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.: PACTR202304629001181 Date of Registration: 28/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Shamiri Mindfulness-Based Intervention
Official scientific title Testing a Mindfulness-Based Intervention on Adolescent Wellbeing and Academic Performance among Kenyan Secondary School Students
Brief summary describing the background and objectives of the trial Mindfulness is the act of being aware of the present moment, intentionally and without judgment. This includes being mindful of one’s immediate environment, in addition to one’s thoughts, emotions and behaviors. Recently, mindfulness-based interventions (MBI) have gained momentum in the research space and have been proven to improve participants’ mental wellbeing in various ways. Accordingly, the Shamiri team has identified a school based MBI as one potential and innovative tool to improve youth mental health in Kenya. The team has significantly adapted the content of an existing MBI -named Learn to BREATHE- to fit a Kenyan context. The content of the newly designed MBI will focus on learning about and practicing mindfulness of one’s environment, thoughts, emotions, and behaviors. This intervention will be delivered by lay-providers to small groups of secondary school students in weekly 1-hour sessions, for four weeks. The study is a two arm randomized control trial, with a waitlist control group. The estimated sample size is 400 participants, with 200 students in the active intervention group, and 200 students in the waitlist control group.The primary hypothesis is that this intervention will lead to a reduction of anxiety and depression symptoms in addition to improvements in mindfulness skills amongst participants. Additionally, the Shamiri team hypothesizes that this intervention can improve participants’ mental wellbeing, quality of life and emotion regulation, in addition to their academic performances.
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 04/07/2022
Actual trial start date 26/06/2023
Anticipated date of last follow up 30/09/2023
Actual Last follow-up date 30/09/2023
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 510
Recruitment status Completed
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 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 Mindfulness Based Intervention 60-minute sessions per week 4 weeks The intervention will be delivered by lay providers in 4 sessions per week. The goal of the first session is to introduce the participants to the concept and practice of mindfulness with a focus on mindfulness of the body. This will be aided by the use of a mindful listening activity, mindful observation, and a simple body scan. The second session will explore how thoughts and emotions work and practice how to reduce the negative impact of repetitive unpleasant thoughts and regulate emotions by practicing mindfulness. The fellow will highlight the correlation between repetitive unpleasant thoughts and stress followed by a discussion on common stressors. The third session will explore different stressors in one’s life, how to utilize mindfulness when faced with stressors, and foster an intentional practice of kindness. This session will also engage participants in a gratitude activity as well as an activity where they will write well wishes for each other. The fourth and final session will encourage students to continue practicing mindfulness and to reflect on and summarize the content of the previous sessions. All sessions begin with a mindfulness activity guided by the fellow, a summary of the previous session, and end with a summary of the session and a homework activity. 200
Control Group Waitlist None 4 weeks The waitlist control groups will meet during the first week. The goal of this session is for the fellow to explain the purpose and procedures of the waitlist control group. Participants will be informed that they are to meet again during the fourth week and during the one-month data collection point, to complete the respective questionnaires. The fellow will also inform participants that after one-month data collection, they will be randomized into smaller groups and will receive the Single Session Shamiri MBI, in addition to the program booklet. 200 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The Shamiri team will sample schools to be used in this study based on accessibility and suitability of the schools. All willing and consenting participants aged 14-21 enrolled in the selected high schools will be eligible to participate in the study. For each school, the first ~140 interested students will be eligible to participate in the study. No other inclusion or exclusion criteria will be applied except on basis of capacity. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 14 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 20/06/2023 Kenyatta University Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Thika Road Nairobi 43844 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 Baseline, 2-week midpoint, 4-week endpoint, 1-month
Primary Outcome Self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener-7 Baseline, 2-week midpoint, 4-week endpoint and 1 month
Primary Outcome Mindfulness, measured as the individual differences in frequency of mindful state over time. Baseline, 2-week midpoint, 4-week endpoint and one-month follow up
Secondary 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 and 1 month,
Secondary Outcome Changes in emotional regulation, measured as a persons ability to manage and respond to emotional experiences, using the Emotion Regulation Questionnaire ERQ. Baseline, 2-week midpoint, 4-week endpoint and 1 month follow up
Secondary Outcome Youth quality of life, measured by the Youth Quality of Life Scale-Short Form YQOLS-SF Baseline, 2-week midpoint, 4-week endpoint and 1 month follow up
Secondary Outcome Satisfaction with life, measured by the Satisfaction with Life Scale SWLS. Baseline, 2-week midpoint, 4-week endpoint and1 month follow up
Secondary Outcome Changes in academic performance, measured by publicly available academic records of grades and scores. School terms before, during and after the intervention
Secondary Outcome Program evaluation and feedback, including questions about the intervention 4-week endpoint and 1 month follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shamiri Institute Chania Avenue, Kilimani Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Shamiri Institute Chania Avenue, Kilimani Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shamiri Institute Chania Avenue, Kilimani Nairobi Kenya Self-sponsored
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tom Osborn osborn@shamiri.institute +2540112540760 CMS-Africa Pioneer Point Chania Avenue
City Postal code Country Position/Affiliation
Nairobi 00506 Kenya CoFounder and CEO Shamiri Institute
Role Name Email Phone Street address
Public Enquiries Hilda Nyareso nyareso@shamiri.institute +254112540760 Chania Avenue
City Postal code Country Position/Affiliation
Nairobi 00506 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 United States of America Shamiri Institute and Harvard University
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