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.: PACTR202401711272288 Date of Approval: 26/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The "HOPE" school program against the use of psychoactive substances among Moroccan middle school students: Study protocol for a quasi-experimental intervention
Official scientific title The "HOPE" school program against the use of psychoactive substances among Moroccan middle school students: Study protocol for a quasi-experimental intervention
Brief summary describing the background and objectives of the trial Early initiation of psychoactive substance use among adolescents constitutes a major risk for health and social issues. The implementation of school-based prevention programs focusing on the development of psychosocial skills is an essential strategy for effectively delaying, reducing or eliminating the overall risks associated with substance use. This study aims to develop, implement, and evaluate a school-based prevention program named "HOPE", based on enhancing knowledge, attitudes, and psychosocial skills of students in Fez city- Morocco, regarding the use of psychoactive substances and the associated physical and psychological symptoms. A quasi-experimental study with pre- and postintervention measurements will be conducted in 12 middle schools involving first-year middle school students and their parents. A total of 1,000 students will be included with 500 receiving the prevention program, and 500 forming the control group. Additionally, 60 to 90 parents of students in the intervention group will participate in training sessions. Data will be gathered through student questionnaires and parent focus groups.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Substances use
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 31/12/2023
Actual trial start date 15/02/2024
Anticipated date of last follow up 30/06/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants)
Recruitment status Not yet 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 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 Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HOPE program trainning session 15 training sessions 3 years The "HOPE" program is a Moroccan initiative aimed at preventing the use of PAS by reinforcing protective factors and reducing risk factors among middle school students. Its main objectives are to prevent or delay the initiation of PAS, to reduce PAS consumption among current users, and to decrease the physical and psychological effects associated with PAS consumption. Fifteen (15) sessions dedicated to students in the intervention group. During the initial year of program implementation, ten (10) sessions will be scheduled with the aim of raising knowledge of the risks associated with PAS, challenging the normalization of PAS use by evaluating attitudes toward acceptability and negative consequences, and fostering psychosocial skills, in particular interpersonal (communication, group dynamics, social support, and peer influence/pressure), as well as intrapersonal skills (self-esteem, problem-solving, decision-making, stress and emotion management). Five (5) additional consolidation sessions will be provided in the second year of the program according to the needs identified at the end of the first phase, with the aim of strengthening and consolidating the knowledge and skills acquired in the first year. 500
Control Group Hope Program The control group of students will only be monitored over time without receiving any intervention. 3 years The "HOPE" program is a Moroccan initiative aimed at preventing the use of PAS by reinforcing protective factors and reducing risk factors among middle school students. Its main objectives are to prevent or delay the initiation of PAS, to reduce PAS consumption among current users, and to decrease the physical and psychological effects associated with PAS consumption. The 500 participants in the control group will not receive any intervention. They will only be monitored over time. 500 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants will be included if they : - Be aged 12 to 13 at the study's commencement - Enrolled in the first year of middle school - Have acquired informed consent from their parents/guardians, as well as their own consent to participate in the study. - Parents are considered eligible if their children are included in the intervention group, and if they give their informed consent to participate. Participants will be excluded if they : - Have previously taken part in or are currently enrolled in another school-based PAS prevention program - Have declined attendance in all program sessions. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 12 Year(s) 13 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 22/01/2024 Ethics Committee of the Hassan II University Hospital in Fez
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine and Pharmacy of Fez BP.1893 Km2.200 Route de Sidi Hrazem Fez 3600 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The first criterion for evaluating the intervention will be knowledge about PAS (physiological effects, risks and psycho-social consequences), and attitudes (negative/positive) toward PAS. This will be followed by an evaluation of interpersonal skills: communication/resistance to group pressure/belonging and social support skills and self-esteem; and intrapersonal skills: problem-solving and decision-making skills/stress management skills and emotion management skills. End of the intervention period - January 2025
Secondary Outcome The second evaluation criterion for assessing the impact of the "HOPE" program will focus on PAS consumption. This includes examining factors such as the age at which individuals initiate PAS use, the prevalence of use (including substances such as tobacco, cannabis, alcohol, benzodiazepines and inhalants), and any associated behavioral issues. Additionally, the evaluation will center on the physical and psychological manifestations associated with the consumption of psychoactive substances (PAS) in students. This scrutiny will cover aspects like sleep disturbances, aggressive behaviors, depression, anxiety, stress, and the risk of suicide. 18 months after the intervention - June 2026
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nassim middle school Zouagha, Fez Fez 30000 Morocco
Abdelali Benchekroun middle school Mariniyine, Fez Fez 30000 Morocco
El Qods Middle School New City, Fez Fez 30050 Morocco
Hassan Benchekroun Middle School Sais, Fez Fez 30000 Morocco
Mouad Ibn Jaba middle school Oulad Tayeb, Fez Fez 30023 Morocco
Al Maghreb Al Arabi middle school Jnan El Ouard, Fez Fez 30000 Morocco
Al Adarissa middle school Zouagha, Fez Fez 30000 Morocco
Omar El Khayyam middle school Agdal, Fez Fez 30000 Morocco
6 November middle school Sais, Fez Fez 30000 Morocco
Abdelmalek Essaadi middle school Jnan El Ouard, Fez Fez 30000 Morocco
Ain Bida middle school Ain Bida, Fez Fez 30000 Morocco
Oum Salam middle school Mariniyine, Fez Fez 30000 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
Sidi Mohammed Ben Abdellah University of Fez Imouzzer road B.P.2626 - 30000 Fez 30000 Morocco
Faculty of Medicine Pharmacy and Dentistry of Fez Box 1893 - KM 2.200 Sidi Harazem Road Fez, 30070 Fez 30070 Morocco
Hassan II University Hospital Centre Sidi Harazem Road, Fez Fez 30050 Morocco
National Initiative for Human Development Allal Ben Abdellah street Fez Fez 30050 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Moroccan Society for Nutritional and Behavioral Epidemiology KM 2.200 Sidi Harazem Road Fez, 30070 Fez 30070 Morocco Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hicham El Malki hicham.elmalki1@usmba.ac.ma +212613133010 Hay lamcalla, Fez
City Postal code Country Position/Affiliation
Fez 30000 Morocco PhD student
Role Name Email Phone Street address
Public Enquiries Btissame Zarrouq btissame.zarrouq@usmba.ac.ma +212614162638 B.P 5206 Bensouda, Fez
City Postal code Country Position/Affiliation
Fez 30000 Morocco habilitated professor in Biology and Epidemiology
Role Name Email Phone Street address
Scientific Enquiries Karima El Rhazi karima.elrhazi@usmba.ac.ma +212661480368 Sidi Harazem Road Fez, 30070
City Postal code Country Position/Affiliation
Fez 30070 Morocco Professor of Higher Education
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All de-identified participant data used and analysed in this study are available from the corresponding author on reasonable request (text, figures, tables and appendices). The study protocol, the statistical analysis, the consent form and the analytical report of the clinical study will also be shared. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 8 months and ending 36 months following article publication Researchers Who provide a mothodologically sound proposal / Investigators whose proposed use of the data has been approved by an independent review committee
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