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.: PACTR20180774832663 Date of Approval: 26/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title An Evaluation of the Effectiveness of a Community-Based Parenting Empowerment Program to Improve Nurturing Care of Young Children in Kenya and Zambia.
Official scientific title An Evaluation of the Effectiveness of a Community-Based Parenting Empowerment Program to Improve Nurturing Care of Young Children in Kenya and Zambia.
Brief summary describing the background and objectives of the trial Background: Investing in parents and children during the critical period between birth and five years of a child’s life can have long-lasting benefits in the life of the child. Recently, the 2016 Lancet Series estimated that 250 million children aged less than five years in low- and middle-income countries (LMICs) are at risk of not reaching their developmental potential. Over 66 % of these, who live in sub-Saharan Africa and are at risk due to poor nutrition, exposure to poverty, high HIV prevalence as well as under stimulation in the home environment. Episcopal Relief & Development and its partner organization in Kenya are implementing a community-based, integrated Early Childhood Development program. The integrated program addresses nurture and stimulation of under three children, child and maternal/family health, nutrition, and livelihoods issues through a combination of direct project activities and linking with available services. Objective: The purpose of the study is to build evidence for a high impact, cost-effective parenting empowerment model for scaling up as well as contribute to the evidence base and learning in the ECD sector’s nurturing care framework for children aged 0-3 years, focusing on parenting responsive care. The study seeks to establish the level of engagement of faith leaders, ECD volunteer effectiveness, parenting attitudes and behavior change on responsive care and stimulation, primary caregiver well-being, primary caregiver savings and loans group participation, and parenting behavior change on essential health and nutrition actions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/03/2018
Actual trial start date 11/06/2018
Anticipated date of last follow up 15/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 528
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Parenting empowerment 48 months The specific parenting interventions comprise: 1) Primary Caregiver Support & Learning Groups: these are facilitated by trained ECD volunteers, with monthly meetings for participatory learning for adoption of nurturing care parenting practices. Using parenting curricula which include picture-based dialogues, participants learn activities they can do with their children to promote children’s cognitive, language, motor skills, social and emotional development. Sessions also focus on practicing positive discipline techniques and reducing harsh punishment. The members also share their experiences and provide support and problem-solving for common parenting challenges. 2) ECD Home Visits are facilitated by ECD Volunteers, to reinforce nurturing care from the group work, particularly in the practice of responsive caregiving, early stimulation and positive discipline, and to provide individual support and problem-solving, providing caregivers confidentiality to raise specific issues. 3) Referrals and connections to other services for families in the areas of health, nutrition and other basic needs. 4) Economic strengthening support through training to caregiver groups to form self-managed savings and loan groups. 264
Control Group Parental empowerment 48 Government health care services 264 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All primary caregivers of children aged between zero and twelve months participating in the intervention program will be eligible for inclusion in the evaluation study. Families in the intervention program are selected on the basis of their vulnerability status (for example, health and nutrition indicators, HIV exposure, poverty levels). They will be long-term residents (more than one year) of the study area. Any short-term residents (less than one year) will be excluded from the study. Caregivers of children above the age of three years will also be excluded from the study. Also excluded will be women (or men) incapable of providing consent (e.g. those with mental impairments) Infant: 0 Month-23 Month,New born: 0 Day-1 Month 0 Month(s) 13 Month(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 06/06/2018 AMREF ESRC
Ethics Committee Address
Street address City Postal code Country
30125 Nairobi Kenya Nairobi 00100 Kenya
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 31/07/2018 ERES Zambia
Ethics Committee Address
Street address City Postal code Country
33 Joseph Mwilwa Road Rhodes Park, Lusaka Lusaka 00033 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes for the outcome evaluation will include level of engagement of faith leaders, ECD volunteer effectiveness, parenting attitudes and behavior change on responsive care and stimulation, primary caregiver well-being, primary caregiver savings and loans group participation, parenting behavior change on essential health and nutrition actions At the baseline, midline and endline at an interval of 9 months
Secondary Outcome The secondary outcome will be child developmental outcomes At baseline, midline and endline at an interval of 9 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
African population health and research centre 2nd Floor Manga Close, Off Kirawa Road Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Episcopal Relief and Development 815 Second Avenue New York, NY New York 10017 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor APHRC Manga Close, Off Kirawa Road Nairobi 00100 Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Zambian Anglican Council Outreach Programmes Plot No Sub Division A Lot 1846/M Third Street, Ibex Hill Lusaka Zambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Patricia Wekulo pwekulo@aphrc.org 722205933 Manga Close, Off Kirawa Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Post doctoral fellow
Role Name Email Phone Street address
Scientific Enquiries Silas Onyango sonyango@aphrc.org 722205933 Manga Close, Off Kirawa Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Research officer
Role Name Email Phone Street address
Public Enquiries Kenneth Okelo kokelo@aphrc.org 722205933 Manga Close, Off Kirawa Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Research officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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