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.: PACTR201402000755243 Date of Approval: 30/01/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sinovuyo Caring Families Project
Official scientific title Sinovuyo Caring Families Project
Brief summary describing the background and objectives of the trial It has been established that children in families affected by either intimate partner violence or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) are at substantially increased risk of poor parenting and child maltreatment. In the sub-Saharan African context of high levels of HIV/AIDS and family violence, it is crucial that parents be supported to establish positive parenting practices and reduce harsh or abusive parenting within their families.This randomized controlled trial will be testing the Sinovuyo Caring Families Program (n = 240), a 12-session (2.5 hour per session) parenting intervention for primary caregivers of children between 2 and 9 years old. Participants will not be restricted to biological parents and include primary caregivers of children between 2 and 9 years old, who live in the same house as the child at least 4 nights per week. Participants will be recruited through systematic household sampling, liaising with Western Cape Department of Social Development and local community-based NGOs. Self-reporting questionnaires and qualitative observational assessment data for intervention and control groups will be collected at pre- and post-test evaluation as well as 12-month follow-up. Primary outcomes will include child behaviour problems, harsh and inconsistent parenting and positive parenting. Secondary outcomes will include parental depression, parental stress, parental monitoring and supervision and parent perceived social support.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Child behaviour problems
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 17/02/2014
Actual trial start date 19/02/2014
Anticipated date of last follow up 16/11/2015
Actual Last follow-up date 03/03/2016
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 296
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation by child age, child gender and recruitment group 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
Experimental Group Sinovuyo parenting programme One 3-hour sessions per week 12 to 14 weeks Sinovuyo parenting programme 120 Active-Treatment of Control Group
Control Group None None None No intervention 120 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Caregiver must live with child at least 4 nights per week Child must be between 2 and 9 years old Live in Khayelitsha or Nyanga Mayy include biological parents, relatives or non-kin foster caregivers, with no restrictions on biological relationship Participant must self-identify as the primary caretaker of the child Children scoring 15 or higher in the Eyberg Child Behaviour Inventory problem scale will be included. Children scoring 14 or lower in the Eyber Child Behaviour Inventory problem scale will be excluded. Participants with child not between 2 and 9 years old. Participants not self-identifying as the primary care take of the child. Participants not living with the child at least 4 nights per week. 18 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 Social Sciences and Humanities Inter-divisional Research Ethics Committee (IDREC)
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 24/02/2014 Ethics Review Committee of the Faculty of Humanities
Ethics Committee Address
Street address City Postal code Country
Department of Psychology, University Avenue 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 21/05/2014 Social Sciences and Humanities Inter-divisional Research Ethics Committee (IDREC)
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 Child behaviour problems Baseline observational assessment Post programme observational assessment 12-month follow-up observational assessment
Primary Outcome Positive parenting Baseline self-report assessment Post programme self-report assessment 12-month follow-up self-report
Primary Outcome Harsh and inconsistant parenting Baseline self-report assessment Post programme self-report assessment 12-month follow-up self-report
Secondary Outcome Parental depression Baseline self-report assessment Post programme self-report assessment 12-month follow-up self-report
Secondary Outcome Parental stress Baseline self-report assessment Post programme self-report assessment 12-month follow-up self-report
Secondary Outcome Parental monitoring and supervision Baseline self-report assessment Post programme self-report assessment 12-month follow-up self-report
Secondary Outcome Positive Parenting Baseline self-report assessment Post programme self-report assessment 12-month follow-up self-report
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Western Cape Department of Social Development Union House, 14 Queen Victoria Street Cape Town 8001 South Africa
Child Welfare Lower Klipfontein Road Cape Town 7766 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Ilifa Labantwana Douglas Murray House, 1 Wodin Road Cape Town 7735 South Africa
Rand Merchant Bank - Tshikululu Social Investments 8 Hillside Road Johannesburg 2107 South Africa
ApexHi Charitable Trust - Tshikululu Social Investments 8 Hillside Road Johannesburg 2107 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ilifa Labantwana Douglas Murray House, 1 Wodin Road Cape Town 7735 South Africa Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Clowns Without Borders South Africa 45 Maritime Rd Durban 4001 South Africa
Ilifa Labantwana 1 Lubelwana Street Cape 7784 South Africa
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 Research
Role Name Email Phone Street address
Public Enquiries Inge Wessels inge.m.wessels@gmail.com +27 (83) 5541791 Department of Psychology PD Hahn Building University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7946 South Africa Research
Role Name Email Phone Street address
Scientific Enquiries Jamie Lachman jamie.lachman@gmail.com +447717548771 32 Wellington Square
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom Researcher
Role Name Email Phone Street address
Scientific Enquiries Inge Wessels inge.m.wessels@gmail.com +27 (83) 5541791 Department of Psychology PD Hahn Building University of Cape Town
City Postal code Country Position/Affiliation
Cape Town 7946 South Africa Researcher
REPORTING
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