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.: PACTR202208683564666 Date of Approval: 11/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A psychoactive substance use (Pa SU) no foolishness (Ndém) prevention programme among secondary school students (SSS) in Douala-Cameroon.
Official scientific title Impact of health education on the use of psychoactive substance among secondary school students in Douala, A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial When addiction sets in, Psychoactive substance use (PaSU) becomes a source of misery, illness and criminal justice problems. A psychoactive substance is a giant societal monster that affects all ages, races, genders, and professions, and no geolocation is free from it. Although PaSU is mostly individualized, its repercussions are felt mainly at the social level. This trial shall examine the impact of health education on delaying the initiation, and decline of the use of psychoactive substances (PaS), while unveiling the prevalence and current types of psychoactive substance use (PaSU) commonly used by secondary school students (SSS) in the Douala-Cameroon.
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 Education /Training
Anticipated trial start date 11/09/2022
Actual trial start date 18/10/2022
Anticipated date of last follow up 28/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
Recruitment status 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 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 Lessons and gadget group A once-weekly health awareness educative package 06 months We shall conduct a double screening that is a pre and a post-screening on the types and frequency of psychoactive substances commonly used by participants at the beginning and the end of the intervention and expose the participants to an educative package comprising of 05 modules on health awareness with regard to Psychoactive Substance Use. The 05 modules package shall be entitled the: Psychoactive substance no Ndém lessons. It shall be administered alongside the Psychoactive Substances Use Mindful Recalling Relevant Outcomes (Pa SU MIRRO) gadgets 240
Control Group poster group A once-weekly awareness education chat on gambling 06 months We shall conduct a double screening that is a pre-and post-screening on the types and frequency of psychoactive substances commonly used by the participants at baseline and at follow-up to the participants on posters providing anti-gambling information and why gambling is problematic. 240 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Shall be any secondary school student offering a general or technical form of education aged between 13 to 18 years Enrolled into Form Four / Lowersixth for the Anglophone sub-section or in quatrème / Secondé for the Francophone subsection of education in a Government Bilingual School Most have spent at least two years of continuous studying in the same learning institution. And be a participant who has given a written informed assent. Secondary school students enrolled on learning institutions offering a Monolingual subsection of education Participants younger than 12 years and older than 18 years Any participant in a Government Bilingual school who has not given an informed assent Adolescent: 13 Year-18 Year 12 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 24/06/2022 University of Buea Faculty of Health Sciences institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Buea Buea 00237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Types of psychoactive substances commonly used by secondary school students Baseline
Primary Outcome prevalence of psychoactive substance use among secondary school students Baseline six months
Primary Outcome Increased psychoactive substances proficiency skills and health awareness At four month and Six months
Secondary Outcome improved understanding of misperception and peer pressure strategies Six months
Secondary Outcome Delaying initiation to psychoactive substance use six months
Secondary Outcome Behavioural change and peer educator on psychoactive substance use six month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Government Bilingual High Schools in Douala 1 2 3 4 and Douala 5 subdivisions Douala Douala 00237 Cameroon
Government Technical High School in Douala 1 2 3 4 and Douala 5 subdivisions Douala Douala 00237 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
TEKUH ACHU Kingsley University of Buea, Faculty of Health Sciences Department of Public Health P.O Box 63 Buea 00237 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor TEKUH ACHU Kingsley Faculty of Health Sciences, University of Buea P.O Box 63 Buea 00237 Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Professor NSAGHA Dickson Shey Faculty of Health Sciences, University of Buea P.O 63 Buea 00237 Cameroon
Professor NJUNDA Anna LONGDOH Faculty of Health Sciences, University of Buea P.O 63 Buea 00237 Cameroon
Associate Professor ASONGALEM Emmanuel Acha Faculty of Health Sciences, University of Buea P.O 63 Buea 00237 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator TEKUH ACHU Kingsley kingsleytekuh@yahoo.co.uk 000237675425774 Faculty of Health Sciences University of Buea
City Postal code Country Position/Affiliation
Buea 00237 Cameroon PhD candidate in Public Health Faculty of Health Sciences University of Buea
Role Name Email Phone Street address
Public Enquiries TEKUH ACHU Kingsley kingsleytekuh@yahoo.co.uk 00237675425774 Faculty of Health Sciences, University of Buea
City Postal code Country Position/Affiliation
Buea 00237 Cameroon PhD Candidate in Public Health Faculty of Health Sciences University of Buea
Role Name Email Phone Street address
Scientific Enquiries NSAGHA Dickson SHEY dsnsagha@gmail.com 00237677499429 Faculty of Health Sciences University of Buea P.O Box 63
City Postal code Country Position/Affiliation
Buea 00237 Cameroon Main supervisor Professor of Epidemiology and Vice Dean Faculty of Health Sciences University of Buea
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No individual patient data shall be shared during the trial Informed Consent Form,Statistical Analysis Plan,Study Protocol Not applicable Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not applicable for now 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