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.: PACTR201507001119966 Date of Approval: 27/04/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sinovuyo Caring Families- Teen, for 10-17 year olds
Official scientific title Preventing abuse of children in the context of AIDS in sub-Saharan Africa (PACCASA)
Brief summary describing the background and objectives of the trial Child abuse, harsh parenting and adolescent behaviour problems are of major concern internationally, but low and middle income countries have even fewer services to address and prevent them. With the World Health Organisation, UNICEF and USAID-PEPFAR colleagues, a team of academics have developed parenting support programmes based on the high-quality evidence established in HIC (Barlow et al 2006). These programmes ¿Parenting for Lifelong Health¿ are all designed to be implemented at very low cost, by non-professional community workers. These are being initially developed and tested in South Africa. The Sinovuyo Teen programme is aimed at families of 10-17 year olds, in contexts of high violence, HIV/AIDS and poverty, and has been developed with community and NGO input. The programme has undergone two pre-post tests in the development stages (participant n= 290), and is now being tested in an RCT. It is a 14-week programme with primary caregivers (henceforth called ¿parents¿) and adolescents. Primary outcomes include 1) parenting and 2) harsh and abusive discipline, and secondary outcomes of 3) externalizing behaviour; 4) parenting stress; 5) mental health; 6) social support; and exploratory outcomes of 7) family finance coping; 8) educational outcomes, and 9) avoiding risk in the community. The trial was originally planned as individually-randomised, but in the pilot tests there was extensive dissemination of the programme by participants, churches and schools. Hence, a cluster RCT is necessary. However, budget and NGO capacity limit the number of communities and so we intend to follow other violence RCTs such as SASA that share similar limitations (Abramsky et al, Trials, 2012) When interpreting results, emphasis will be on assessing whether change has occurred in the hypothesised direction and if so the magnitude of the observed effect. In particular, whether changes observed across all outcomes are in the expected direction and largely coherent with one another.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PACCASA
Disease(s) or condition(s) being studied Child maltreatment, harsh parenting, exposure to community violence,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 02/05/2015
Actual trial start date 02/05/2015
Anticipated date of last follow up 01/05/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 1200
Actual target sample size (number of participants) 1200
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
21.05.2014 Department of Social Development & Special Programmes, Province of the Eastern Cape
2012_05_01 Department of Psychology Research Ethics Committee (UCT)
2014/04/04 Strategic Planning Policy Research and Secretariat Services, Department of Education, Eastern Cape
313421-PACASSA European Research Council
SSD/CUREC2/11-40 Social Sciences & Humanities Inter-Divisional Research Ethics Committee
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 (villages vs townships) Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Hope Soap Once Half day Hygiene intervention for families of the teens and caregivers within the control group. We aim to provide each family with hope soaps (soaps with toys inside) and ordinary soap bars. Furthermore, teenagers will be encouraged to help in the construction of the tippy tap ¿ an activity to help wash in clean water. The intervention demonstration will be conducted by 3-4 facilitators 600 Active-Treatment of Control Group
Experimental Group Sinovuyo Teen Parenting Porgramme 3 hours 14 weeks Group sessions in local community spaces (separate sessions for parents and adolescents and joint parent-adolescent sessions). Participants also receive weekly tasks to complete at home (home practice)The program manuals have been developed by the Universities of Oxford and Cape Town and Clowns Without Borders South Africa, with advice and support from over 50 experts in the field. 600 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for children include: Age 10-17 at initial assessment Lives in the dwelling at least 4 nights per week Must have an adult primary caregiver who lives in the household, who provides consent, and who participates in the study Provides assent to participate in the full study including intervention and completing baseline, immediate post-test, and 12-month follow-up assessments. Being able to attend the sessions in the afternoon on workdays Referred by social services, schools, local traditional leaders or self-referred for experiencing conflict in their family. Inclusion criteria for adults include: Age 18 or older Serves as the primary caregiver of the child participant Lives in the dwelling at least 4 nights per week. Provides consent to participate in the full study including intervention and completing baseline, immediate post-test, and 12-month follow-up assessments Being able to attend the sessions in the afternoon on workdays Referred by social services, schools, local traditional leaders or self-referred for experiencing conflict in their family. Children with severe learning disabilities who are not able to assent. Adults with learning disabilities who are not able to consent. 10 Year(s) 100 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 09/11/2011 Social Sciences & Humanities Inter-Divisional Research Ethics Committee, University of Oxford
Ethics Committee Address
Street address City Postal code Country
Hayes House, 75 George Street Oxford OX1 2BQ United Kingdom
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 04/12/2012 Psychology Department Research Ethics Committee, University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Department of Psychology University of Cape Town Rondebosch, Cape Town 7701 South Africa
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 04/04/2014 Strategic Planning Policy Research and Secretariat Services, Department of Education Eastern Cape
Ethics Committee Address
Street address City Postal code Country
Steve Vuklle Tshwete Complex Zone 6 Bhisho 5605 South Africa
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 21/05/2014 Provincial Department of Social Development and Special Programmes, Eastern Cape
Ethics Committee Address
Street address City Postal code Country
172 Ideal Homes Building Oxford Street Bisho 5605 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Harsh and abusive discipline T0: Baseline T1: Post-test T2: 1 year follow-up
Primary Outcome Parenting T0: Baseline T1: Post-test T2: 1 year follow-up
Secondary Outcome Externalizing behavior T0: Baseline T1: Post-test T2: 1 year follow-up
Secondary Outcome Parenting stress T0: Baseline T1: Post-test T2: 1 year follow-up
Secondary Outcome Mental Health T0: Baseline T1: Post-test T2: 1 year follow-up
Secondary Outcome Social support T0: Baseline T1: Post-test T2: 1 year follow-up
Secondary Outcome Family financial coping (exploratory) T0: Baseline T1: Post-test T2: 1 year follow-up
Secondary Outcome Avoiding risk in the community (exploratory) T0: Baseline T1: Post-test T2: 1 year follow-up
Secondary Outcome Education (exploratory) T0: Baseline T1: Post-test T2: 1 year follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
King William¿s Town and 40 surrounding villages King William's Town South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
European Research Council Covent Garden Place Charles Rogier 16 Saint-Josse-ten-Noode (Brussels) 1210 Belgium
Leverhulme trust 1 Pemberton Row London EC4A 3BG United Kingdom
Economic and Social Research Council Polaris House North Star Avenue Swindon SN2 1UJ United Kingdom
John Fell Fund Oxford University Fund Great Clarendon Street Oxford OX2 6DP United Kingdom
Cambridge Trust The Old Schools, Trinity Lane, Cambridge CB2 1TN United Kingdom
UNICEF South Africa 351 Francis Baard Street 6th Floor, Metro Park Building Pretoria 0001 South Africa
UNICEF Innocenti Research Centre Piazza SS. Annunziata, 12 Florence 50122 Italy
National Department of Social Development Thusanong Building, 11th Floor, 69 Commissioner Street Johannesburg 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Clowns Without Borders 45 Maritime Place Durban 4000 South Africa Charities/Societies/Foundation
Secondary Sponsor UNICEF Headquaters House 3 United Nations Plaza New York, New York 10017 United States of America Funding Agency
Secondary Sponsor Department of Social Development Thusanong Building, 11th Floor, 69 Commissioner Street Johannesburg 0001 South Africa Funding Agency
Secondary Sponsor Strategic Planning Policy Research and Secretariat Services, Department of Education Eastern Cape Steve Vuklle Tshwete Complex Zone 6 Bhisho 5605 South Africa Funding Agency
Secondary Sponsor Provincial Department of Social Development and Social Programmes, Eastern Cape 172 Ideal Homes Building, Oxford Street East London 5605 South Africa Funding Agency
Secondary Sponsor National Department of Basic Education Sol Plaatje House 222 Struben Street Pretoria 0001 South Africa Funding Agency
Secondary Sponsor UNICEF Innocenti Research Centre Piazza SS. Annunziata, 12 Florence 50122 Italy Funding Agency
Secondary Sponsor UNICEF South Africa 351 Francis Baard Street 6th Floor, Metro Park Building Pretoria 0001 South Africa Funding Agency
Secondary Sponsor World Health Organization Avenue Appia 20 Geneva 1211 Switzerland Funding Agency
Secondary Sponsor University College London Gower Street London WC1E 6BT United Kingdom University
Secondary Sponsor Institute of Criminology, University of Cambridge Sidgwick Avenue Cambridge CB3 9DA United Kingdom University
Primary Sponsor Department of Social Policy and Intervention, University of Oxford Barnett House 32 Wellington Square Oxford OX1 2ER United Kingdom University
Primary Sponsor Department of Psychology, University of Cape Town Rondebosch 7701 Rondebosch 7701 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Medical Research Council Francie van Zijl Drive Cape Town 7501 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lucie Cluver lucie.cluver@spi.ox.ac.uk +44 1865 270 325 32 Wellington Sq, Barnett Hse, Dept Social Policy and Intervetnion Oxford Univ
City Postal code Country Position/Affiliation
Oxford OX2 2ER United Kingdom Assoc Prof Dept Social Policy & Intervention, Oxford Univ; Dept Psychiat & Mental Health, UCT
Role Name Email Phone Street address
Public Enquiries Sarah Hoeksema sarah.hoeksema@spi.ox.ac.uk +44 1865 270 325 32 Wellington Sq, Barnett Hse, Dept Social Policy and Intervetnion Oxford
City Postal code Country Position/Affiliation
Oxford OX2 2ER United Kingdom Administrative Assistant
Role Name Email Phone Street address
Scientific Enquiries Lucie Cluver lucie.cluver@spi.ox.ac.uk +44 1865 270 325 32 Wellington Sq, Barnett Hse, Dept Social Policy and Intervention Oxford Univ
City Postal code Country Position/Affiliation
Oxford OX2 2ER United Kingdom Assoc Prof Dept Social Policy & Intervention, Oxford Univ; Dept Psychiat & Mental Health, UCT
REPORTING
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