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.: PACTR201906810558181 Date of Approval: 21/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Internet - Based Shamiri Single Session Intervention
Official scientific title The Shamiri Single Session Digital Intervention for Adolescent Anxiety and Depression: A Randomized Control Trial of an Internet - Based Intervention in a Low-resourced School in Kenya
Brief summary describing the background and objectives of the trial Low-cost and scalable interventions for youth depression and anxiety in low-income regions such as countries in Sub Saharan Africa can potentially increase help-seeking options for youths. This is important because the incidence of youth depression and anxiety is on the rise, yet a majority of youths are unable to access needed care. The Shamiri single-session digital intervention is a universal ninety-minute internet-based intervention that draws upon evidence-based components of brief scalable interventions that involve non-clinical psychological principles rather than the treatment of psychopathology. The specific components of the intervention are growth mindset, gratitude, and virtues or value affirmations. Students (approximately N = 130) will be eligible to participate in the intervention, as long as they are interested as this is a universal intervention. The intervention will be delivered on a computer for approximately 90 minutes.
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 21/06/2019
Actual trial start date 29/06/2019
Anticipated date of last follow up 30/09/2019
Actual Last follow-up date 23/07/2019
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants) 103
Recruitment status Completed
Publication URL https://doi.org/10.1037/ccp0000505
Secondary Ids Issuing authority/Trial register
U111112352289 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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Shamiri Digital Intervention Group Once 90 minutes The Shamiri Digital Intervention will be done in a single-session of approximately 90 minutes. It consists of three lessons: growth mindset, gratitude, and virtues, each lasting 15-20 minutes. During the first lesson, participants are presented with a detailed definition of growth, and what it means to grow in various aspects of their lives. This is followed by a simplified explanation of neuroplasticity which emphasizes everyone’s ability to grow and encourages participants to see challenges as opportunities for growth. Then, a growth testimonial from a Kenyan student at Harvard is presented to participants. Participants then complete an activity regarding a time they have faced a challenge. To begin the second lesson, participants are presented with an explanation of gratitude and various ways of expressing it. Participants then complete an activity which requires them to mention three good things that have happened to them recently and enables them to practice expressing their gratitude. To begin the third lesson, participants are presented with an explanation of virtues and a list of virtues. Participants are then required to choose a virtue that is the most important to them and write about it. 65
Control Group Shamiri Digital Study Skills Once 90 minutes. The study-skills intervention will be done in a single-session of approximately 90 minutes. It has four lessons: note-taking, effective study strategies, time management skills and the study cycle. In the first lesson, students learn effective note taking strategies called the 5Rs of note-taking and do a simple note-taking exercise, in lesson two students learn about effective study strategies, in lesson three students learn time managements skills and do a simple time-management exercise, and finally students learn about the study cycle that ties together all the other lessons that they learnt earlier. 65 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. There is no exclusion criteria for any participant who meets the inclusion criteria. 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
Maseno University Main Campus, Along Kisumu-Busia Road 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 Baseline and 2-week follow-up.
Primary Outcome Changes in self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener - 7 Baseline and 2-week follow-up
Secondary Outcome Changes in perceived academic control, measured by the Perceived Control Scale for Children - Academic sub scale. Baseline and 2-week follow-up.
Secondary Outcome Changes in self-reported optimism, as measured by the EPOCH Measure of Adolescent Well-Being - Optimism sub scale Baseline and 2-week follow-up.
Secondary Outcome Changes in self-reported happiness, as measured by the EPOCH Measure of Adolescent Well-Being - Happiness subscale. Baseline and 2-week follow-up.
Primary Outcome Changes in self-reported mental well-being as indicated by the The Short Warwick–Edinburgh Mental Well-being Scale (SWEMWBS) Baseline and 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 Baseline and 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 Baseline and 2-week follow-up.
Secondary Outcome Moderator analysis on primary outcomes with level of anxiety symptoms as a continuous moderator. Baseline and 2-week follow-up.
Secondary Outcome Moderator analysis on primary outcomes with level of depression symptoms as a continuous moderator. Baseline and 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 . Baseline and 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. Baseline and 2-week follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Damacrest Senior School Kikuyu Town Kikuyu 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 Street Pittsfield United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Susana Arango Calle 20 c sur 15 - 02, int.104 Medellin Colombia
Rediet Alemu P.O.Box 55519 Addis Ababa Ethiopia
Elizabeth Roe 269 Prospect Street Belmont 02478 United States of America
Micaela Rodriguez 418 7th Ave Apt. 3 Brooklyn 11215 United States of America
Katherine Venturo Conerly 80 Colleen Circle Ewing 08638 United States of America
Akash Wasil 34 Turnberry Court Dix Hills United States of America
John Weisz 33 Kirkland Street Cambridge United States of America
Christine Wasanga P.O.Box 43844 00100 Nairobi Kenya
Jenny Wang 5336 Wilshire Park Drive Hudson 44236 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 Venturo Conerly venturoconerly@shamiri.institute +16099540542 80 Colleen Street
City Postal code Country Position/Affiliation
Cambridge United States of America Co Investigator
Role Name Email Phone Street address
Public Enquiries Tom Osborn osborn@shamiri.institute +25475612145 12A Elgeyo Marakwet Road
City Postal code Country Position/Affiliation
Nairobi Kenya Principal Investigator
Role Name Email Phone Street address
Public Enquiries Rediet Alemu rediet@shamiri.institute +251923590095 P.O. Box 55519
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Co 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 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 a link to be posted upon trial completion.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://osf.io/jyvux/ Yes Compared to the control, Shamiri-Digital produced greater reduction in adolescent depression symptoms in both the full sample (p = 0.028, d = 0.50) and a sub-sample of youths with moderate-to-severe depression symptoms (p = 0.010, d = 0.83) from baseline to two-week follow-up. The effects exceed the mean effects reported in meta-analyses of full-length, face-to-face psychotherapy for youth depression. There were no significant effects on anxiety symptoms, well-being, or happiness. 05/04/2020 24/03/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://osf.io/jyvux/
Changes to trial information