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.: PACTR201302000455414 Date of Approval: 12/11/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
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 families in South Africa. 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 Child Behavior Problems, Child Maltreatment, Parental Mental Health,Infections and Infestations,Mental and Behavioural Disorders,Paediatrics
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 07/12/2012
Actual trial start date 04/02/2013
Anticipated date of last follow up 14/06/2013
Actual Last follow-up date 14/06/2013
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 68
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
Randomised Stratified allocation by child age, child gender, and recruitment group Block randomization by computer. Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Wait-list control none none wait-list control 30 Active-Treatment of Control Group
Experimental Group Sinovuyo Caring Families Programme 12 sessions 2.5 hours each Group-based parenting programme 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum 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 Year(s) 90 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 01/12/2012 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 09/11/2011 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
John Fell Fund 32 Wellington Square Oxfords OX1 2ER United Kingdom
National Lottery Distribution Fund Block B Hatfield Gardens Hatfield, Pretoria 0082 South Africa
Ilifa Labantwana 6 Wodin Road Claremont 7788 South Africa
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
Clowns Without Borders South Africa 45 Maritime Rd Durban 4001 South Africa
The Parent Centre 123 Main Road Wynberg, Cape Town 7800 South Africa
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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lucie Cluver lucie.cluver@spi.ox.ac.uk +44 1865 270325 32 Wellington Square
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom University of Oxford
Role Name Email Phone Street address
Principal Investigator Catherine Ward Catherine.Ward@uct.ac.za +27-21-650-3422 Room 2.09, Department of Psychology PD Hahn Building University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7946 South Africa University of Cape Town
Role Name Email Phone Street address
Public Enquiries Jamie Lachman jamie.lachman@gmail.com 447717548771 32 Wellington Square
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom Researc
Role Name Email Phone Street address
Scientific Enquiries Lucie Cluver lucie.cluver@spi.ox.ac.uk +44 1865 270325 32 Wellington Square
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom University Lecturer
REPORTING
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