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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201808181810124 Date of Registration: 21/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Friendship Bench for adolescents
Official scientific title The Friendship Bench for adolescents: evaluating strategies for scaling interventions to treat common mental disorders among adolescents in Zimbabwe
Brief summary describing the background and objectives of the trial Friendship Bench is a 6-session problem solving therapy programmed delivered by a trained lay health worker at primary care clinics. In a previous trial we found that Friendship Bench significantly improved symptoms of common mental disorders (CMD) and depression score at 6 months, for participants aged 18 and above. In this trial we plan to implement an enhanced Friendship Bench package for young people (YouFB). The objectives are to determine the uptake, acceptability, adherence, effectiveness and cost-effectiveness of two strategies to deliver the Friendship Bench intervention to 16-19 year olds with CMD - (i) the standard care clinic-based delivery currently being scaled-up for adults (n=15 clinics) and (ii) the enhanced YouFB package (n=15 clinics) over a 6-month period. Outcomes will be measured in a nested cohort (375 participants in the intervention arm, 125 in the control arm).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) YouFB
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/09/2018
Actual trial start date
Anticipated date of last follow up 01/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants)
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 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard care FB 6 sessions 12 weeks Adolescents with CMD symptoms will be enrolled at clinics only. Trained lay health workers will deliver standard-care FB:a problem-solving therapy (PST) package delivered over 4-6 weeks, followed by a 6-week group support programme which focuses mainly on teaching a craft skill. 125 Active-Treatment of Control Group
Experimental Group Youth friendly FB 6 sessions 12 weeks Adolescents with common mental disorder symptoms will be enrolled at clinics and in the community. Youth counsellors will act as advocates for mental health and mobilise young people through schools, youth groups and social media. They will also delvier an adapted youth-friendly version of standard FB: a problem-solving therapy (PST) package delivered over a 4–6-week period followed by a 6-week group support programme. 375
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescents aged between 16-19 years old who live within the clinic catchment area, are able to give written informed consent, and score above a cut-off point of 8 in the SSQ-14 will be eligible Inability to comprehend the nature of the study in either English or Shona Individuals needing acute care or immediate referral to a tertiary facility (medical condition, psychotic or actively suicidal). All those excluded for medical reasons will be referred for appropriate care to a tertiary facility Adolescent: 13 Year(s)-17 Year(s) 16 Year(s) 19 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 24/07/2018 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
Josiah Tongogara / Mazoe Street Harare 9990 Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Common mental disorder symptoms assessed using the SSQ-14 6 months after enrolment
Primary Outcome Depression score measured using the PHQ-9 6 months after enrolment
Secondary Outcome Anxiety score measured using the GAD-7 6 months after enrolment
Secondary Outcome Disability in daily living assessed using the WHO-DAS 6 months after enrolment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Avondale Clinic Block D. Derry Circle Avondale Harare Zimbabwe
Glen View Satellite Clinic 12 Crescent Glen View Harare Zimbabwe
Arcadia Clinic Woodstock Avenue Arcadia Harare Zimbabwe
Mabelreign Clinic 425 Sherwood Drive Mabelreign Harare Zimbabwe
Marlborough Clinic Elizabeth Windsor Drive Marlborough Harare Zimbabwe
Waterfalls Clinic 107 Powell Road Waterfalls Harare Zimbabwe
Glen View Polyclinic 9446 Patrenda Way Glen View Harare Zimbabwe
Highfields Clinic 3363 Jabavu Drive Highfield Harare Zimbabwe
Kuwadzana Clinic 8216 56 Crescent Kuwadzana Harare Zimbabwe
Rutsanana Clinic 7505 Tawaziwa Way Glen Norah Harare Zimbabwe
Budiriro Polyclinic 684 5th Road Budiriro Harare Zimbabwe
Kambuzuma Polyclinic 2469 Kambuzuma Drive Kambuzuma Harare Zimbabwe
Mabvuku Polyclinic Manresa Way Mabvuku Harare Zimbabwe
Mt Pleasant Clinic Erskine Road Mt. Pleasant Harare Zimbabwe
Borrowdale Clinic Gaydon Road, Borrowdale Harare Zimbabwe
Hatfield Clinic St Patricks Road Hatfield Harare Zimbabwe
Belvedere Clinic 5326 Princess Road Belvedere Harare Zimbabwe
Sunningdale Clinic 16632 2nd Road Sunningdale Harare Zimbabwe
Dzivaresekwa Clinic 1507 Rujeko Street Dzivarasekwa Harare Zimbabwe
Warren Park Clinic 3rd Avenue, Warren Park Harare Zimbabwe
Glen Norah Clinic 8569 Zvimba Street Glen Norah Harare Zimbabwe
Mabvuku Satellite Clinic Marembo Street Mabvuku Harare Zimbabwe
Mufakose Clinic Mumhonda Road Mabvuku Harare Zimbabwe
Western Triangle Clinic Off Mangwende Drive Highfield Harare Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Liverpool School of Tropical Medicine Pembroke Pl Liverpool United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Liverpool School of Tropical Medicine Pembroke, PI Liverpool United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Dr. Webster Mavhu 9 Monmouth Rd Avondale West Harare Zimbabwe
Prof. Frances Cowan 9 Monmouth Rd Avondale West Harare Zimbabwe
Prof. Helen Weiss LSHTM, Keppel Street London United Kingdom
Prof. Ricardo Araya Institute of Psychiatry, de Crespigny Park London United Kingdom
Dr. Melanie Abas Institute of Psychiatry, De Crespigny Park London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dixon Chibanda dichi@zol.co.zw +263712204107 University of Zimbabwe College of Health Sciences, Research Support Centre, Parirenyatwa Hospital, Mazoe street
City Postal code Country Position/Affiliation
Harare Zimbabwe Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Dixon Chibanda dichi@zol.co.zw +263712204107 University of Zimbabwe College of Health Sciences, Research Support Centre, Parirenyatwa Hospital, Mazoe street
City Postal code Country Position/Affiliation
Harare Zimbabwe Principal Investigator
Role Name Email Phone Street address
Public Enquiries Biggy Dziro biggydziro@gmail.com +263773816634 University of Zimbabwe, Department of Psychiatry, College of Health Sciences, Mazowe Street, Avondale
City Postal code Country Position/Affiliation
Harare Zimbabwe Public Enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A fully anonymised version of the data will be made publicly accessible via a curated data repository Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year after end of study Data will be stored in a curated repository. Third parties may apply for access through the repository. Requests will be considered by a panel including the CI with a response within 30 days.
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