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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: www.pactr.org

Trial no.: PACTR201302000455414 Date registered: 2012/11/12
TRIAL DESCRIPTION
Public title Sinovuyo Caring Families Project
Official scientific title Preventing Abuse of Children in the Context of AIDS in Sub-Saharan Africa
Brief summary describing the background
and objectives of the trial
The overall goal of the Sinovuyo Caring Families Programme is to reduce the risk for child maltreatment and improve child behavior in high-risk South African and Southern African families. In order to attain this goal, it also has the following specific objectives: ¿ Increase parenting knowledge, skill and sense of competence ¿ Improve positive parenting behavior ¿ Improve parental supervision of children ¿ Decrease inconsistent and harsh discipline ¿ Improve caregiver mental health and social support ¿ Improve knowledge and use of social services for intimate partner violence and HIV ¿ Improve engagement in school and early childhood learning ¿ Improve adherence to medication and disclosure of illness
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Prevention
Anticipated trial start date 2012-12-07
Actual trial start date 2013-02-04
Anticipated date of last follow up 2013-06-14
Actual date of last follow up
Anticipated target sample size (number of participants) 60   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID
2012_12_01 University of Cape Town Department of Psychology Research Ethics Committee
SSD/CUREC2/11-40 University of Oxford 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
Single group: all participants receive same intervention throughout study Randomised Stratified allocation by child age, child gender, and recruitment group Block randomization by computer. Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Sinovuyo Caring Families Programme 12 sessions 2.5 hours each Group-based parenting programme 60 Active
Control group Wait-list control none none wait-list control 30 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Over age 18 Primary guardian of child age 3-8 Live in same household as child at least four nights per week Score above clinical cutoff of 10 on Eyberg Child Behaviour Inventory problem scale Only one guardian per household may participate 18 Years 90 Years 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 2012/12/01 Department of Psychology Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
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 2011/11/09 SOCIAL SCIENCES & HUMANITIES INTER-DIVISIONAL RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Hayes House, 75 George Street Oxford OX1 2BQ United Kingdom

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Eyberg Child Behavior Checklist (Eyberg and Ross, 1978) (child behavior problems) Pre-test (February 2013), Post-test (June 2013)
Primary Outcome Observations based on a short form of the Dyadic Parent-Child Interaction System. Pre-test (February 2013), Post-test (June 2013), one year follow-up (June 2014).
Primary Outcome Parent-Child Conflict Tactics Scale (Straus et al., 1998) (Harsh and Inconsistent parenting) Pre-test (February 2013), Post-test (June 2013)
Primary Outcome Parenting Young Children Scale (McEachern et al., 2011) (Positive parenting) Pre-test (February 2013), Post-test (June 2013)
Secondary Outcome Parenting Stress Index ¿ Short Form (Abidin, 1995) (Parenting distress) Pre-test (February 2013), Post-test (June 2013)
Secondary Outcome Beck Depression Index-II (Beck and Steer 1996) (Parental depression) Pre-test (February 2013), Post-test (June 2013)
Secondary Outcome Multidimensional scale of perceived social support ((Dahlem, 1991) (perceived social support) Pre-test (February 2013), Post-test (June 2013)

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ikamva Labantu Wellness Centre Lubelwana Street Cape Town 7784 South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
National Lottery Distribution Fund Block B Hatfield Gardens Hatfield, Pretoria 0082 South Africa
Ilifa Labantwas 6 Wodin Road Claremont 7788 South Africa
John Fell Fund 32 Wellington Square Oxfords OX1 2ER United Kingdom

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ilifa Labantwana Fund 1 Wodin Road, Claremont Cape Town 7784 South Africa Funding Agency

COLLABORATORS
Name Street address City Postal code Country
Frances Gardner Department of Social Policy and Intervention, University of Oxford Oxford United Kingdom
Judy Hutchings Centre for Evidence-Based Early Intervention, Bangor University Bangor United Kingdom
Clowns Without Borders South Africa 45 Maritime Rd Durban 4001 South Africa
The Parent Centre 123 Main Road Wynberg, Cape Town 7800 South Africa

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Lucie Cluver lucie.cluver@spi.ox.ac.uk +44 1865 270325 +44 1865 270325
Street address City Postal code Country Position / Affiliation
32 Wellington Square Oxford OX1 2ER United Kingdom University of Oxford
Role Name Email Phone Fax
Principal Investigator Dr Catherine Ward Catherine.Ward@uct.ac.za +27-21-650-3422 +27-21-650-4104
Street address City Postal code Country Position / Affiliation
Room 2.09, Department of Psychology PD Hahn Building University of Cape Town Cape Town 7946 South Africa University of Cape Town
Role Name Email Phone Fax
Public Enquiries Mr Jamie Lachman jamie.lachman@gmail.com 447717548771
Street address City Postal code Country Position / Affiliation
32 Wellington Square Oxford OX1 2ER United Kingdom Researc
Role Name Email Phone Fax
Scientific Enquiries Dr Lucie Cluver lucie.cluver@spi.ox.ac.uk +44 1865 270325 +44 1865 270325
Street address City Postal code Country Position / Affiliation
32 Wellington Square Oxford OX1 2ER United Kingdom University Lecturer