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.: PACTR202201600200783 Date of Approval: 21/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Long-term health effects of the Shamiri youth mental health program.
Official scientific title Long-term health outcomes for adolescent character strength interventions.
Brief summary describing the background and objectives of the trial The present research will involve evaluating the effectiveness of evidence-based interventions aimed to build character strengths (e.g., sense of purpose; gratitude; values), for their effects at long-term (3-4-year) follow-up on a variety of mental health, health, wellbeing, and academic/vocational outcomes in a large sample of Kenyan high-school students. The interventions-- all of which are derived from a previously- tested intervention named Shamiri or thrive in Kiswahili--use positive psychology and accessible life skills to build individual resilience and wellness. The effects of these interventions will be tested against a control group teaching study skills. Participants for this long-term follow-up study will be recruited from those who previously participated in three randomized controlled trials of the Shamiri Intervention: Shamiri 1.0, an RCT in 2018 with N=51 youths with elevated depression and/or anxiety symptoms; Shamiri 2.0, an RCT in 2019 with N=413 high-symptom youths across diverse school settings in Kenya; Shamiri 3.0, an ongoing, large-scale RCT that will compare the effects of the Shamiri Intervention and its constituent character strength interventions (i.e., growth mindset, gratitude, and value affirmations) against an active control group in a 5-arm RCT with ~1300 youths. In each of these trials, depression and anxiety symptoms, along with a variety of other outcomes, several of which differed among the trials, were measured. For this present follow-up study of the participants from these three trials, we anticipate and aim for a sample size of ~432 youths from the Shamiri Intervention and control groups for main analyses comparing these two groups. We anticipate that an additional 231 youths from the third trial who were assigned to the growth, gratitude, or values intervention will participate in this follow-up study and will be included in secondary analyses comparing these single-element interventions to the other conditions.
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,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 24/01/2022
Actual trial start date 24/01/2022
Anticipated date of last follow up 18/09/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 663
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
U111112724463 World Health Organization
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
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 values. In session one, participants were guided through a Growth mindset intervention designed to convey the idea that people and their situations can change for the better. The group leader presented the definitions of “Growth” and “neuroplasticity,” and participants heard testimonials related to individuals’ academic / professional, interpersonal, and emotional growth. In session two, group leaders introduced a discussion and activities about effective strategies for growth. Then, the group leaders introduced a framework for problem solving. In session three, participants were introduced to the concept of Gratitude. Group leaders emphasized the importance of verbalizing and consciously thinking about Gratitude, as well as its benefits for well-being. Participants also completed a writing activity during which students wrote a gratitude letter to someone they wished to thank. They also learned about the three good things activity in which they listed three good things each day. In the final session, participants were introduced to the concept of values. Participants discussed 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. Group leaders also shared their own stories on personal values, and participants discussed these and other pertinent examples. In a writing assignment, participants received a list of values and then wrote about times when they demonstrated one or more value(s) from the list. Group leaders also read a series of hypothetical scenarios and students applied their values to create solutions to the problems presented. This intervention has already been administered to all participants. 216
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. This control condition has already been administered to all participants. 216 Active-Treatment of Control Group
Experimental Group Growth Intervention 60-minute sessions per week 4 weeks The growth-mindset-only intervention is derived from the growth-mindset-focused portion of the Shamiri intervention, but expanded to fill four weeks. The 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 also focused on teaching strategies for growth such as problem-solving, and each session was 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. This intervention has already been administered to all participants. 77
Experimental Group Gratitude Intervention 60-minute sessions per week 4 weeks The gratitude-only intervention is derived from the gratitude-focused portion of the Shamiri intervention, but expanded to fill four 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. This intervention has already been administered to all participants. 77
Experimental Group Value Affirmation Intervention 60-minute sessions per week 4 weeks The values-only intervention is derived from the values-focused portion of the Shamiri intervention, but expanded to fill four 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 then 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 and consider how to apply these values beyond the program. 77
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants must have taken part in one of the three previous RCTs testing Shamiri and/or its component parts in small group settings. Participants must have had elevated symptoms of depression at baseline OR had elevated symptoms of anxiety at baseline. Participants in Shamiri's three previous RCTs that did not have elevated symptoms of depression or anxiety at baseline will be excluded. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 24 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 07/12/2021 Kenyatta University Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 43844 Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Self-reported depression symptoms as measured by the Patient Health Questionnaire - 8 3-4 year follow-up
Primary Outcome Self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener or GAD-7 3-4 year follow-up
Secondary Outcome Self-reported wellbeing, as measured by the EPOCH Measure of Adolescent Well-Being 3-4 year follow-up
Secondary Outcome Self-reported gratitude, as measured by a 6-item version of the Gratitude Questionnaire 3-4 year follow-up
Secondary Outcome Self-reported mental well-being of participants as measured by the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) 3-4 year follow up
Primary Outcome Self-reported sense of social support, measured by the Multidimensional Scale of Perceived Social Support, 8 items 3-4 year follow up.
Secondary Outcome Self-reported sense of purpose and meaning in life, as measured by the Purpose in Life Scale-12 3-4 year follow-up
Secondary Outcome Self-reported sense of control over oneself and their ones life, measured by the Perceived Control Scale for Children. 3-4 year follow up
Secondary Outcome 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 Secondary Control Scale for Children. 3-4 year follow up
Primary Outcome Academic performance as measured by the average grade achieved at the end of school term and KCSE results. 3-4 year follow-up
Secondary Outcome The demographic questionnaire, which asks participants to report their basic demographic information such as age, year in school, living situation, vocational status, gender, and educational status. 3-4 year follow up
Secondary Outcome Substance use will be measured using the Alcohol Smoking and Substance Involvement Screening Test (ASSIST), participants asked their history of alcohol, tobacco and other drug use. 3-4 year follow up
Secondary Outcome The Alcohol Use Disorders Identification Test (AUDIT), used to measure alcohol consumption, drinking behavior and alcohol-related problems. 3-4 year follow up
Secondary Outcome Pregnancy and children questionnaire, measured via in-person assessment by a nurse, to assess whether participants or their partners are currently pregnant or have been pregnant or have children since the study, and whether these were expected or not. 3-4 year follow up
Secondary Outcome HIV risk behavior and status, as measured by a series of question about HIV risk behavior and their HIV status. If participants do not know their HIV status and wish to get tested, participants will be invited to visit a national hospital for testing, and may report their status to the study team. 3-4 year follow up
Secondary Outcome Stress level and stress regulation as measured by an aggregate of heart rate variability over time (e.g., as an average over two weeks). 3-4 year follow-up
Secondary Outcome Physical activity levels, measured by steps and overall distance moved over time (e.g., an aggregate over two weeks). 3-4 year follow-up
Secondary Outcome Blood pressure 3-4 year follow up
Secondary Outcome Intimate partner violence will be measured using the Violence against women instrument VAWI, a questionnaire validated for men and women, and measuring both victimization and perpetration. 3-4 year follow up
Secondary Outcome Household wealth will be measured to assess participant socio-economic status based on their current living situation. 3-4 year follow up
Secondary Outcome History of hospitalization as measured by a self-reported list of hospitalization sessions including date, location, amount of time in the hospital, whether it was overnight, and the reason for hospitalization. 3-4 year follow-up
Secondary Outcome Body Mass Index, calculated using measures of Weight and Height. 3-4 year follow-up
Secondary Outcome Prescribed medication in the past year 3-4 year follow-up
Secondary Outcome Waist to Hip Ratio, calculated using Waist measurement and Hip measurement 3-4 year follow-up
Secondary Outcome Quality of sleep will be measured by the Adolescent Sleep-Wake Scale. 3-4 year follow-up
Primary Outcome Self-reported socio-economic status and quality of life 3-4 year follow-up
Primary Outcome Ravens test 3-4 year follow-up
Primary Outcome Stroop color and word test 3-4 year follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shamiri Institute 13th Floor, Pioneer Point, Chania Avenue Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Templeton World Charity Foundation West Bay Street and Blake Rd Nassau N-7776 Bahamas
The Agency Fund GDI Solutions 1401 K Street NW, Suite 900 Washington DC 20005 United States of America
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
Tom L Osborn Shamiri Institute Nairobi 6769-0030 Kenya
Katherine Venturo Conerly Harvard University, Shamiri Institute Cambridge 02138 United States of America
John Weisz 33 Kirkland Street Cambridge 02138 United States of America
David M. Ndetei Africa Mental Health Research and Training Foundation Nairobi 48423-001 Kenya
Christine Wasanga Kenyatta University Nairobi 00100 Kenya
Eve Puffer Duke University Durham 27708-008 United States of America
Thomas Rusch Welthandelsplatz Vienna 1020 Austria
Victoria Mutiso Africa Mental Health Research and Training Foundation Nairobi 48423-001 Kenya
Christine Musyimi Africa Mental Health Research and Training Foundation Nairobi 48423-001 Kenya
Natalie Johnson Shamiri Institute Nairobi 6769-0030 Kenya
Brenda Ochuku Shamiri Institute Nairobi 6769-0030 Kenya
Okoth Paul Okoth Shamiri Institute Nairobi 6769-0030 Kenya
Rosine Baseke Shamiri Institute Nairobi 6769-0030 Kenya
Kalori Wesonga Shamiri Institute Nairobi 6769-0030 Kenya
Sunehra Arif Shamiri Institute Nairobi 6769-0030 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 Kenya Shamiri Institute
Role Name Email Phone Street address
Scientific Enquiries Katherine Venturo Conerly venturoconerly@shamiri.institute +16099540542 33 Kirkland Street
City Postal code Country Position/Affiliation
Cambridge 02138 United States of America Shamiri Institute and Harvard University
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 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