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.: PACTR202004803366609 Date of Approval: 24/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Developing and assessing the acceptability and feasibility of a CBT-based psychoeducational intervention to support psychological well-being amongst adolescents in the Western Cape, South Africa.
Official scientific title Developing and assessing the acceptability and feasibility of a CBT-based psychoeducational intervention to support psychological well-being amongst adolescents in the Western Cape, South Africa.
Brief summary describing the background and objectives of the trial Globally, at least 1 in 5 children and adolescents experience mental health problems, and this number is likely to be even higher in low- and middle-income countries(LMIC), like South Africa (Kieling et al., 2011),where vulnerable populations face multiple adversities (Costello et al., 2003). In South Africa, the prevalence of anxiety disorders amongst children and adolescents is high, ranging from 22% to 25.6% amongst 7-13 years old (Perold, 2001). In South Africa, where access to mental health services is poor, the risk of developing mental health issues among children and adolescents is high. Accordingly, there is an urgent need to implement cost-, and time-effective interventions to address these issues in child-friendly, and child-accessible settings. Whilst nearly 90% of all children live in LMIC, only 10% of randomised trials are undertaken in these countries, with almost all being psychopharmacological trials (Kieling et al., 2011). This highlighted the need to develop and evaluate mental health prevention programmes for children in LMICs (Kieling et al., 2011) with schools providing a promising context for their delivery (Fazel et al., 2014). Evidence suggests that CBT-based interventions have potential to mitigate the onset of mental illness by addressing symptoms of anxiety and depression in younger children, and thus may be considered primary preventative interventions. We aim to determine the acceptability and feasibility of a culturally-specific and context-sensitive CBT-based psychoeducational programme to support psychological well-being amongst children and adolescents (11-14 years) in an impoverished area of the Western Cape.
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 Prevention
Anticipated trial start date 20/04/2020
Actual trial start date
Anticipated date of last follow up 01/10/2021
Actual Last follow-up date 01/10/2021
Anticipated target sample size (number of participants) 490
Actual target sample size (number of participants) 222
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised 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
Control Group Delayed intervention group The delayed intervention group (DIG) will receive the 'standard of care' which in this school setting means that they will receive Life Orientation as per the Department of Basic Education's curriculum. This entails 3 LO classes per grade per week. The DIG will then receive the same intervention as the IIG, after the 1 month follow up of the IIG. 8 weeks The delayed intervention group (DIG) will receive the 'standard of care' which in this school setting means that they will receive Life Orientation as per the Department of Basic Education's curriculum. This entails 3 LO classes per grade per week. The DIG will then receive the same intervention as the IIG, after the 1 month follow up of the IIG. 240 Dose Comparison
Experimental Group Immediate intervention group 1 session per week for 8 weeks with 1 session being between 20 -25 minutes. 8 weeks The manualised, non-therapeutic, life skills programme which we have created is called 4 steps to my future (4STMF) and contains four core steps. These four steps are based on the principles of CBT, and are designed to enhance self-esteem, promote helpful thinking, develop emotional regulation, and empower goal focused action. Each of the 4 core steps are designed to be delivered over two lessons lasting for 20-25 minutes per lesson. Thus, the programme is 8 lessons in total (approximately 3 - 4 hours in total). Each class lesson includes whole group, small group and individual tasks. Further details on the programme content and activities are available from the authors on request. Learners will be asked to complete tasks in between lessons to apply the skills learned in daily life. Classroom posters and some tangible materials will provide personal reminders of the skills learned at each step. An informational handout will be sent to parents/ caregivers after each step to inform them of the key learning points, what was done in the lessons, and how they can support this at home. 240
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• In grade 5 or grade 6 (aged 11- 13 years) at the participating schools • Provide written informed assent for participation • Have written parental permission for participation • Children at the participating schools not in grade 5 or grade 6 • Children who have not provided written informed assent for participation • Children without parental permission for participation Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 11 Year(s) 14 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 28/02/2020 Research Ethics Committee Social Behavioural and Educational Research Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
RW Wilcocks Building, Ryneveld Street, Stellenbosch University Stellenbosch 7600 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Acceptability and feasibility of intervention• Feasibility (Can we do it?) • Could we randomise schools to receive delivery? • Did any parents opt-out of the assessments? How many? (we hope for less than 20% parental opt-out). • Did any parents opt-out of the sessions? How many? • Can the programme fit into the existing curriculum? • Could the whole programme be delivered at each school? • Could all 8 sessions be completed at each school? • Did all of the children attend all 8 session? • Did all of the children complete all of the measures at each time point? (we hope for 80% completion of measures at each time point; (% missing data for each measure). Acceptability assessed through exit interviews with learners. immediately after intervention and at 1 month follow up
Secondary Outcome Anxiety and Depression measure: Revised Child Anxiety and Depression Scale - 30 (RCADS) (Chorpita et al., 2005). Happiness and well-being measure: Seven item, study specific visual analogue scale (scale from 1-7) on happiness and well-being. Emotion regulation measure: The Emotion Regulation Questionnaire for Children and Adolescents (ERQ–CA)(Gullone & Taffe, 2012). Bullying: 2-item The Olweus Bully/Victim Questionnaire-Modified (Strohmeier et al., 2011). Self-esteem measure: Rosenberg self-esteem scale (Rosenberg, 1965). Goal setting: Goal-Setting Scale (Webb & Baer, 1995). Stressful life events in the past 7 days: The revised child impact of events scale (CRIES) (at 1 month follow up only)(Perrin et al., 2005). This measure contains a screening question at the beginning to assess for eligibility for completing this measure. As such, not all children will necessarily be eligible to complete this measure in full. immediately after intervention and at 1 month follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Primary schools Cape Winelands District Cape Town 7600 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust Euston Road, London, NW1 London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bronwyne Coetzee RW Wilcocks Building, Ryneveld street Stellenbosch South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Paul Stallard Claverton Down, Bath BA2 7AY, United Kingdom London United Kingdom
Maria Loades Claverton Down, Bath BA2 7AY, United Kingdom London United Kingdom
Helene Loxton RW Wilcocks building, Ryneveld Street Stellenbosch 7600 South Africa
Gerrit Laning 21 Rustenberg Rd, Idasvallei, Stellenbosch, 7609 Stellenbosch 7600 South Africa
Naomi Myburgh RW Wilcocks building, Ryneveld Street Stellenbosch South Africa
Suzanne Human RW Wilcocks building, Ryneveld Street Stellenbosch South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bronwyne Coetzee bronwyne@sun.ac.za 00278083979 RW Wilcocks building, Ryneveld Street
City Postal code Country Position/Affiliation
Stellenbosch South Africa Lecturer Stellenbosch Univeristy
Role Name Email Phone Street address
Public Enquiries Suzanne Human shuman@sun.ac.za 00278083979 RW Wilcocks building, Ryneveld Street
City Postal code Country Position/Affiliation
Stellenbosch South Africa Project Manager Stellenbosch University
Role Name Email Phone Street address
Scientific Enquiries Bronwyne Coetzee bronwyne@sun.ac.za 00278083979 RW Wilcocks building, Ryneveld Street
City Postal code Country Position/Affiliation
Stellenbosch South Africa Lecturer Stellenbosch Univeristy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data collected for this pilot trial will be accessible in keeping with the Wellcome Trust data sharing policy: https://wellcome.ac.uk/grant-funding/guidance/data-software-materials-management-and-sharing-policy. Quantitative and qualitative data collected as part of this pilot intervention will be anonymized and made available to researchers on request from the principal investigator. Study Protocol The anonymised data collected in keeping with the aims and objectives of this pilot intervention will be made available following the last point of data collection i.e. at the one month follow up. In light of the COVID-19 disaster and the face that this intervention takes place in schools it is not possible to provide exact dates at this stage. We endeavor to update this as soon as possible. Quantitative and qualitative data collected as part of this pilot intervention will be anonymized and made available to researchers on request from the principal investigator.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 09/12/2022 COVID-19 09 Oct 2020 01 Oct 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 09/12/2022 COVID-19 01 Oct 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 09/12/2022 COVID-19 222
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 09/12/2022 Study is complete. Active, not recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 23/06/2021 This is the name of a participating school and we need to keep this anonymized.
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 23/06/2021 We need to keep the names of participating schools anonymized. Primary schools, Cape Winelands District, Cape Town, 7600, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 30/03/2020 Updated to include plan to share IPD. Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 30/03/2020 Updated to include IPD description. Data collected for this pilot trial will be accessible in keeping with the Wellcome Trust data sharing policy: https://wellcome.ac.uk/grant-funding/guidance/data-software-materials-management-and-sharing-policy. Quantitative and qualitative data collected as part of this pilot intervention will be anonymized and made available to researchers on request from the principal investigator.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 30/03/2020 Updated to include time frame. The anonymised data collected in keeping with the aims and objectives of this pilot intervention will be made available following the last point of data collection i.e. at the one month follow up. In light of the COVID-19 disaster and the face that this intervention takes place in schools it is not possible to provide exact dates at this stage. We endeavor to update this as soon as possible.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 30/03/2020 Updated to include access criteria. Quantitative and qualitative data collected as part of this pilot intervention will be anonymized and made available to researchers on request from the principal investigator.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 30/03/2020 Updated to include study protocol. Study Protocol