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.: PACTR202104716135752 Date of Approval: 19/04/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Five-Arm Shamiri Trial
Official scientific title Dismantling the Shamiri Intervention for Anxiety, Depression, Wellbeing, and Academic Functioning in Kenyan Adolescents: Study Protocol for a Five-Arm Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Treatments for youth mental disorders are a public health priority, especially in sub-Saharan Africa (SSA), where treatment options remain limited due to high cost, elevated stigma, and lack of trained mental health professionals. One brief, accessible, and non-stigmatizing community-based intervention delivered by lay-providers, called the Shamiri Intervention, has been shown to significantly reduce depression and anxiety symptoms and improve social support and academic performance in Kenyan adolescents relative to a control group. The Shamiri Intervention consists of three elements (growth mindset, gratitude, and value affirmation). In this five-arm randomized controlled trial, we will test each of the individual intervention components (growth mindset, gratitude, and value affirmation) against the full Shamiri Intervention and against a study-skills control intervention. Students (N=1288) at participating secondary schools who are interested in participating in this universal intervention will be randomized in equal numbers into the five groups. The students will meet for four weeks, for one hour per week, in groups of 8-15 students led by local high school graduate lay-providers. Multi-level models will be used to compare trajectories over time of the primary outcomes (depressive symptoms, anxiety symptoms, academic performance, and wellness) and secondary outcomes in each intervention group to the control group. We hypothesize that all intervention groups will outperform the control on primary outcomes. This trial will shed light on the mechanisms and outcomes targeted by each individual intervention, helping prioritize which elements are most important to disseminate.
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 01/05/2021
Actual trial start date
Anticipated date of last follow up 31/03/2022
Actual Last follow-up date 31/03/2022
Anticipated target sample size (number of participants) 1288
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
U111112649284 WHO Primary Registries
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 Study Skills 60-minute sessions per week 4 weeks The study skills control intervention, like the other active interventions, lasts for four hours spread across four weeks. It is an active control intervention designed to control for all the non-specific aspects of group psychotherapy including meeting in a group of students with a trained lay-provider once a week, having discussions, completing activities in-session, and completing homework assignments. Additionally, because students in Kenya suffer at high rates of depression and anxiety symptoms from undue family, school, and peer-induced pressure to succeed academically, there is good reason to believe that this study-skills control intervention will somewhat alleviate symptoms of mental health problems. Previous trials using a study skills control arm in this population support the fact that it has some effects on mental health problems. This study skills control intervention includes exercises and group discussions about study strategies to improve academic performance, with a particular focus on note-taking and the cycle of studying activities (e.g., previewing content, self-assessment). Within-session activities include reading a short article to practice note-taking strategies, sharing in pairs their understanding of the strategies discussed, and discussing the content and its applications as a large group. Between-session take-home assignments include filling out worksheets that enable the participants to further practice the study skills and reflect on whether their learning improved as a result of the skills. 258 Active-Treatment of Control Group
Experimental Group Growth Intervention 60-minute sessions per week 4 weeks The growth-mindset intervention challenges the assumption that personality traits and intelligence are fixed. It is designed to strengthen individuals’ belief that the brain can adaptively respond to obstacles in various aspects of life (e.g. academic, interpersonal, and personality traits). Sessions will also focus on teaching strategies for growth such as problem-solving, and each session will be followed by a homework assignment for further applied practice and consolidation. The intervention includes didactics, activities, and group discussion. During session one, participants first learn about and discuss the idea that we can grow in the face of challenges; they learn about research on neuroplasticity showing that our brain is able to adapt and grow as we act and think differently, thus enabling us to improve and grow over time with effort. Then, in session two, they read and discuss testimonials depicting others’ experiences with a growth mindset, write their own growth stories, and participate in a group discussion led by the lay-provider to share these stories, and complete a saying is believing activity in which they write a letter to a friend about what they have learned. In session three, the lay-provider introduces a discussion and activities about effective strategies for growth, including the STEPS framework for problem-solving. The groups then practice what they have learned in the final session by setting specific goals for growth and considering how they might achieve them, before reviewing everything they have learned and considering which parts may be most useful to them in the future. 258
Experimental Group Gratitude Intervention 60-minute sessions per week 4 weeks The gratitude-only intervention focuses on promoting intentionally noticing, communicating, and appreciating feelings of thankfulness. Throughout the four one-hour small group (8-15 student) sessions, participants learn the concept of gratitude and apply the skills necessary for practicing gratitude in various aspects of life (e.g., interpersonal relationships, academics). Participants also receive take-home assignments each week (such as an activity in which they notice three good things a day) to implement what they have learned and started forming a habit of giving thanks. In the gratitude intervention sessions, participants first learn didactic information about gratitude and its effects on our wellbeing and discuss their understanding of and experiences with gratitude in their own lives. In session two, they hear testimonials from others for whom gratitude and appreciative behaviors improved their lives and write about and discuss examples of their experiences with gratitude and means of expressing gratitude. Then, through subsequent in-session activities in session 3, they consider things about themselves for which they can be grateful, consider and practice new ways of expressing their gratitude, and write a gratitude letter to someone they especially want to thank. In the final session, they practice savoring good experiences in the moment and have a concluding discussion to review all they learned and consider which aspects of it they will use in their life going forward. 258
Experimental Group Value Affirmation Intervention 60-minute sessions per week 4 weeks The value affirmation intervention aims to teach the concept of noticing and living according to personal core values. Participants practice self-reflection on specific values that are most important to them, learn the necessary skills to apply values to their life, and set goals that are aligned with their values. After each session, participants complete weekly assignments meant to help them consolidate and apply what they have learned. This value affirmation intervention opens with the lay-providers introducing and leading a discussion about the concept of values. Students then discuss in small groups their own understanding of values, as well as some of the most relevant ones to them. In session two, participants are presented with testimonials of culturally-pertinent role models with a focus on the values they demonstrate, and how these values have helped lead these individuals to live a happy and successful life. During this session, participants receive a sheet with a list of values and select some of the relevant values for a writing activity, which asks participants to reflect on times when they demonstrated these important personal values. Participants are asked to reflect on how they can live more in accordance with their values. In session three, they work to set short- and long-term goals related to their values and plan how to accomplish these goals through concrete steps. They are then asked to write a letter to someone that demonstrates values they personally admire. Session four includes thinking through how values could inform actions in a series of hypothetical, and then real, scenarios, during which students apply their values to come up with paths forward to handle problems. Finally, the participants have a concluding discussion to review what they learned and consider which aspects of it they plan to continue to use in their lives. 258
Experimental Group Shamiri Intervention 60-minute sessions per week 4 weeks The first two sessions of the Shamiri Intervention focus on the concept of growth mindset and strategies for growth, the third session focuses on gratitude, and the fourth and final session focuses on value affirmation. Additionally, participants receive between-session assignments to help reinforce what they have learned and integrate the new skills 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, participants are introduced to effective strategies for growth such as problem-solving. They complete a saying is believing activity by writing a letter advising a hypothetical high school friend about a life challenge to help them understand and apply what they have learned. 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. One activity includes writing a gratitude letter to someone they wish to thank and another asks participants to consider things about themselves for which they are grateful, while another asks participants to list three good things they are grateful for each day. In the fourth and last session, participants are introduced to the concept of values. They 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. Students also complete a writing activity about times when they have demonstrated one core and consider future goals aligned with that value. 258
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants must be aged between 12 and 21 Participants are high school students attending a high school in Kenya. There are no other exclusion criteria beyond the inclusion criteria listed above. Should more participants meet the inclusion criteria than is logistically feasible for the indicated group sizes and numbers of group leaders, participants (who have met the inclusion criteria) will be randomly selected to take part in the program. This is a universal intervention, so the youth do not need to meet a symptom threshold. 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 01/02/2021 Kenyatta University Directorate of Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
P.O Box 43844, Nairobi, 00100 Nairobi 00100 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, 2-week midpoint, 4-week endpoint, 1-month, 3-month, 6-month, and 9-month follow-up
Primary Outcome Changes in self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener Baseline, 2-week midpoint, 4-week endpoint, 1 month, 3 month, 6 month, and 9 month follow-up
Primary Outcome Changes in average academic grade from school-term before participation to school-term after participation, as measured by the average grade achieved by student across all enrolled students. As participants will be students from various classes and in various schools, student average grades will be rescaled, a mean of 60 and SD of 10 will be used in rescaling. School-term before participation - Term 1: July-Oct, 2021, School-term during participation - Term 2: Oct-Dec, 2021, School-term after participation - Term 3: Jan-April, 2022
Primary Outcome Changes in the mental well-being of participants measured by the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) Baseline, 2-week midpoint, 4-week endpoint, 1 month, 3 month, 6 month, and 9 month follow-up
Secondary Outcome Changes in adolescent wellbeing, as measured by the EPOCH Measure of Adolescent Well-Being Baseline, 4-week endpoint, 2-week follow-up
Secondary Outcome Changes in self-reported Gratitude from baseline to 2-week follow-up, as measured by a 6-item version of the Gratitude Questionnaire. Baseline, 2-week midpoint, 4-week endpoint, 1 month, 3 month, 6 month, and 9 month follow-up
Secondary Outcome Changes in perceived sense of purpose and meaning in life, as measured by the Purpose in Life Scale-12 Baseline, 2-week midpoint, 4-week endpoint, 1-month, 3-month, 6-month, and 9-month follow-up
Secondary Outcome Changes in self-reported implicit theories of personality about whether people’s attributes are fixed or are malleable, as measured by the 3-item Implicit Personality Theory Questionnaire Baseline, 2-week midpoint, 4-week endpoint, 1-month, 3-month, 6-month, and 9-month follow-up
Secondary Outcome Changes in perceived social support, as measured by the Multidimensional Scale of Perceived Social Support, 8 items Baseline, 4-week endpoint,1-month, 3-month, 6-month, and 9-month follow-up
Secondary Outcome Self-reported opinions on the acceptability and feasibility of the intervention, as measured by the Acceptability of Intervention Measure. 4-week endpoint
Secondary Outcome Self-reported opinions on whether the intervention is appropriate, as measured by the Intervention Appropriateness Measure. 4-week endpoint
Secondary Outcome The demographic questionnaire asks participants to report their basic demographic information, including their age, year in school, gender, family financial status, religion, county of origin, location of home (e.g., rural, urban), and the tribe they belong to. Baseline
Secondary Outcome A feedback scale will be used to assess participant's feedback about the program. The measure includes questions for participants about the interventions they participated in (e.g., which sessions they thought were most helpful). The measure also seeks other suggestions from participants about how the program can be improved for future implementation 4-week endpoint
Secondary Outcome The feedback questionnaire will be administered to ask for feedback from group leaders about the training they have received. There are two anonymous feedback questionnaires that group leaders will fill out; one will be distributed immediately post-training, and the other after the leaders have completed the program. Each questionnaire asks the group leaders to indicate their satisfaction with the training, on a scale of 1 (the training is terrible and makes them feel extremely unprepared) to 7 (the training is fantastic and makes them feel well-prepared to lead the sessions); the second section asks these leaders to circle, from 1 (strongly disagree) to 5 (strongly agree) , their thoughts on the quality of the training (e.g. whether the training is taught clearly) and if they become comfortable learning from the Shamiri team (e.g. whether the Shamiri team clearly conveys expectations and respect towards the group leaders during the training). The last section includes several short answer questions that ask these group leaders to give written feedback about the program and suggestions for improvement. 4-week endpoint
Secondary Outcome Changes in participants perceived control over themselves and their lives, measured by the Perceived Control Scale for Children, 6-item short form version. Baseline, 2-week midpoint, 4-week endpoint, 1-month, 3-month, 6-month, and 9-month follow up
Secondary Outcome Changes in 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. Baseline, 2-week midpoint, 4-week endpoint, 1-month, 3-month, 6-month, and 9-month follow up
Secondary Outcome Participants will be asked about the extent to which they have changed their thoughts and actions based on the character strength interventions. For each construct (gratitude, growth, and values), we will ask participants to complete items designed to assess the extent to which participants have intentionally thought about the character strength or acted based on the character strength over the past two weeks. 2-week midpoint, 4-week endpoint,1-month, 3-month, 6-month, and 9-month follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya High School Mandera Rd Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Templeton World Charity Foundation West Bay Street and Blake Rd., PO Box N-7776 Nassau Bahamas
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Templeton World Charity Foundation West Bay Street and Blake Rd., PO Box N-7776 Nassau Bahamas Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Huong Le 1153 Adams Dr San Jose 95132 United States of America
Emily Corrigan 6319 SE 45th Ave. Portland 97206 United States of America
Akash Wasil 34 Turnberry Court New York United States of America
Katherine Venturo Conerly 33 Kirkland Street Cambridge 02138 United States of America
Tom Osborn 12A Elgeyo Marakwet Road Nairobi Kenya
John Weisz 33 Kirkland Street Cambridge 02138 United States of America
Christine Wasanga P.O.Box 43844 00100 Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Tom Osborn osborn@shamiri.institute +254756121145 12A Elgeyo Marakwet Road
City Postal code Country Position/Affiliation
Nairobi Kenya Shamiri Institute
Role Name Email Phone Street address
Principal Investigator Christine Wasanga wasanga.christine@ku.ac.ke 0721355108 P.O.Box 43844 00100
City Postal code Country Position/Affiliation
Nairobi Kenya Kenyatta University Department of Psychology
Role Name Email Phone Street address
Scientific Enquiries Katherine Venturo Conerly venturoconerly@shamiri.institute +16099540542 80 Colleen Circle
City Postal code Country Position/Affiliation
Ewing 08638 United States of America Harvard University and Shamiri Institute
Role Name Email Phone Street address
Principal Investigator John Weisz john_weisz@harvard.edu +16174953832 33 Kirkland Street
City Postal code Country Position/Affiliation
Cambridge 02138 United States of America Harvard Laboratory for Youth Mental Health
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 at the request of the study team.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://osf.io/vynw9/ 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