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.: PACTR202111497122432 Date of Approval: 10/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Pre-Texts Intervention for Youth Mental Health and Wellbeing in Kenya
Official scientific title Pre-Texts: An Arts-Based Intervention to Improve Health Outcomes Among School-Going Adolescents in Kenya
Brief summary describing the background and objectives of the trial Depression and anxiety account for 45% of the global burden of disease for young people aged 12-to-21. Adolescents living in low-income settings – such as Kibera slum in Kenya – are most affected. For these youths, treatments are scarce, inaccessible, or stigmatized. Here, we will test whether Pre-Texts, an art-based non-clinical intervention that combines elements of arts-based pedagogies and psychological science, can reduce adolescent depression and anxiety symptoms as well as improve literacy, citizenship, innovation and overall wellbeing.
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 08/11/2021
Actual trial start date
Anticipated date of last follow up 31/05/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 235
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
Crossover: all participants receive all interventions in different sequence 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 PreTexts 60-minute sessions per day 4 days Pre-Texts is a creative arts-based intervention. Participants are asked to "Make art from this text and reflect on the process." Pre-Texts stimulates a holistic cluster of development and development (cognitive, emotional, and social). Participants take up the challenge, not necessarily because they want to read but because they are invited to make art and to talk about their work. Facilitators distribute paper or used cardboard and pencils, crayons, markers. The first activity combines listening and drawing It engages faculties without soliciting correct answers or beautiful results. The general objective is to enhance curiosity and self-esteem and the method is to recognize each person as a creative artist and intellectual.Someone reads a text aloud while the rest draw book covers for personal editions. The scene borrows from two Latin American practices: One is the professional “lector” in tobacco factories who reads aloud from a literary, historical, or philosophical text that the workers have selected to hear as they roll cigars. The other practice is making artisanal books from used cardboard and classic or contemporary texts. We begin this way because facilitators assume that most students don’t like to read, so instead of rereading a text in a remedial session, one on one after school, a volunteer student reads aloud to groups of student artists as they make art. After this, each participant asks a question of the text, aloud. Tutors don’t ask questions of students. Students are not objects of scrutiny; they are investigators who scrutinize a text. Artists are not victims but decision-makers. Most teenagers will not have paid much attention to the text while drawing, so participants are relieved to find available copies they actually want to read in order to formulate a presentable question. Very soon, practically everyone is busy deciphering the text in order to pull out a question. This introductory activity ends a reflection on “What did we do?" 150
Control Group Study skills 60-minute sessions per day 4 days The study skills control intervention, like the other active interventions, lasts for four hours spread across four weeks. It is an active control intervention designed to control for all the non-specific aspects of group psychotherapy including meeting in a group of students with a trained lay-provider once a week, having discussions, completing activities in-session, and completing homework assignments. Additionally, because students in Kenya suffer at high rates of depression and anxiety symptoms from undue family, school, and peer-induced pressure to succeed academically, there is good reason to believe that this study-skills control intervention will somewhat alleviate symptoms of mental health problems. Previous trials using a study skills control arm in this population support the fact that it has some effects on mental health problems. This study skills control intervention includes exercises and group discussions about study strategies to improve academic performance, with a particular focus on note-taking and the cycle of studying activities (e.g., previewing content, self-assessment). Within-session activities include reading a short article to practice note-taking strategies, sharing in pairs their understanding of the strategies discussed, and discussing the content and its applications as a large group. Between-session take-home assignments include filling out worksheets that enable the participants to further practice the study skills and reflect on whether their learning improved as a result of the skills. 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All students aged between 13 to 18 years —who consent—will be eligible to participate and no other exclusion criteria will be applied. No further exclusion criteria will be applied. Adolescent: 13 Year-18 Year 12 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 30/07/2021 Maseno University Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Along Kisumu-Busia Road Maseno N/A Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assess youth depression symptoms and severity using the Patient Health Questionnaire-8, or PHQ-8. Baseline, endpoint, and 1-month follow up
Primary Outcome Assess anxiety disorder symptoms and severity based on the Generalized Anxiety Disorder Screener-7, or GAD-7. Baseline, endpoint, and 1-month follow up
Secondary Outcome Academic performance changes, based on public academic records of grades and scores. School term prior to the intervention and post-intervention school term
Secondary Outcome Changes in perceived control measured by the Perceived Control Scale for Children, or PCS. Baseline, endpoint, and 1-month follow up
Secondary Outcome Changes in secondary control measured by the Secondary Control Scale for Children Baseline, endpoint, and 1-month follow up
Secondary Outcome Changes in the adolescent wellbeing scale as measured by the EPOCH Measure of Adolescent Well-Being. Baseline, endpoint, and 1-month follow up
Secondary Outcome Changes in gratitude as measured by the Gratitude Questionnaire (6 item) Baseline, endpoint, and 1-month follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elite High School Kibera Drive Nairobi 00300 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Harvard University Mind Brain Behavior Interfaculty Initiative William James Hall 1380-1384 33 Kirkland Street Cambridge 02138 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shamiri Institute 115 Applewood Adams, Ngong Road Nairobi 00300 Kenya Charities/Societies/Foundation
Primary Sponsor Tom Osborn 115 Applewood Adams, Ngong Road Nairobi 00300 Kenya Individual
Secondary Sponsor Harvard University Mind Brain Behavior Initiative 33 Kirkland Street Cambridge 02138 United States of America Funding Agency
Secondary Sponsor Cultural Agents Initiative 259 Webster Street Bostone United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr. David M. Ndetei Mawehsi Gardens, Off Matumbato Rd Nairobi Kenya
Dr. Doris Sommer Boylston Hall, 4th Floor, Cambridge, MA 02138 Cambridge United States of America
Africa Mental Health Research and Training Foundation Mawehsi Gardens, Off Matumbato Rd Nairobi Kenya
Cultural Agents INC 259 Webster Street, Suite 1 Boston MA 02128 United States of America
Harvard University Department of Romance Languages and Literatures Harvard Yard Boylston Hall 417 Cambridge MA 02138 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tom Osborn osborn@shamiri.institute +254706408811 115 Applewood Adams, Ngong Road
City Postal code Country Position/Affiliation
Nairobi 00300 Kenya Executive Director
Role Name Email Phone Street address
Public Enquiries Tom Osborn osborn@shamiri.institute +254706408811 115 Applewood Adams, Ngong Road
City Postal code Country Position/Affiliation
Nairobi 00300 Kenya Executive Director
Role Name Email Phone Street address
Scientific Enquiries Tom Osborn osborn@shamiri.institute +254706408811 115 Applewood Adams, Ngong Road
City Postal code Country Position/Affiliation
Nairobi 00300 Kenya Executive Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the 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.
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