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.: PACTR202111481603475 Date of Approval: 30/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF AN ASSERTIVENESS TRAINING PROGRAMME ON SELF-ESTEEM AND ASSERTIVENESS SKILLS OF VICTIMS OF BULLYING IN A SECONDARY SCHOOL IN IBADAN, NIGERIA.
Official scientific title EFFECT OF AN ASSERTIVENESS TRAINING PROGRAMME ON SELF-ESTEEM AND ASSERTIVENESS SKILLS OF VICTIMS OF BULLYING IN A SECONDARY SCHOOL IN IBADAN, NIGERIA.
Brief summary describing the background and objectives of the trial This study aims to assess the effect of an assertiveness training program on the self-esteem and assertiveness skills of victims of bullying in a secondary school in Ibadan. Bullying is a global problem observed in any school and research has shown the negative effect of bullying on victims and bullies alike. Victims of bullying develop psycho-social problems like anxiety, depression, low self-esteem etc. as compared to non-victims. Assertiveness training program is a structured behavioral intervention design to improve assertive behavior and interpersonal relations of people of different ages and background. Due to the reduced resources and socio- cultural differences in a developing country like Nigeria, it is not certain if some standard strategies on assertiveness training would be feasible. Hence the need to explore the concept of how assertiveness training produce efficacy on victims of bullying in a low income settings.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PVS RAS RSES
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 13/10/2021
Actual trial start date 13/10/2021
Anticipated date of last follow up 10/11/2021
Actual Last follow-up date 10/11/2021
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Assertive Training Program 5 weeks The Assertive Training program is a structured behavioral therapy which include psycho-education, group role playing and homework. The assertiveness training program will consist of 5 sessions that will be offered weekly lasting for 45minutes. Participant will learn how to distinguish assertive behavior from aggressive or passive behavior, learn the behavioral components of assertion and then practice them, learn how to say yes or no, showing positive affection, negative affection and effective criticism etc. at the end of each session, there will be a recap of what had been learnt and assignment will be given to enable participant practice the skills they had learnt. 25
Control Group Assertive Training Program 5 weeks The control group did not receive any intervention 25 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The participants must be Junior secondary school students They must be between age 10 and 17 years The parent must give informed consent Student having severe mental illness were excluded from the study Adolescent: 13 Year-18 Year 10 Year(s) 17 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 15/11/2021 Oyo State Reseach Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, Oyo state secretariat, Agodi Ibadan ibadan 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome There will be a significant difference in the self esteem of the experimental group who receive assertiveness training and the control group who do not. 1 week after the final session of the assertiveness training program
Secondary Outcome there will be a significant difference in the assertiveness skills of the experimental group who receive assertive training and the control who do not. 1 week after the final session of the assertiveness training program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Immanuel College UI Ibadan Orita, University of Ibadan Ibadan 23401 Nigeria
Fazlomar Ahmadiyyah College Ajibola Aremo Ibadan 23401 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Oloruntoba Ridwan Ayodeji Centre for Child and Adolescent Mental Health University of Ibadan ibadan 23401 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oloruntoba Ridwan Ayodeji Centre for Child and Adolescent Mental Health, University of Ibadan Ibadan 23401 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ridwan Oloruntoba oloruntobaridwan@gmail.com +2347037297349 Centre for Child and Adolescent Mental Health, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 23401 Nigeria Graduate Student
Role Name Email Phone Street address
Scientific Enquiries Haleem Abdurrahman haleemabiodun@yahoo.co.uk 08024934976 Centre for Child and Adolescent Mental Health, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 23401 Nigeria Senior lecturer
Role Name Email Phone Street address
Scientific Enquiries Titilope Bella Awusah bellatt2002@yahoo.com 08025905241 Centre for Child and Adolescent Mental Health, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 23401 Nigeria Senior lecturer
Role Name Email Phone Street address
Public Enquiries Kunle Omojola ccamhibadan@ymail.com +2348109854936 Center for Child and Adolescent Mental Health, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Program Officer Center for Child and Adolescent Mental Health
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) Analytic Code,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal
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