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.: PACTR202408747469286 Date of Registration: 14/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Expanding Mental Health Interventions: Scaling Up the Pre-Texts Arts-Literacy Intervention
Official scientific title Expanding Mental Health Interventions for Kenyan Youth: Scaling Up the Pre-Texts Arts-Literacy Intervention 
Brief summary describing the background and objectives of the trial Due to inaccessible mental healthcare services, there is a dearth of appropriate and evidence-based mental health care available to Kenyan adolescents. By consensus, traditional psychotherapy and psychiatric treatments pose structural barriers to adequate care, thus warranting alternative intervention strategies. Recent psychological studies have shown that these options are becoming increasingly productive. Here, we build upon ongoing studies assessing whether Pretext—a non-clinical arts-based group intervention—can 1. improve mental health and well-being (by reducing depression and anxiety symptoms), 2. enhance social and academic functioning, and 3. foster innovation, literacy, and citizenship amongst school-going children in Nairobi and Kiambu counties.
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 01/07/2024
Actual trial start date 01/07/2024
Anticipated date of last follow up 31/03/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 1800
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 1hr/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?" 900
Control Group Treatment as Usual 4 questionnaires over a period of three months 3 months Students  assigned to the treatment as usual condition will be meeting with the study team to complete questionnaires at baseline,1-week endpoint, 1-month and 3-month follow up. They will be notified that they can see an available clinical supervisor for any problem they feel requires their help. As such, a clinical supervisor will be made available for them on a self-referral basis or referred by the study team handling questionnaire administration.  Besides filling in the questionnaires, the students in this group can be let go to receive the usual services the school offers.  900 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primary school students in one of the selected schools from grade 1- 4  High school students in the selected schools from form 1-3 No exclusion criteria will be applied  Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 7 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 24/06/2024 Kenyatta University Centre for Research Ethics and Safety
Ethics Committee Address
Street address City Postal code Country
Kenyatta University Main Campus Thika Road Central Administration Complex Nairobi 00100 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, endpoint,1-month and 3 months follow up
Primary Outcome Changes in self-reported anxiety symptoms, measured by the Generalized Anxiety Disorder Screener  Baseline, endpoint, 1-month and 3 months follow up
Primary Outcome Improvements in innovation measured by the Curiosity and Exploration Inventory Baseline, endpoint, 1-month and 3 months follow up
Primary Outcome Changes in students’ emotions, measured by thematic coded qualitative data on how they feel  Baseline, endpoint, 1-month and 3 months follow up
Primary Outcome Changes in students’ problematic behavior in classrooms as measured by the Problem Behavior Scale responded to by teachers. Baseline, endpoint, 1-month and 3 months follow up
Secondary Outcome Changes in participants’ peer relationships as measured by the Peer Relationships Scale Baseline, endpoint, 1-month and 3 months follow up
Secondary Outcome Changes in school climate, as measured by the School Climate Measure Baseline, endpoint, 1-month and 3 months 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 achieved by students across all enrolled students. School term prior to the intervention and post-intervention school term
Secondary Outcome A feedback scale will be used to assess participant’s feedback about the program  Endpoint
Secondary Outcome Changes in the classroom climate as measured by the Teacher Classroom Climate Scale Baseline, endpoint, 1-month and 3 months follow up
Secondary Outcome Changes in teachers’ self-efficacy in handling a classroom and their job as measured by the Teacher Self-Efficacy Tool Baseline, endpoint, 1-month and 3 months follow up
Secondary Outcome Changes in teachers’ curiosity and exploration as measured by the Curiosity and Exploration Inventory Baseline, endpoint, 1-month and 3 months follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Silver Springs secondary school Sarangombe Nairobi Kenya
Riruta Satellite secondary school Riruta Nairobi Kenya
Ndurarua High school Wangige Nairobi Kenya
Mutuini High school Dagoretti Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Motsepe Presidential Research Accelerator Fund for Africa Harvard University Center for African Studies Cambridge MA 02138 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shamiri Institute CMS-Africa, 13th Floor, Pioneer Point, Chania Avenue Nairobi 00100 Kenya Charities/Societies/Foundation
Secondary Sponsor Motsepe Presidential Research Accelerator Fund for Africa Harvard University Center for African Studies Cambridge MA 02138 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr. Doris Sommer Boylston Hall, 4th Floor Cambridge MA 02138 United States of America
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 CMS-Africa, 13th Floor, Pioneer Point, Chania Avenue
City Postal code Country Position/Affiliation
Nairobi Kenya Executive Director
Role Name Email Phone Street address
Public Enquiries Tom Osborn osborn@shamiri.institute +254706408811 CMS-Africa, 13th Floor, Pioneer Point, Chania Avenue
City Postal code Country Position/Affiliation
Nairobi Kenya Executive Director
Role Name Email Phone Street address
Scientific Enquiries Tom Osborn osborn@shamiri.institute +254706408811 CMS-Africa, 13th Floor, Pioneer Point, Chania Avenue
City Postal code Country Position/Affiliation
Nairobi 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