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.: PACTR202402582772627 Date of Approval: 07/02/2024
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 Addis Abeba, Ethiopia
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. The Shamiri Intervention –originally developed for adolescents in Kenya– targets youth depression and anxiety symptoms. 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 = 560) with elevated depression and/or anxiety symptoms will be randomized into either the Shamiri treatment group or a waitlist control group. The students in the treatment group 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. The students in the waitlist group will meet for data collection, and they will receive the Single Session Shamiri Intervention after one-month follow-up data has been collected. This study has two primary objectives. The first is to evaluate the efficacy of the Shamiri intervention for depression and anxiety for youths in Addis Abeba, Ethiopia. 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 the present study are youth depression and anxiety symptoms. The secondary outcomes measures are perceived social support, gratitude and academic performance.
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 19/03/2024
Actual trial start date
Anticipated date of last follow up 28/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 560
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Shamiri Intervention Once a week for four weeks Four 1-hour sessions 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 and hear their group leader’s testimonial. For homework, participants are asked to write about how they use growth mindset 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 good 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 7 Shamiri groups with 7 group-leaders per site (school) 280
Control Group Single Session Shamiri Intervention Once a week, for one week One 1-hour session The participants in the waitlist control group will briefly meet for completing questionnaires throughout the four weeks (during which intervention group participants will receive the four-week Shamiri Intervention). They will also participate in the one-month follow-up data collection. After data collection is complete, they will be randomly allocated to groups of 10-15 and assigned a group leader. Their groups will meet for a single 60-minute session during which the group leader will deliver the Single Session Shamiri Intervention (Values). This session mirrors the fourth session of the four-week Shamiri Intervention. In this session, 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. This single session intervention was selected since it had the most significant impact on Kenyan participants' depressive and anxiety symptoms, relative to single session intervention based on the remaining modules in the Shamiri Intervention. 280 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 and enrolled in the schools in which we will implement the intervention. 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 03/01/2024 Ethiopian Society of Sociologists Social Workers and Anthropologists
Ethics Committee Address
Street address City Postal code Country
4 Kilo Area, Holy Trinity College, 5th Floor, Office No. 502 Addis Abeba 1000 Ethiopia
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, one-month 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, one-month follow-up
Secondary Outcome Changes in perceived social support from baseline to 4-week endpoint, as measured by the Multidimensional Scale of Perceived Social Support Baseline, 4-week endpoint, one-month follow-up
Secondary Outcome Changes in self-reported Gratitude from baseline to 4-week endpoint, as measured by the Gratitude Questionnaire. Baseline, 4-week endpoint, one-month follow-up
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 self-reported responses to previous traumatic events, measured by the Child and Adolescent Trauma Screen questionnaire. Baseline, 4-week endpoint, one-month follow-up
Secondary Outcome Changes in self-reported wellbeing, measured by the short version of the Warwick–Edinburgh Mental Wellbeing Scale (WEMWBS). Baseline, 2-week midpoint, 4-week endpoint, one-month follow-up
Secondary Outcome Academic performance, measured by school transcripts Transcripts from semester ending before implementation, transcripts from semester ending after implementation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dr. Haddis Alemayehu General Secondary School Micky Leland Street Addis Abeba Ethiopia
Bole General Secondary School Djibouti Street Addis Abeba Ethiopia
Bole Community Secondary School Bole Homes Area Addis Abeba Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Shamiri Institute Pioneer Point, Chania Avenue Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shamiri Institute 13th Floor, Pioneer Point, Chania Avenue Nairobi Kenya Research Institute
COLLABORATORS
Name Street address City Postal code Country
Rediet Getnet Alemu Mickey Le Land Street Addis Abeba Ethiopia
Liyou Libsekal Mickey Le Land Street Addis Abeba Ethiopia
Bethelhem Sileshi Dejene Mickey Le Land Street Addis Abeba Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ephrem Woldeyesus ephremwill@gmail.com +251913513702 Mickey Leland Street
City Postal code Country Position/Affiliation
Addis Abeba Ethiopia SunEko Art for Social Development
Role Name Email Phone Street address
Scientific Enquiries Rediet Alemu rediet.alemu@shamiri.institute +251923590095 Mickey Leland Street
City Postal code Country Position/Affiliation
Addis Abeba Ethiopia Shamiri Institute
Role Name Email Phone Street address
Public Enquiries Liyou Libsekal liyou.libsekal@shamiri.institute +251911337928 Mickey Leland Street
City Postal code Country Position/Affiliation
Addis Abeba Ethiopia SunEko Art for Social Development
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected throughout implementation which will have been de-identified Analytic Code,Informed Consent Form,Statistical Analysis Plan Beginning 3 months and ending 3 years following article publication. Access to data will be open for anyone who wishes to access it.
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