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.: PACTR201906667800993 Date of Approval: 25/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Single-Session Universal Shamiri Wellness Program
Official scientific title The Shamiri Single-Session Group Intervention for Adolescent Anxiety and Depression: A Randomized Controlled Trial of a Lay Counselor-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 notable 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 depression and anxiety in adolescents in Kenya. The Shamiri intervention protocol draws upon evidence-based components of brief scalable interventions that involve non-clinical psychological principles (rather than principles traditionally used in clinical therapies). The specific components of the original Shamiri Intervention are growth-mindset, gratitude, and virtues or value affirmations. This trial tests each of these components against each other, as well as against a study-skills control group. This new four-group design is aimed to disentangle the effects of each of the three "sections" in the pilot Shamiri intervention conducted during the summer of 2018, and ultimately investigate whether some modules provide greater therapeutic benefit than others. Therefore, there will be four one-hour single-session arms of the intervention: growth mindset, gratitude, value affirmations (virtues), and study skills control.
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 26/06/2019
Actual trial start date
Anticipated date of last follow up 31/07/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 2025
Actual target sample size (number of participants) 895
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
U111112352168 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 Simple randomization using a randomization table created by a computer software program 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 Single Session Intervention Growth Mindset Once 60 minutes In the growth mindset session, participants learn about growth and personal improvement. To begin the session, group leaders will complete brief introductions and set norms. Then, group leaders describe the concept of growth and show a short video that describe the concepts of brain neuroplasticity and growth mindset. They then lead a short discussion on growth and neuroplasticity. After this, the group reads a testimonial about growth from a successful local figure and hears their group leader’s testimonial. Next, participants brainstorm and discuss effective strategies that they can use to apply the lessons of growth­mindset in their own lives. They then talk about problem­solving skills in an informative discussion moderated by the group­leader. After this, they write a letter to a friend in which they explain all the concepts that they have learned thus far. As a take-home activity, participants are encouraged to fill out and act on the problem-solving sheet for a problem they are facing. The number of groups will depend on the number of classes at each school; There will be between 4 and 12 classes at each school, with a group leader randomly assigned to each class. 506
Experimental Group Shamiri Single Session Intervention Gratitude Once 60 minutes In the gratitude session, the group discusses gratitude and the things for which participants are grateful. To begin the session, group leaders will complete brief introductions and set norms. Then, the group leaders describe gratitude and its benefits, and show a short video on the same. Next, the group discusses what gratitude means to them and they list and discuss some things for which they are grateful. Then, participants write a “gratitude letter” to someone who has changed their lives for the better. For a take-home activity, participants will be encouraged to identify and reflect on three good things that happened each day. The number of groups will depend on the number of classes at each school; There will be between 4 and 12 classes at each school, with a group leader randomly assigned to each class. 506
Experimental Group Shamiri Single Session Intervention Virtues Once 60 minutes In the value affirmations session, participants learn about values, which are described as good characteristics (virtues) that are important to you personally, and they complete a value affirmation exercise. To begin the session, group leaders will complete brief introductions and set norms. Then, the group leaders will describe values, show a short video on values, and share a testimonial about someone who especially exemplifies how having and acting on a certain value can improve happiness and success in life. The students will discuss other personal role models, the values they held, and how these values influenced their lives. 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. The activity also asks them to set an achievable, short-term goal based on that value. As a take-home activity, the participants will be encouraged to act on that goal in the upcoming week or two. The number of groups will depend on the number of classes at each school; There will be between 4 and 12 classes at each school, with a group leader randomly assigned to each class. 506
Control Group Shamiri Single Session Intervention Study Skills Once 60 minutes To control for non­specific aspects of the intervention, the study skills control group will mirror the structure of the Shamiri intervention. The condition contains similarly formatted exercises and group discussions, and offers a take-home activity, as in the intervention conditions. To begin the session, group leaders will complete brief introductions and set norms. Then, they will introduce ten effective study strategies. Then, participants will be asked to list some of their own study strategies. Participants will be asked to discuss these ten strategies and other strategies that have worked for them. Finally, they will be asked to discuss how they can apply these strategies in their daily academic life. 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 a strategy or strategies from those discussed in this session against the challenge, and 3) reflect on whether their learning improved as a result of using the new strategy. The number of groups will depend on the number of classes at each school; There will be between 4 and 12 classes at each school, with a group leader randomly assigned to each class. 506 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any student at a participating school who is willing to take part in the program is allowed to do so. There is no exclusion criteria for any participant who meets the inclusion criteria. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 13 Year(s) 19 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 2-week follow-up. Separate comparisons will be made between study skills and each of the three intervention conditions - growth, gratitude, and values. Additionally, the three intervention conditions will be compared to each other to determine their relative effects. Baseline, 2-week follow-up
Primary Outcome Changes in self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener - 7 from baseline to 2-week follow-up. Separate comparisons will be made between study skills and each of the three intervention conditions - growth, gratitude, and values. Additionally, the three intervention conditions will be compared to each other to determine their relative effects. Baseline, 2-week follow-up
Primary Outcome Changes in self-reported happiness, as measured by the EPOCH Measure of Adolescent Well-Being - Happiness subscale. Separate comparisons will be made between study skills and each of the three intervention conditions - growth, gratitude, and values. Additionally, the three intervention conditions will be compared to each other to determine their relative effects. Baseline, 2-week follow-up
Secondary Outcome Changes in self-reported depression symptoms as measured by the PHQ-8 for participants who meet a clinical cut-off for depression and anxiety symptoms - clinical cutoff will be determined by a score of 10 or greater on the GAD-7 or a score of 15 or greater on the PHQ-8. Separate comparisons will be made between study skills and each of the three intervention conditions - growth, gratitude, and values. Additionally, the three intervention conditions will be compared to each other to determine their relative effects. Baseline, 2-week follow-up
Secondary Outcome Changes in self-reported anxiety symptoms as measured by the GAD-7 for participants who meet a clinical cut-off for depression and anxiety symptoms - clinical cutoff will be determined by a score of 10 or greater on the GAD-7 or a score of 15 or greater on the PHQ-8. Separate comparisons will be made between study skills and each of the three intervention conditions - growth, gratitude, and values. Additionally, the three intervention conditions will be compared to each other to determine their relative effects. Baseline, 2-week follow-up
Secondary Outcome Moderator analysis on primary outcomes with level of anxiety symptoms as a continuous moderator. Separate comparisons will be made between study skills and each of the three intervention conditions - growth, gratitude, and values. Additionally, the three intervention conditions will be compared to each other to determine their relative effects. Baseline, 2-week follow-up
Secondary Outcome Moderator analysis on primary outcomes with level of depression symptoms as a continuous moderator. Separate comparisons will be made between study skills and each of the three intervention conditions - growth, gratitude, and values. Additionally, the three intervention conditions will be compared to each other to determine their relative effects. Baseline, 2-week follow-up
Secondary Outcome Moderator analysis on primary outcomes with level of anxiety symptoms as a categorical moderator - categories will be no-anxiety, 0-4 on GAD-7, mild-anxiety, 5-9 on the GAD-7, and moderate-to-severe anxiety, 10 or greater on the GAD - 7. Separate comparisons will be made between study skills and each of the three intervention conditions - growth, gratitude, and values. Additionally, the three intervention conditions will be compared to each other to determine their relative effects. Baseline, 2-week follow-up
Secondary Outcome Moderator analysis on primary outcomes with level of depression symptoms as a categorical moderator - categories will be defined as minimal-or-none depression, defined as 0-4 on the PHQ-8, mild depression, defined as 5-9 on the PHQ-8, moderate depression, defined as 10-14 on the PHQ-8, moderately severe-to-severe depression, defined as greater than 15 on the PHQ-8. Separate comparisons will be made between study skills and each of the three intervention conditions - growth, gratitude, and values. Additionally, the three intervention conditions will be compared to each other to determine their relative effects. Baseline, 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 overall, in math and science, and in humanities and languages, 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. Separate comparisons will be made between study skills and each of the three intervention conditions - growth, gratitude, and values. Additionally, the three intervention conditions will be compared to each other to determine their relative effects. 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. Immediately post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kikuyu Day High School Hospital Road Kikuyu Kenya
Thika Girls High School Thika Mangu Road Thika 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 LLC 82 Wendell St Pittsfield United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Elizabeth Roe 101 Dunster Street Cambridge United States of America
Rediet Alemu P.O.Box 55519 Addis Ababa Ethiopia
Katherine Venturo Conerly 80 Colleen Circle Ewing United States of America
Micaela Rodriguez 26 Plympton Street Cambridge United States of America
Jenny Gan 28 Dewolfe 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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tom Osborn tomleeosborn@gmail.com +254756121145 12A Elgeyo Marakwet Road
City Postal code Country Position/Affiliation
Nairobi Kenya Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Katherine Venturo Conerly venturoconerly@shamiri.institute +16099540542 80 Colleen Street
City Postal code Country Position/Affiliation
Ewing United States of America Co Principal Investigator
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 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
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