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: www.pactr.org
Trial no.: PACTR201906525818462 Date of Approval: 20/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Four-Week Shamiri Wellness Program
Official scientific title The Shamiri Group Intervention for Adolescent Anxiety and Depression: A Randomized Controlled Trial of a Lay Provider-Delivered, School-Based Intervention in Kenya
Brief summary describing the background and objectives of the trial Developing low-cost and scalable interventions for youth depression and anxiety in low-income regions such as countries in Sub Saharan Africa is presently a critical priority of global mental health research. The need for such interventions is warranted because while the incidence of youth depression and anxiety is on the rise, less than half of youths with internalizing problems receive needed care. Shamiri is an intervention for youth depression and anxiety developed for adolescents in Kenya. The Shamiri intervention protocol draws upon evidence-based components of brief scalable interventions that involve non-clinical psychological principles (rather than treatment of psychopathology). The specific components of the protocol are growth-mindset, gratitude, and virtues or value affirmations. Students (approximately N = 550) with elevated depression and/or anxiety symptoms will be randomized into either the Shamiri treatment group or a study-skills control group. The students will meet in groups of 10-15 students that will be led by a peer group leader, who has undergone 10 hours of training as a lay provider, once a week for sixty minutes for four weeks. This study has two primary objectives. The first is to evaluate the efficacy of the Shamiri intervention for depression and anxiety for youths with elevated self-reported symptoms in Kenya. The second is to conduct a moderator analyses on study outcomes, in order to identify for whom the treatment works and under what circumstances. The primary outcomes of measures of the present study are youth depression and anxiety symptoms. The secondary outcomes measures are social support, perceived control, gratitude, loneliness, happiness, optimism and academic outcomes.
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 17/06/2019
Actual trial start date 18/06/2019
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 28/02/2020
Anticipated target sample size (number of participants) 576
Actual target sample size (number of participants) 413
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
U111112352132 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 Group 60 minutes, once a week 4 weeks The Shamiri intervention consists of three modules: a growth module lasting two sessions; a gratitude module lasting one session; and a virtues or value affirmations module lasting one session. In session one, participants learn about growth and personal improvement. Then, participants read an article and watch a video that describe the concepts of brain neuroplasticity and growth mindset. After this, the group reads testimonials about growth mindsets from well-known figures and hear their group leader’s testimonial. For homework, participants are asked to write about how they use growth to solve a problem. In session two, participants brainstorm and discuss effective strategies that they can use to apply the lessons of growth-mindset in their own lives. They then talk about problem-solving skills in a discussion moderated by the group-leader. After this, they write a letter to a friend in which they explain all the concepts that they have learnt thus far. For homework, participants are asked to think of a problem that is affecting them and employ a specific strategy learned in this session. In session three, students learn about gratitude. The group discusses gratitude and the things for which participants are grateful. Then, participants write a “gratitude letter” to someone who has changed their lives for the better. For homework, participants will have until the next session to identify and reflect on three things that happened each day. In session four, participants learn about virtues and complete a value affirmation exercise. Students are then asked to select, from a list, several values that are important to them. Additionally, they will write in more detail about the one value that they feel is most important to them, describing why this value is important and a time in which they have lived up to that value. Groups are led by group leaders trained on the Shamiri protocol for 10 hours. There will be 6 Shamiri groups with 6 group-leaders per site (school) 288
Control Group Study Skills 60-minute sessions per week 4 weeks To control for non-specific aspects of the intervention, the study skills control group will mirror the structure of the Shamiri intervention. Each condition contains the same number of exercises and group discussions, within-session activities are similar in format , and take-home assignments require similar effort. To begin session one, group leaders will offer a didactic introduction of the 5Rs of note-taking. Then, participants will read a short article and complete an exercise to practice the new note-taking method. For homework, participants will be asked to complete three tasks: They will 1) identify one particular class during which they use the 5Rs of note-taking, 2) describe how they used the 5Rs to take notes, and 3) reflect on whether their learning improved as a result of using the new note-taking strategy. During session two, group leaders will first introduce ten effective study strategies. Participants will be asked to discuss these ten strategies and other strategies that have worked for them. For homework, participants will be asked to complete three tasks: They will 1) identify a specific academic challenge they face over the course of the following week, 2) employ one strategy from the ten discussed in this session against the challenge, and 3) reflect on whether their learning improved as a result of using the new strategy. In session three, the group leader will introduce the concept of time management and lead a discussion about the four steps to time management. For homework, participants will be asked to track and write down how they spend their time. In session four, group leaders will introduce the five-step study cycle and discuss it with the students. Finally, group leaders will lead a discussion about how participants can continue practicing skills they have learnt in the future. Groups are led by group leaders trained on the study-skills protocol for 10 hours. There will be 6 study-skills groups with 6 group-leaders per school. 288 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants must be aged between 13 and 18. Participants should self-report either elevated symptoms of depression (as indexed by a score of 15 or greater on the PHQ-8) or elevated symptoms of anxiety (as indexed by a score of 10 or greater in the GAD-7). 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. Adolescent: 13 Year-18 Year 13 Year(s) 18 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 11/06/2019 Maseno University Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Private Bag - 40105 Maseno 40105 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 from baseline to 4-week endpoint. Baseline, 2-week midpoint, 4-week endpoint, 2-week follow-up
Primary Outcome Changes in self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener - 7 from baseline to 4-week endpoint. Baseline, 2-week midpoint, 4-week endpoint, 2-week follow-up
Secondary Outcome Changes in perceived academic control from baseline to 2-week follow-up, measured by the Perceived Control Scale for Children - Academic sub scale. Baseline, 4-week endpoint, 2-week follow-up
Secondary Outcome Changes in perceived social control from baseline to 2-week follow-up, measured by the Perceived Control Scale for Children - Social sub scale. Baseline, 2-week midpoint, 4-week endpoint, 2-week follow-up
Secondary Outcome Changes in perceived social support from baseline to 2-week follow-up, as measured by the Multidimensional Scale of Perceived Social Support Baseline, 4-week endpoint, 2-week follow-up
Secondary Outcome Changes in self-reported loneliness from baseline to 2-week follow-up, as measured by UCLA Loneliness Scale – Shortened 8-item Version. Baseline, 2-week follow-up
Secondary Outcome Changes in self-reported optimism from baseline to 2-week follow-up, as measured by the EPOCH Measure of Adolescent Well-Being - Optimism sub scale Baseline, 4-week endpoint, 2-week follow-up
Secondary Outcome Changes in self-reported happiness from baseline to 2-week follow-up, as measured by the EPOCH Measure of Adolescent Well-Being - Happiness sub-scale from baseline to 2-week follow-up. 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 4-item version of the Gratitude Questionnaire. Baseline, 4-week endpoint, 2-week follow-up
Secondary 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 2019, School-term during participation - Term 2 2019, School-term after participation - Term 3 2019
Secondary Outcome Changes in Math and Science Score from school-term before participation to school-term after participation. This will be measured as the average of participant math, biology, chemistry and physics grades. 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 2019, School-term during participation - Term 2 2019, School-term after participation - Term 3 2019
Secondary Outcome Changes in Humanities and Languages Score from school-term before participation to school-term after participation. This will be measured as the average of participant English, Kiswahili, history, geography and religious studies grades. 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 2019, School-term during participation - Term 2 2019, School-term after participation - Term 3 2019
Secondary Outcome A feedback scale will be used to collect acceptability and feasibility data from participants. The youths will be asked questions on the usefulness of the program, whether they understood the contents of the program, whether they would recommend the program to a friend, the most and least helpful elements of the program, and their overall experience. They will also have the option to recommend changes to improve the program for future participants. 4-week endpoint
Secondary Outcome Changes in depressive symptoms from baseline to 2-week follow-up. Baseline, 2-week midpoint, 4-week endpoint, 2-week follow-up
Secondary Outcome Changes in self-reported anxiety symptoms from baseline to 2-week follow-up Baseline, 2-week midpoint, 4-week endpoint, 2-week follow-up
Secondary Outcome Changes in self-reported perceived academic performance from baseline to 4-week endpoint. Baseline, 4-week endpoint.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alliance High School Near Eye Hospital, Kikuyu Kikuyu Kenya
Alliance Girls High School Kikuyu Town Kikuyu Kenya
Kanjeru Girls High School Muguga Location Kikuyu Kenya
Riara Secondary School P.O. Box 412 Kiambu Ndumberi 00900 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Shamiri Institute 82 Wendell Street Pittsfield United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tom Osborn 12A Elgeyo Marakwet Road Nairobi Kenya Individual
Primary Sponsor Shamiri Institute 82 Wendell St. STE 100 Pittsfield United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Katherine Venturo Conerly 80 Colleen Circle Ewing 08638 United States of America
Rediet Alemu P.O.Box 55519 Addis Ababa Ethiopia
Micaela Rodriguez 418 7th Avenue Apt. 3 Brooklyn 11215 United States of America
Elizabeth Roe 269 Prospect Street Belmont 02478 United States of America
Jenny Gan 5336 Wilshire Park Drive Hudson 44236 United States of America
Tomasz Cienkowski 32 Mill Street Cambridge United States of America
Susana Arango Calle 20 c sur 15 - 02, int.104 Medellin Colombia
Akash Wasil 34 Turnberry Court New York United States of America
John Weisz 33 Kirkland Street Cambridge United States of America
Christine Wasanga P.O.Box 43844 00100 Nairobi Kenya
Jessica Schleider Psychology B-340 New York United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tom Osborn osborn@shamiri.institute +254756121145 12A Elgeyo Marakwet Road
City Postal code Country Position/Affiliation
Nairobi Kenya Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Katherine VenturoConerly venturoconerly@shamiri.institute +16099540542 80 Colleen Circle
City Postal code Country Position/Affiliation
Ewing 08638 United States of America Co Investigator
Role Name Email Phone Street address
Public Enquiries Tom Osborn tomleeosborn@gmail.com +25475612145 12A Elgeyo Marakwet Road
City Postal code Country Position/Affiliation
Nairobi Kenya Principal Investigator
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 data will be open. Anyone who wishes to access the data for any purpose will be able to. Data will be made available indefinitely at the link listed under the URL.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://osf.io/ktw25/?view_only=b2c06a2829d7429ba0908fcfaf70cf25 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
Intervention Intervention List 20/06/2019 Trial reviewer notified that group size should be the total size of the group that will receive the intervention (i.e. all the participants that will be assigned to the intervention) and not the size of the peer-led group Experimental Group, Shamiri Intervention Group, 60 minutes, once a week, 4 weeks, The Shamiri intervention consists of three modules: a growth module lasting two sessions; a gratitude module lasting one session; and a virtues or value affirmations module lasting one session. In session one, participants learn about growth and personal improvement. Then, participants read an article and watch a video that describe the concepts of brain neuroplasticity and growth mindset. After this, the group reads testimonials about growth mindsets from well-known figures and hear their group leader’s testimonial. For homework, participants are asked to write about how they use growth to solve a problem. In session two, participants brainstorm and discuss effective strategies that they can use to apply the lessons of growth-mindset in their own lives. They then talk about problem-solving skills in a discussion moderated by the group-leader. After this, they write a letter to a friend in which they explain all the concepts that they have learnt thus far. For homework, participants are asked to think of a problem that is affecting them and employ a specific strategy learned in this session. In session three, students learn about gratitude. The group discusses gratitude and the things for which participants are grateful. Then, participants write a “gratitude letter” to someone who has changed their lives for the better. For homework, participants will have until the next session to identify and reflect on three things that happened each day. In session four, participants learn about virtues and complete a value affirmation exercise. Students are then asked to select, from a list, several values that are important to them. Additionally, they will write in more detail about the one value that they feel is most important to them, describing why this value is important and a time in which they have lived up to that value. Groups are led by group leaders trained on the Shamiri protocol for 10 hours. There will be 6 Shamiri groups with 6 group-leaders per site (school), 12, Experimental Group, Shamiri Intervention Group, 60 minutes, once a week, 4 weeks, The Shamiri intervention consists of three modules: a growth module lasting two sessions; a gratitude module lasting one session; and a virtues or value affirmations module lasting one session. In session one, participants learn about growth and personal improvement. Then, participants read an article and watch a video that describe the concepts of brain neuroplasticity and growth mindset. After this, the group reads testimonials about growth mindsets from well-known figures and hear their group leader’s testimonial. For homework, participants are asked to write about how they use growth to solve a problem. In session two, participants brainstorm and discuss effective strategies that they can use to apply the lessons of growth-mindset in their own lives. They then talk about problem-solving skills in a discussion moderated by the group-leader. After this, they write a letter to a friend in which they explain all the concepts that they have learnt thus far. For homework, participants are asked to think of a problem that is affecting them and employ a specific strategy learned in this session. In session three, students learn about gratitude. The group discusses gratitude and the things for which participants are grateful. Then, participants write a “gratitude letter” to someone who has changed their lives for the better. For homework, participants will have until the next session to identify and reflect on three things that happened each day. In session four, participants learn about virtues and complete a value affirmation exercise. Students are then asked to select, from a list, several values that are important to them. Additionally, they will write in more detail about the one value that they feel is most important to them, describing why this value is important and a time in which they have lived up to that value. Groups are led by group leaders trained on the Shamiri protocol for 10 hours. There will be 6 Shamiri groups with 6 group-leaders per site (school), 288,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/06/2019 The reviewer notified study team that total group size refers to all the participants who will be assigned to the control group, and not the size of the peer-led group Control Group, Study Skills , 60-minute sessions per week, 4 weeks, To control for non-specific aspects of the intervention, the study skills control group will mirror the structure of the Shamiri intervention. Each condition contains the same number of exercises and group discussions, within-session activities are similar in format , and take-home assignments require similar effort. To begin session one, group leaders will offer a didactic introduction of the 5Rs of note-taking. Then, participants will read a short article and complete an exercise to practice the new note-taking method. For homework, participants will be asked to complete three tasks: They will 1) identify one particular class during which they use the 5Rs of note-taking, 2) describe how they used the 5Rs to take notes, and 3) reflect on whether their learning improved as a result of using the new note-taking strategy. During session two, group leaders will first introduce ten effective study strategies. Participants will be asked to discuss these ten strategies and other strategies that have worked for them. For homework, participants will be asked to complete three tasks: They will 1) identify a specific academic challenge they face over the course of the following week, 2) employ one strategy from the ten discussed in this session against the challenge, and 3) reflect on whether their learning improved as a result of using the new strategy. In session three, the group leader will introduce the concept of time management and lead a discussion about the four steps to time management. For homework, participants will be asked to track and write down how they spend their time. In session four, group leaders will introduce the five-step study cycle and discuss it with the students. Finally, group leaders will lead a discussion about how participants can continue practicing skills they have learnt in the future. Groups are led by group leaders trained on the study-skills protocol for 10 hours. There will be 6 study-skills groups with 6 group-leaders per school., 12, Active-Treatment of Control Group Control Group, Study Skills , 60-minute sessions per week, 4 weeks, To control for non-specific aspects of the intervention, the study skills control group will mirror the structure of the Shamiri intervention. Each condition contains the same number of exercises and group discussions, within-session activities are similar in format , and take-home assignments require similar effort. To begin session one, group leaders will offer a didactic introduction of the 5Rs of note-taking. Then, participants will read a short article and complete an exercise to practice the new note-taking method. For homework, participants will be asked to complete three tasks: They will 1) identify one particular class during which they use the 5Rs of note-taking, 2) describe how they used the 5Rs to take notes, and 3) reflect on whether their learning improved as a result of using the new note-taking strategy. During session two, group leaders will first introduce ten effective study strategies. Participants will be asked to discuss these ten strategies and other strategies that have worked for them. For homework, participants will be asked to complete three tasks: They will 1) identify a specific academic challenge they face over the course of the following week, 2) employ one strategy from the ten discussed in this session against the challenge, and 3) reflect on whether their learning improved as a result of using the new strategy. In session three, the group leader will introduce the concept of time management and lead a discussion about the four steps to time management. For homework, participants will be asked to track and write down how they spend their time. In session four, group leaders will introduce the five-step study cycle and discuss it with the students. Finally, group leaders will lead a discussion about how participants can continue practicing skills they have learnt in the future. Groups are led by group leaders trained on the study-skills protocol for 10 hours. There will be 6 study-skills groups with 6 group-leaders per school., 288, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 20/06/2019 Update to indicate the actual trial start date 18 Jun 2019
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 20/06/2019 Update to show that we are now recruiting participants for the trial Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 23/06/2019 Due to scheduling conflicts with the school schedule, the previous school was unable to fit our recruitment and study in the school calendar. Kahuho Uhuru High School, 100 Kikuyu, Kikuyu, , Kenya Kanjeru Girls High School, Muguga Location, Kikuyu, , Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 03/07/2019 Due to changes in the school calendar at previous center that meant we could no longer recruit from the school, we changed recruitment to a different center. Moi Girls Nairobi High School, Jamuhuri, Nairobi, , Kenya Riara Secondary School, P.O. Box 412 Kiambu , Ndumberi, 00900, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 18/07/2019 Updating recruitment status. Recruiting Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 30/07/2019 Reporting final number of recruited participants 420
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 10/09/2019 Updating the final number of participants in the trial 420 413
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 06/04/2020 Updating completing date 28 Feb 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 06/04/2020 Updating recruitment status Closed to recruitment,follow-up continuing Completed