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.: PACTR201610001267268 Date of Approval: 14/09/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Malezi ne Kilimo Bora Skilful Parenting and Agribusiness Child Abuse Prevention Study
Official scientific title Skilful Parenting and Agribusiness Child Abuse Prevention Study
Brief summary describing the background and objectives of the trial The Malezi ne Kilimo Bora (¿Good Parenting and Farming¿ in Kiswahili) Skilful Parenting and Agribusiness Child Abuse Prevention Study is a collaboration between the University of Oxford, University of Glasgow, and the Tanzania National Medical Research Institute (NIMR). It is pilot cluster randomised controlled trial (cRCT) of a community-based intervention implemented by Investing in Children and Our Societies (ICS), an international NGO with extensive experience operating in rural Tanzania. The overall focus of the project is to evaluate ICS¿s agribusiness and skilful parenting programmes¿ impact on the prevention of child maltreatment and improvement of child and family psychosocial and economic wellbeing. Thus, the pilot study will serve the following purposes: 1) to evaluate the feasibility of the ICS model that combines Agribusiness and Skilful Parenting in terms of reach and implementation fidelity as well as the components separately; 2) to understand the mechanisms by which parents and program facilitators perceive how the parenting program influences parenting behaviour; 3) to generate preliminary evidence of the integrated model¿s impact in comparison to Skilful Parenting only, Agribusiness only, and a wait-list control group; 4) to understand how economic strengthening programs combined with parenting support reduce the risk of violence against children; 5) to examine participating families¿ existing needs for early childhood development and the Skilful Parenting program¿s potential benefits for improving responsivity, acceptance, cognitive stimulation, and involvement. 6) to evaluate the feasibility of conducting a larger multi-armed cluster RCT in rural Tanzania in preparation for a larger trial.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) sPACAPS
Disease(s) or condition(s) being studied Paediatrics,Violence against children
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/09/2015
Actual trial start date 01/09/2015
Anticipated date of last follow up 28/11/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 247
Recruitment status Recruiting
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 Simple randomisation using a radomisation table created by a computer software program An external researcher not directly involved in the study performed random allocation from a remote site in Cape Town, South Africa Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No intervention 80 Active-Treatment of Control Group
Experimental Group Skilful Parenting 12 sessions 6 months The Skilful Parenting programme is a ICS-run parent-support programme that reinforces positive parenting practices, empowering parents to address the challenges that they face in bringing up their children. Skilful Parenting is a 12 session group-based parenting programme involving weekly sessions with caregivers who are members of farmer groups. Under guidance of a professional facilitator, the p 78
Experimental Group AGRICS Ongoing 6 months AGRICS is an independent non-governmental organisation with the overall objective to contribute to lasting social and economic empowerment of farming communities in order to improve child wellbeing. AGRICS provides smallholder farmers, organized in farmer groups, with access to farm inputs on a credit basis (maize, sunflower or vegetable seeds and fertilizers), and agricultural extension and advis 75
Experimental Group AGRICS+Skilful Parenting Combined 6 months Combined AGRICS and Skilful Parenting interventions 66
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Villages: 1. Situated within 1 hour driving distance from Shinyanga; 2. Provide community consent via community local leader and approval from local authorities; 3. Contain registered farmer groups Farmer Groups: 1 Situated within participating village 2 Registered with Tanzanian Ministry of Agriculture within the previous 12 months; 3.Registered to participate in ICS¿s Agribusiness and Skilful Parenting programme; 4.Provide consent via farmer group leader Adults: 1.Age 18 or older 2.Serves as the primary caregiver of a child in the household between the ages of 3 and 17 3.Lives in the house at least 4 nights per week. 4.Is a registered member of the included agricultural farmer group 5.Provides consent to participate in the full study Children 1. Age 10 to 17 years at initial assessment 2. Lives in the house at least 4 nights per week 3. Must have an adult primary caregiver who lives in the household, who provides consent, and who participates in the study 4. Provides assent to participate in the full study Adults: 1. Any adult exhibiting severe mental health problems or acute mental disabilities. 2. Any adult that has been referred to social services or child protection services during the course of baseline data collection as a result of reported or observed indications of significant potential psychological harm towards a child. Children: 1. Any child who is either experiencing severe mental health problems, has acute developmental disabilities, 2. If the child participant has been referred to social services during baseline data collection due to reported or observed indications of significant harm 18 Year(s) 120 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 24/09/2015 University of Oxford Social Sciences and Humanities Inter-divisional Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Wellington Square Oxford OX1 2ER 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 03/09/2015 Lake Zone Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
National Institute for Medical Research Mwanza N/A Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Child maltreatment - ICAST Baseline Mid-treatment assessment Post-treatment assessment
Primary Outcome Attitudes towards corporal punishment Baseline Mid-treatment assessment Post-treatment assessment
Primary Outcome Parenting behaviour Baseline Mid-treatment assessment Post-treatment assessment
Secondary Outcome Parenting stress Baseline Mid-treatment assessment Post-treatment assessment
Secondary Outcome Parental depression Baseline Mid-treatment assessment Post-treatment assessment
Secondary Outcome Child behaviour problems Baseline Mid-treatment assessment Post-treatment assessment
Secondary Outcome Child depression Baseline Mid-treatment assessment Post-treatment assessment
Secondary Outcome Child sexual behaviour Baseline Mid-treatment assessment Post-treatment assessment
Secondary Outcome Child labour Baseline Mid-treatment assessment Post-treatment assessment
Secondary Outcome Intimate partner violence Baseline Mid-treatment assessment Post-treatment assessment
Secondary Outcome Early childhood home environment Baseline Mid-treatment assessment Post-treatment assessment
Secondary Outcome Child development Baseline Mid-treatment assessment Post-treatment assessment
Secondary Outcome Child nutrition Baseline Mid-treatment assessment Post-treatment assessment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Village Uhuru Road Shinyanga N/A Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
UBS Optimus Foundation Aeschenvorstadt 1 Basil 4051 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Department of Social Intervention 32 Wellington Square Oxford OX1 2ER United Kingdom University
Secondary Sponsor National Institute of Medical Research Mwanza Medical Research Centre Mwanza N/A Tanzania University
Secondary Sponsor University of Glasgow 200 Renfield St Glasgow G2 3QB United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Jamie Lachman 32 Wellington Square Oxford OX1 2ER United Kingdom
Frances Gardner 32 Wellington Square Oxford OX1 2ER United Kingdom
Joyce Wamoyi Mwanza Medical Research Centre Mwanza N/A Tanzania
Danny Wight 200 Renfield St Glasgow G2 3QB United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frances Gardner frances.gardner@spi.ox.ac.uk +44(0)1865 270325 32 Wellington Square
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom Professor
Role Name Email Phone Street address
Public Enquiries Joyce Wamoyi j.wamoyi@gmail.com +255 789 559 337 Mwanza Medical Research Centre
City Postal code Country Position/Affiliation
Mwanza N/A Tanzania Co-Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Jamie Lachman jamie.lachman@spi.ox.ac.ul +44(0)1865 270325 32 Wellington Square
City Postal code Country Position/Affiliation
Oxford OX1 2ER United Kingdom Research Associate, Co-Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 06/10/2016 Not uploaded on system s Malezi ne Kilimo Bora Skilful Parenting and Agribusiness Child Abuse Prevention Study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 06/10/2016 Not uploaded on system s Skilful Parenting and Agribusiness Child Abuse Prevention Study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 06/10/2016 Not uploaded on systgem s The Malezi ne Kilimo Bora (¿Good Parenting and Farming¿ in Kiswahili) Skilful Parenting and Agribusiness Child Abuse Prevention Study is a collaboration between the University of Oxford, University of Glasgow, and the Tanzania National Medical Research Institute (NIMR). It is pilot cluster randomised controlled trial (cRCT) of a community-based intervention implemented by Investing in Children and Our Societies (ICS), an international NGO with extensive experience operating in rural Tanzania. The overall focus of the project is to evaluate ICS¿s agribusiness and skilful parenting programmes¿ impact on the prevention of child maltreatment and improvement of child and family psychosocial and economic wellbeing. Thus, the pilot study will serve the following purposes: 1) to evaluate the feasibility of the ICS model that combines Agribusiness and Skilful Parenting in terms of reach and implementation fidelity as well as the components separately; 2) to understand the mechanisms by which parents and program facilitators perceive how the parenting program influences parenting behaviour; 3) to generate preliminary evidence of the integrated model¿s impact in comparison to Skilful Parenting only, Agribusiness only, and a wait-list control group; 4) to understand how economic strengthening programs combined with parenting support reduce the risk of violence against children; 5) to examine participating families¿ existing needs for early childhood development and the Skilful Parenting program¿s potential benefits for improving responsivity, acceptance, cognitive stimulation, and involvement. 6) to evaluate the feasibility of conducting a larger multi-armed cluster RCT in rural Tanzania in preparation for a larger trial.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 10/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 06/10/2016 Not uploaded on system 2015-09-01
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 06/10/2016 Not uploaded on system 247
Section Name Field Name Date Reason Old Value Updated Value
Ethics CommitteeName 06/10/2016 Not uploaded on system IssuingAuthority IssuingAuthority
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 06/10/2016 Not uploaded on system child Maltreatment and Economic Strengthening Violence against children
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 10/07/2018 pactr update Other Paediatrics, Other
Section Name Field Name Date Reason Old Value Updated Value
Study Design Masking / blinding 07/10/2016
Section Name Field Name Date Reason Old Value Updated Value
Study Design Masking / blinding 07/10/2016 Open-label (masking not used) Masking/blinding used
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 06/10/2016 Not uploaded on system SECONDARY_ID SECONDARY_ID