the Secondary Control Scale for Children (score range of 0-18, higher scores indicating greater perceived secondary control)
Change in sense of meaning and purpose in life from baseline to 1-month follow up
Self-reported sense of purpose and meaning in life, as measured by the Purpose in Life Scale-12, with a score range of 20-140, higher scores indicating greater perceived meaning in life
Change in gratitude from baseline to 1-month follow up
Self-reported gratitude, measured by a 6-item version of the Gratitude Questionnaire, with a score range of 6-48, with higher scores indicating higher gratitude
Change in perceived control from baseline to 1-month follow up
Self-reported sense of control over oneself and one's life, measured by the Perceived Control Scale for Children, with a score range of 0-24, with a higher score indicating higher perception of control over one's life
Change in mental well-being from baseline to 1-month follow up
Self-reported mental well-being of participants measured by the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS), with a score range of 7-35, higher scores indicating higher positive mental well-being

Full Information

First Posted
April 25, 2022
Last Updated
February 1, 2023
Sponsor
Shamiri Institute
Collaborators
Africa Mental Health Research and Training Foundation, Harvard University, Kenyatta University, WU Vienna University of Economics and Business
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1. Study Identification

Unique Protocol Identification Number
NCT05365503
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shamiri Institute
Collaborators
Africa Mental Health Research and Training Foundation, Harvard University, Kenyatta University, WU Vienna University of Economics and Business

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorder
Keywords
Depression, Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shamiri Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Shamiri Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in anxiety symptoms from baseline to 1-month follow up
Description
Self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener
Time Frame
Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Title
Change in depression symptoms from baseline to 1-month follow up
Description
Self-reported depression symptoms as measured by the Patient Health Questionnaire - 8
Time Frame
Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Title
Change in perceived social support from baseline to 1-month follow up
Description
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
Time Frame
Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Title
Change in self-reported well-being from baseline to 1-month follow up
Description
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
Time Frame
Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Title
Change in academic performance from baseline to 1-month follow up
Description
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.
Time Frame
Baseline (academic term pre-intervention) and up to 1-month post intervention
Secondary Outcome Measure Information:
Title
Change in self-reported secondary control from baseline to 1-month follow up
Description
Self-reported participant sense of secondary control, or the ability to adjust oneself to hardships in such a way as to control their subjective emotional impact, measured by the 6-item short form of the Secondary Control Scale for Children (score range of 0-18, higher scores indicating greater perceived secondary control)
Time Frame
Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Title
Change in sense of meaning and purpose in life from baseline to 1-month follow up
Description
Self-reported sense of purpose and meaning in life, as measured by the Purpose in Life Scale-12, with a score range of 20-140, higher scores indicating greater perceived meaning in life
Time Frame
Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Title
Change in gratitude from baseline to 1-month follow up
Description
Self-reported gratitude, measured by a 6-item version of the Gratitude Questionnaire, with a score range of 6-48, with higher scores indicating higher gratitude
Time Frame
Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Title
Change in perceived control from baseline to 1-month follow up
Description
Self-reported sense of control over oneself and one's life, measured by the Perceived Control Scale for Children, with a score range of 0-24, with a higher score indicating higher perception of control over one's life
Time Frame
Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up
Title
Change in mental well-being from baseline to 1-month follow up
Description
Self-reported mental well-being of participants measured by the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS), with a score range of 7-35, higher scores indicating higher positive mental well-being
Time Frame
Baseline, 2-week mid-point, 4-week end-point, and 1-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom L Osborn
Organizational Affiliation
Shamiri Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shamiri Institute
City
Kiambu
State/Province
Central Province
Country
Kenya
Facility Name
Africa Mental health Research and Training Foundation
City
Makueni
State/Province
Eastern Province
Country
Kenya
Facility Name
Shamiri Institute
City
Nairobi
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators intend to share fully de-identified data through publications and upon request.
IPD Sharing Time Frame
T.B.D.
IPD Sharing Access Criteria
T.B.D.

Learn more about this trial

Dissemination Strategies and Implementation Outcomes of Adolescent Character Strength Interventions.

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