Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508900479778 Date of Registration: 01/08/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Optimizing the Shamiri Program Delivery in Secondary Schools in Kenya: A Series of A/B Tests on Supervision, Training, and Intervention Efficacy
Official scientific title Optimizing the Shamiri Program Delivery in Secondary Schools in Kenya: A Series of A/B Tests on Supervision, Training, and Intervention Efficacy
Brief summary describing the background and objectives of the trial Youth in Sub-Saharan Africa face significant mental health challenges, contributing to academic, social, and vocational difficulties. In Kenya, nearly half of young people report symptoms of depression and anxiety, yet access to traditional mental health care is severely limited due to high costs, a lack of mental health professionals, and societal stigma. To address this gap, the Shamiri Intervention was developed as a low-cost, scalable, and stigma-free approach. Shamiri is a structured, four-week program led by lay-providers and incorporates growth mindset, gratitude, and value affirmation to improve well-being. Previous gold-standard RCTs, including those published in JAMA Psychiatry, have demonstrated Shamiri’s effectiveness in reducing depression and anxiety while improving academic outcomes and interpersonal relationships. Given its promising results, this study seeks to optimize Shamiri for broader dissemination through a series of A/B tests. The trial aims to refine key aspects of the intervention by evaluating different supervision models, training approaches, implementers, contexts, and AI-assisted tools. Specifically, it will assess the impact of structured supervision on lay-provider performance, determine the optimal supervisor-to-fellow ratio, compare training models for new and returning lay-providers, test the efficacy of the intervention when conducted in a rural setting and by a different implementer (doer), and examine AI-powered supervision for quality control. The findings will guide cost-effective scaling strategies while ensuring the program maintains high impact and fidelity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 19/05/2025
Actual trial start date
Anticipated date of last follow up 30/07/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 3472
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Treatment As Usual 4 weeks Will follow the standard supervision model with weekly check-ins and periodic feedback 334 Active-Treatment of Control Group
Experimental Group Shamiri Intervention 60-minute sessions per week 4 weeks Implement an enhanced supervision model with structured, more frequent feedback sessions 334
Control Group Treatment As Usual 4 weeks Maintain the current Supervisor-to-Fellow ratio of 1:10 334 Active-Treatment of Control Group
Experimental Group Shamiri Intervention 60-minute sessions per week 4 weeks Will have an increased supervisor-to-fellow ratio of 1:15 334
Control Group Treatment As Usual 4 weeks Both new and returning fellows (lay providers) receive the same standardized training 334 Active-Treatment of Control Group
Experimental Group Shamiri Intervention 60-minute sessions per week 4 weeks Returning fellows (lay providers) receive an advanced, targeted training module, while new fellows undergo foundational training.  334
Control Group Treatment As Usual 4 weeks Receive standard supervision involving manual feedback and periodic check-ins 334 Active-Treatment of Control Group
Experimental Group Shamiri Intervention 60-minute sessions per week 4 weeks Receive AI-powered supervision incorporating automated session analysis and real-time AI-generated feedback. 334
Control Group Waitlist Control 4 weeks Participants in the control group will be on a waitlist, only completing questionnaires. They will receive a summary of the intervention at the end of the 1-month follow up. 400 Active-Treatment of Control Group
Experimental Group Shamiri Intervention 60-minute sessions per week 4 weeks The intervention will be conducted by a partner implementer(doer) in a rural area unlike the previous urban contexts. 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 virtues. Additionally, each week, the participants will receive homework assignments to reinforce what they have learned and integrate it into their lives. During session one, students are guided through a growth mindset approach and how it allows individuals to grow in the face of life challenges. They learn didactic information about neuroplasticity and hear testimonials related to individuals’ academic/professional, interpersonal, and emotional growth. In session two, group leaders introduce a discussion and activities about effective strategies for growth. Then, they introduce a framework for problem-solving. The participants will do activities related to effective strategies for growth and problem-solving to help them understand and apply these strategies. In session three, participants learn the concept of gratitude and its benefits for well-being. They participate in a series of activities to apply this concept. Participants will complete a writing activity during which students write a gratitude letter to someone they wish to thank. They will also learn about gratitude by listing three good things each day. In the fourth and last session, participants are introduced to the concept of values. Participants discuss stories of culturally-pertinent role models, the values these individuals display, and how these values allowed the person to lead a successful and happy life. Group leaders may also share their own stories on personal virtues and participants may discuss these and other pertinent examples. In a writing assignment, participants will receive a sheet with a list of virtues and choose some of personal relevance. They will write about times when they have demonstrated the virtue(s) they select. 400
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Students are eligible to be included if they are a high school student in one of the selected schools between the ages of 12 and 21 This is a universal intervention, we will not screen participants in any way or apply other inclusion or exclusion criteria Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 12 Year(s) 21 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/06/2025 Daystar University Institutional Scientific and Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Daystar University Nairobi Campus Nairobi 1234 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Changes in self-reported depression symptoms as measured by the Patient Health Questionnaire - 8 Baseline and 4-week endpoint
Primary Outcome Changes in self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener-7 Baseline and 4-week endpoint
Secondary Outcome Changes in the self-reported mental well-being of participants measured by the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) Baseline and 4-week endpoint
Secondary Outcome Changes in self-reported perceived social support, as measured by the Multidimensional Scale of Perceived Social Support Baseline and 4-week endpoint
Secondary Outcome Assessment of the feasibility and acceptability of the intervention and well-being as reported by participants and intervention facilitators through semi-structured interviews Baseline and 4-week endpoint
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shamiri Institute Chania Avenue, Nairobi Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Shamiri USA 125 Western Avenue, Alliston, MA, Alliston, Boston, USA Boston 02134 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shamiri USA 125 Western Avenue, Alliston, MA, Alliston, Boston, USA Boston 02134 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Tom Osborn 13th Floor, Pioneer Point, Chania Avenue Nairobi 00300 Kenya
Dr. Maureen Ngesa 13th Floor, Pioneer Point, Chania Avenue Nairobi 00300 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tom Osborn osborn@shamiri.institute +254706408811 13th Floor, Pioneer Point, Chania Avenue
City Postal code Country Position/Affiliation
Nairobi 00300 Kenya Shamiri Institute
Role Name Email Phone Street address
Public Enquiries Tom Osborn osborn@shamiri.institute +254706408811 13th Floor, Pioneer Point, Chania Avenue
City Postal code Country Position/Affiliation
Nairobi 00300 Kenya Shamiri Institute
Role Name Email Phone Street address
Scientific Enquiries Rosine Mumanya baseke@shamiri.institute +254797326413 13th Floor, Pioneer Point, Chania Avenue
City Postal code Country Position/Affiliation
Nairobi 00300 Kenya Shamiri Institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article that results from this trial, after de-identification (text, tables, figures, and appendices). Analytic Code,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 3 years following article publication. Access to study reports and protocols will be open. Access to de-identified individual participant data will be available upon request from the study team.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 31/07/2025 Inclusion of rural vs urban and implementer A/B test Youth in Sub-Saharan Africa face significant mental health challenges, contributing to academic, social, and vocational difficulties. In Kenya, nearly half of young people report symptoms of depression and anxiety, yet access to traditional mental health care is severely limited due to high costs, a lack of mental health professionals, and societal stigma. To address this gap, the Shamiri Intervention was developed as a low-cost, scalable, and stigma-free approach. Shamiri is a structured, four-week program led by lay-providers and incorporates growth mindset, gratitude, and value affirmation to improve well-being. Previous gold-standard RCTs, including those published in JAMA Psychiatry, have demonstrated Shamiri’s effectiveness in reducing depression and anxiety while improving academic outcomes and interpersonal relationships. Given its promising results, this study seeks to optimize Shamiri for broader dissemination through a series of A/B tests. The trial aims to refine key aspects of the intervention by evaluating different supervision models, training approaches, and AI-assisted tools. Specifically, it will assess the impact of structured supervision on lay-provider performance, determine the optimal supervisor-to-fellow ratio, compare training models for new and returning lay-providers, and examine AI-powered supervision for quality control. The findings will guide cost-effective scaling strategies while ensuring the program maintains high impact and fidelity. Youth in Sub-Saharan Africa face significant mental health challenges, contributing to academic, social, and vocational difficulties. In Kenya, nearly half of young people report symptoms of depression and anxiety, yet access to traditional mental health care is severely limited due to high costs, a lack of mental health professionals, and societal stigma. To address this gap, the Shamiri Intervention was developed as a low-cost, scalable, and stigma-free approach. Shamiri is a structured, four-week program led by lay-providers and incorporates growth mindset, gratitude, and value affirmation to improve well-being. Previous gold-standard RCTs, including those published in JAMA Psychiatry, have demonstrated Shamiri’s effectiveness in reducing depression and anxiety while improving academic outcomes and interpersonal relationships. Given its promising results, this study seeks to optimize Shamiri for broader dissemination through a series of A/B tests. The trial aims to refine key aspects of the intervention by evaluating different supervision models, training approaches, implementers, contexts, and AI-assisted tools. Specifically, it will assess the impact of structured supervision on lay-provider performance, determine the optimal supervisor-to-fellow ratio, compare training models for new and returning lay-providers, test the efficacy of the intervention when conducted in a rural setting and by a different implementer (doer), and examine AI-powered supervision for quality control. The findings will guide cost-effective scaling strategies while ensuring the program maintains high impact and fidelity.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 20/06/2025 We are combining both studies (Optimizing the Shamiri Program Delivery in Secondary Schools in Kenya: A Series of A/B Tests on Supervision, Training, and Intervention Efficacy and Testing implementer efficacy and context effects on the Shamiri Intervention among adolescents in Kenya) into one record 2672 3472
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2025 Combining the two records (Optimizing the Shamiri Program Delivery in Secondary Schools in Kenya: A Series of A/B Tests on Supervision, Training, and Intervention Efficacy and Testing implementer efficacy and context effects on the Shamiri Intervention among adolescents in Kenya) into one Control Group, Waitlist, , 4 weeks, Participants in the control group will be on a waitlist, only completing questionnaires. They will receive a summary of the intervention at the end of the 1-month follow up., 400, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2025 Giving the test group intervention name Experimental Group, Shamiri Intervention, 60-minute sessions per week, 4 weeks, Implement an enhanced supervision model with structured, more frequent feedback sessions, 334,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2025 Adding this as we have combined the two records (Optimizing the Shamiri Program Delivery in Secondary Schools in Kenya: A Series of A/B Tests on Supervision, Training, and Intervention Efficacy and Testing implementer efficacy and context effects on the Shamiri Intervention among adolescents in Kenya) into one Control Group, Waitlist Control, , 4 weeks, Participants in the control group will be on a waitlist, only completing questionnaires. They will receive a summary of the intervention at the end of the 1-month follow up., 400, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2025 No dose for the control group. Participants fill data at specific points only Control Group, Treatment As Usual, , 4 weeks, Will follow the standard supervision model with weekly check-ins and periodic feedback, 334, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2025 No dose for the control group. Participants fill data at specific points only Control Group, Treatment As Usual, , 4 weeks, Maintain the current Supervisor-to-Fellow ratio of 1:10, 334, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2025 Giving the test group intervention name Experimental Group, Test Group, 60-minute sessions per week, 4 weeks, Will have an increased supervisor-to-fellow ratio of 1:15, 334, Experimental Group, Shamiri Intervention, 60-minute sessions per week, 4 weeks, Will have an increased supervisor-to-fellow ratio of 1:15, 334,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2025 No dose for the control group. Participants fill data at specific points only Control Group, Treatment As Usual, 60-minute sessions per week, 4 weeks, Both new and returning fellows (lay providers) receive the same standardized training, 334, Active-Treatment of Control Group Control Group, Treatment As Usual, , 4 weeks, Both new and returning fellows (lay providers) receive the same standardized training, 334, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2025 Giving the test group intervention name Experimental Group, Test Group, 60-minute sessions per week, 4 weeks, Returning fellows (lay providers) receive an advanced, targeted training module, while new fellows undergo foundational training. , 334, Experimental Group, Shamiri Intervention , 60-minute sessions per week, 4 weeks, Returning fellows (lay providers) receive an advanced, targeted training module, while new fellows undergo foundational training. , 334,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2025 No dose for the control group. Participants fill data at specific points only Control Group, Treatment As Usual, 60-minute sessions per week, 4 weeks, Receive standard supervision involving manual feedback and periodic check-ins, 334, Active-Treatment of Control Group Control Group, Treatment As Usual, , 4 weeks, Receive standard supervision involving manual feedback and periodic check-ins, 334, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2025 Giving the test group intervention name Experimental Group, Test Group, 60-minute sessions per week, 4 weeks, Receive AI-powered supervision incorporating automated session analysis and real-time AI-generated feedback. , 334, Experimental Group, Shamiri Intervention , 60-minute sessions per week, 4 weeks, Receive AI-powered supervision incorporating automated session analysis and real-time AI-generated feedback. , 334,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2025 Adding this as we have combined the two records (Optimizing the Shamiri Program Delivery in Secondary Schools in Kenya: A Series of A/B Tests on Supervision, Training, and Intervention Efficacy and Testing implementer efficacy and context effects on the Shamiri Intervention among adolescents in Kenya) into one Control Group, Waitlist Control, , 4 weeks, Participants in the control group will be on a waitlist, only completing questionnaires. They will receive a summary of the intervention at the end of the 1-month follow up., 400, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2025 Adding this as we have combined the two records (Optimizing the Shamiri Program Delivery in Secondary Schools in Kenya: A Series of A/B Tests on Supervision, Training, and Intervention Efficacy and Testing implementer efficacy and context effects on the Shamiri Intervention among adolescents in Kenya) into one Experimental Group, Shamiri Intervention, 60-minute sessions per week, 4 weeks, 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 virtues. Additionally, each week, the participants will receive homework assignments to help reinforce what they have learned and integrate it into their lives. During session one, students are guided through a growth mindset approach and how it allows individuals to grow in the face of life challenges. They learn didactic information about neuroplasticity and hear testimonials related to individuals’ academic/professional, interpersonal, and emotional growth. 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. The participants will do activities related to effective strategies for growth and problem-solving to help them understand and apply these strategies. In session three, participants learn the concept of gratitude and its benefits for well-being. They participate in a series of activities to apply this concept. Participants will be asked to complete a writing activity during which students write a gratitude letter to someone they wish to thank. They will also learn about the three good things activity in which they will list three good things each day. In the fourth and last session, participants are introduced to the concept of values. Participants may be introduced to and discuss stories of culturally-pertinent role models, the values these individuals display, and how these values allowed the person to lead a successful and happy life. Group leaders may also share their own stories on personal virtues, and participants may discuss these and other pertinent examples. In a writing assignment, participants will receive a sheet with a list of virtues and choose some of personal relevance. They will write about times when they have demonstrated the virtue(s) they select., 400,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 31/07/2025 Adding this as we have combined the two records (Optimizing the Shamiri Program Delivery in Secondary Schools in Kenya: A Series of A/B Tests on Supervision, Training, and Intervention Efficacy and Testing implementer efficacy and context effects on the Shamiri Intervention among adolescents in Kenya) into one Experimental Group, Shamiri Intervention, 60-minute sessions per week, 4 weeks, 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 virtues. Additionally, each week, the participants will receive homework assignments to help reinforce what they have learned and integrate it into their lives. During session one, students are guided through a growth mindset approach and how it allows individuals to grow in the face of life challenges. They learn didactic information about neuroplasticity and hear testimonials related to individuals’ academic/professional, interpersonal, and emotional growth. 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. The participants will do activities related to effective strategies for growth and problem-solving to help them understand and apply these strategies. In session three, participants learn the concept of gratitude and its benefits for well-being. They participate in a series of activities to apply this concept. Participants will be asked to complete a writing activity during which students write a gratitude letter to someone they wish to thank. They will also learn about the three good things activity in which they will list three good things each day. In the fourth and last session, participants are introduced to the concept of values. Participants may be introduced to and discuss stories of culturally-pertinent role models, the values these individuals display, and how these values allowed the person to lead a successful and happy life. Group leaders may also share their own stories on personal virtues, and participants may discuss these and other pertinent examples. In a writing assignment, participants will receive a sheet with a list of virtues and choose some of personal relevance. They will write about times when they have demonstrated the virtue(s) they select., 400, Experimental Group, Shamiri Intervention, 60-minute sessions per week, 4 weeks, The intervention will be conducted by a partner implementer(doer) in a rural area unlike the previous urban contexts. 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 virtues. Additionally, each week, the participants will receive homework assignments to reinforce what they have learned and integrate it into their lives. During session one, students are guided through a growth mindset approach and how it allows individuals to grow in the face of life challenges. They learn didactic information about neuroplasticity and hear testimonials related to individuals’ academic/professional, interpersonal, and emotional growth. In session two, group leaders introduce a discussion and activities about effective strategies for growth. Then, they introduce a framework for problem-solving. The participants will do activities related to effective strategies for growth and problem-solving to help them understand and apply these strategies. In session three, participants learn the concept of gratitude and its benefits for well-being. They participate in a series of activities to apply this concept. Participants will complete a writing activity during which students write a gratitude letter to someone they wish to thank. They will also learn about gratitude by listing three good things each day. In the fourth and last session, participants are introduced to the concept of values. Participants discuss stories of culturally-pertinent role models, the values these individuals display, and how these values allowed the person to lead a successful and happy life. Group leaders may also share their own stories on personal virtues and participants may discuss these and other pertinent examples. In a writing assignment, participants will receive a sheet with a list of virtues and choose some of personal relevance. They will write about times when they have demonstrated the virtue(s) they select., 400,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 27/06/2025 Study has received ethics approval FALSE, Daystar University Institutional Scientific and Ethical Review Committee, Daystar University Nairobi Campus, Nairobi, 1234, Kenya, 28 May 2025, , +254709972000, duiserc@daystar.ac.ke, TRUE, Daystar University Institutional Scientific and Ethical Review Committee, Daystar University Nairobi Campus, Nairobi, 1234, Kenya, 28 May 2025, 10 Jun 2025, +254709972000, duiserc@daystar.ac.ke, 33575_31858_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 28/05/2025 Changing the intended application to Daystar University Institutional Scientific and Ethical Review Committee FALSE, Maseno University Ethics Review Committee , Maseno University Main Campus, Maseno, 40100, Kenya, 14 Apr 2025, , +254722203411, muerc-secretariate@maseno.ac.ke, FALSE, Daystar University Institutional Scientific and Ethical Review Committee, Daystar University Nairobi Campus, Nairobi, 1234, Kenya, 28 May 2025, , +254709972000, duiserc@daystar.ac.ke,