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.: PACTR202210858972421 Date of Approval: 18/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF CHILD MENTAL HEALTH LITERACY PROGRAM ON TEACHERS’ KNOWLEDGE, ATTITUDE AND PERCEIVED SELF EFFICACY TOWARDS MENTAL HEALTH PROBLEMS IN SELECTED PRIMARY SCHOOLS, ENUGU METROPOLIS
Official scientific title EFFECT OF CHILD MENTAL HEALTH LITERACY PROGRAM ON TEACHERS’ KNOWLEDGE, ATTITUDE AND PERCEIVED SELF EFFICACY TOWARDS MENTAL HEALTH PROBLEMS IN SELECTED PRIMARY SCHOOLS, ENUGU METROPOLIS
Brief summary describing the background and objectives of the trial Mental health problems during childhood account for substantial health and societal burden (Scott et al., 2016). Existing evidence has shown that untreated child mental health conditions severely influence a child’s development, educational achievements, and potential to live fulfilling and productive lives (Schulte-Korne, 2016; WHO, 2018). Considering the high burden of these common conditions, promoting positive mental health and wellbeing throughout a child’s developmental milestone has been integrated into the United Nations’ sustainable developmental goals (Vortuba & Thornicroft, 2016). Teachers are valuable stakeholders with considerable impact on pupils due to their daily contact which avail them the opportunity to visualize their development (House of Commons, 2017). They are often the first professionals to identify and respond to children’s mental health challenges/needs. Hence, are key personnel for the implementation of classroom mental health programs and providing a conducive learning environment suitable for the growth of a child (Chorcora & Swords, 2021; Reinke et al., 2011). Mental health literacy is a significant determinant of mental health in the general population (Bröder et al., 2017; Kutcher et al., 2016). evidence shows that many non-professionals including teachers are not well informed about how to recognize and respond to mental health problems; what services and effective treatments are available. Poor knowledge of mental health symptoms in children is greatly associated with the inability to identify children with related problems, negative attitudes and restricted support towards children experiencing mental health difficulties. Therefore, promoting teachers’ knowledge of mental health disorders in children, demystifying erroneous beliefs and boosting their confidence in helping pupils with such difficulties through a variety of literacy programmes is paramount. The objectives of the study are to: 1. Assess the pre-intervention and post intervention level knowledge of child mental health problems among teachers in selected primary schools in Enugu Metropolis, Nigeria. 2. Determine the pre-intervention and post-intervention level of knowledge of behavioural manifestations of child mental health problems among teachers in selected primary schools in Enugu Metropolis, Nigeria 3. Ascertain the pre-intervention and post-intervention level of knowledge of classroom management strategies for childhood mental health problems among teachers in selected primary schools. 4. Determine the pre-intervention and post-intervention attitude of teachers towards child mental health problems in selected primary schools in Enugu Metropolis, Nigeria. 5. Determine the pre-intervention and post-intervention perceived self-efficacy of teachers towards child mental health problems in selected primary schools in Enugu Metropolis, Nigeria.
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 25/11/2022
Actual trial start date
Anticipated date of last follow up 10/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 280
Actual target sample size (number of participants)
Recruitment status Active, not 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Child mental health literacy Four times ( weekly) Four weeks The intervention package in this study is child mental health literacy course designed to provide primary school teachers with a better understanding of child’s mental health, some selected mental health disorders in childhood and how to effectively manage children with mental health problems in the classroom. The training programme will demystify some negative belief about child mental illness by providing them evidence based information and facts about child mental problems, consequently restructuring their negative notions and attitude about this vulnerable group. Generally, the training programme will empower the teachers to identify these children at the early stage, assist them to develop strategies to manage them and minimize any potential sequale in adulthood which limits oppourtunities of leading fulfilling life. 160
Control Group Stress management Once One week For the control group, one-day seminar on stress management will be provided to the teachers which will run concurrently with the CMH training programmes delivered to the intervention group. The topics will range on definition of stress, causes of stress, types of stress, signs and symptoms of stress and how to cope with stress. After obtaining the post-intervention data, respondents in the control group will be provided the same CMH training given to the intervention group in order to compensate them. 120 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Schools that offers general education program from preschool to primary school 2. Comparable schools in terms of geographical distribution, educational philosophy 3. Schools with teachers’ population of at least 12. 4. Teacher have at least six (6) months year of teaching experience 5. Teacher must be 18 years or older. 6. The teacher must be willing to participate and available at the time of the study Schools or teachers who had undergone any child mental health training within the previous three years. 2. Schools owned by mission or churches will not participate in the study restrict the scope. 3. Schools that use subject teaching models rather than classroom method will not be included. 4. Teachers who have not been involved in active teaching in last 6 months. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 12/06/2022 Health research and ethical committee University of Nigeria teaching hospital Ituku Ozalla
Ethics Committee Address
Street address City Postal code Country
University of Nigerian Teaching Hospital Ituku-Ozalla Enugu Port- Harcourt Express Way Enugu. Enugu 400001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome measure is to determine whether teachers who received the child mental health training programme had better knowledge, favourable attitude and improved self-efficacy towards mental health problems in childhood. Baseline, immediately following intervention and 8 weeks after intervention
Secondary Outcome The secondary outcomes are if the training programme led to more: 1. Knowledge about causes, manifestations and classroom management of child mental health problems 2. Positive attitude towards children with mental health disorders. 3. Confidence in their ability to recognise and effectively manage children with mental health problems in the classroom 4. Ability to identify and manage children with mental health problems in the classroom Baseline, after intervention, 8weeks after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Primary schools in Enugu metropolis Enugu north Enugu Nigeria
Primary schools in Enugu metropolis Enugu East Enugu Nigeria
Primary Schools in Enugu metropolis Enugu South Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Mbadugha Chisom Joy Department of Nursing Sciences, University of Nigeria Enugu Campus Enugu 400006 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mbadugha Chisom Joy.. self No 3 Ben Eneh Lane New Haven Enugu Enugu Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chisom Joy Mbadugha chisom.mbadugha@unn.edu.ng +23407030821648 No 3 Ben Eneh Lane New Haven Enugu
City Postal code Country Position/Affiliation
Enugu Nigeria Lecturer University of Nigeria
Role Name Email Phone Street address
Public Enquiries Pleasure Nwakaego Ogbonna pleasure.ogbonna@unn.edu.ng +23437410398 Department of Nursing sciences University of Nigeria Enugu campus
City Postal code Country Position/Affiliation
Enugu 400006 Nigeria Lecturer 1 university of Nigeria
Role Name Email Phone Street address
Scientific Enquiries Chisom Joy Mbadugha chisom.mbadugha@unn.edu.ng +23407030821648 Department of nursing sciences University of Nigeria Enugu Campus
City Postal code Country Position/Affiliation
Enugu 400006 Nigeria Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose
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