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.: PACTR202103514565914 Date of Approval: 26/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Development and Evaluation of an Integrated Early Child Development Intervention in Urban Informal Settlements of Nairobi, Kenya.
Official scientific title Development and Feasibility Testing of an Integrated Intervention to Improve Early Child Development among Native Kenyans and Embedded Refugees in Informal Settlements of Nairobi: A Study Protocol.
Brief summary describing the background and objectives of the trial Children and families in urban informal settlements face a myriad of challenges, including poverty, caregivers’ poor mental health, inadequate cognitive stimulation, malnutrition and violence, that can elevate the risk for sub-optimal early childhood development (ECD). Due to their complexity, coupled by a dearth of intervention research on ECD in such settings, urban informal settlements present a context with an urgent need for implementation research so as to identify feasible and cost-effective intervention packages to counter the existent risks for sub-optimal childhood outcomes. This study aims to develop an integrated Early Child and Development (ECD) parenting intervention aligned with the global WHO-UNICEF Nurturing Care Framework. Specifically, the study aims to: (1) Identify, translate and pre-pilot a set of culturally responsive ECD parenting interventions for use in informal settlements within Dagoretti sub-county and its environs, and (2) Evaluate the acceptability and feasibility of implementing an integrated ECD parenting intervention among native Kenyans and embedded refugees. We are planning a two-phase study. In the first phase of the study, we will have a series of activities to develop and pilot-test a set of integrated ECD interventions. In the second phase, we will evaluate these interventions in a pilot cluster randomized controlled trial (cRCT) to generate preliminary data on feasibility, acceptability and response to intervention. We are designing a pragmatic cRCT where we will select 20 villages using a purposive strategic approach, ensuring that 10 of these feature a particularly high density of embedded refugees. Randomization will be done at village level, with 10 villages allocated to the treatment group and 10 villages allocated to an enhanced care group. We will target 8- 12 participants per village.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CDMC
Disease(s) or condition(s) being studied Early Child Development
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Integrated early child development and parenting intervention
Anticipated trial start date 04/01/2021
Actual trial start date 02/02/2021
Anticipated date of last follow up 30/12/2021
Actual Last follow-up date 31/03/2022
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 240
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 randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Integrated early child development and parenting intervention programme Intervention arm attend monthly community sessions by trained community health volunteers (CHVs)/facilitators at pre-natal and post-natal phase - total of 8 community sessions. Monthly home follow-up visit - at least 8 visits during 12 months period Consenting partners of expectant women in the intervention arm receive weekly short-text messages on parenting (SMS4babb) during pregnancy and post-natal. 12 months Trained CHVs will then be allocated to groups of mothers with whom each will administer the group sessions and carry out home visits. Based on the module requirements, CHVs will schedule visits with each participant in their groups to discuss and train them on the specific activities. SMS4Baba will be administered using mobile text format. 120
Control Group Enhanced care Monthly home visits or telephone call by a trained community health volunteer/facilitator 12 months Community health volunteers (CHVs) in the enhanced care arm will be required to pay a monthly visit to the home or make a call to all participants in their groups to check on: the child’s health, confirm that the parent is attending all the prenatal clinics as recommended by the Ministry of Health Kenya, and refer them to seek care when needed. If the intervention is shown to have positive outcomes, as expected, CHVs from the control group will be trained in its administration and encouraged to apply the intervention content in their work with control families to ensure that these families also have direct benefit of the intervention. 120 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The participants from the 20 selected villages will be included if: (1) they are pregnant women in their last trimester (6 – 9 months); (2) participants provide written informed consent; (3) the family resides in Dagoretti region for the past 6 months and intention to stay within Dagoretti at least 12 months post-recruitment. (4) male partner to the pregnant woman in the intervention arm will be approached to enroll in the mobile health intervention (SMS4baba). - No written informed consent - Resides outside study allocated villages Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 01/07/2019 Aga Khan University Social Science and Humanities Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Stadium Road Karachi 3500 Pakistan
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 26/07/2019 National Commission for Science Technology and Innovation
Ethics Committee Address
Street address City Postal code Country
Upper Kabete 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 02/07/2020 Aga Khan University Social Science and Humanities Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Stadium Road Karachi 3500 Pakistan
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 15/03/2021 National Commission for Science Technology and Innovation
Ethics Committee Address
Street address City Postal code Country
Waiyaki Way Upper Kabete Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Child developmental outcomes, parenting behavior and caregiver mental health Baseline, midline and endline
Secondary Outcome Process evaluation to assess the feasibility, acceptability, fidelity of implementing an integrated early child development and parenting intervention in an urban informal settlement context. Throughout the study period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institute for Human Development field office Tunza Plaza building, Kawangware - along Naivasha Road Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
International Development Research Centre Ottawa Ontario Canada
Aga Khan Foundation Canada 199 Sussex Drive Ottawa Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University Park Place, Second Parklands Avenue Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Lunenfeld Tanenbaum Research Institute 600 University Avenue Toronto Kenya
Institute for Human Development Aga Khan University 6 Peponi Road Westlands Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amina Abubakar amina.abubakar@aku.edu +254203661200 6 Peponi Road Westlands
City Postal code Country Position/Affiliation
Nairobi Kenya Director Institute for Human Development
Role Name Email Phone Street address
Scientific Enquiries Steve Lye LYE@lunenfeld.ca +416586480082 25 Orde Street
City Postal code Country Position/Affiliation
Toronto Canada Senior Investigator and Associate Director
Role Name Email Phone Street address
Public Enquiries Margaret Kabue margaret.kabue@aku.edu +254780441834 6 Peponi Road Westlands
City Postal code Country Position/Affiliation
Nairobi Kenya Programme Manager Institute for Human Development and CDMC project coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymized data and in summary form will be available and published through open-access peer reviewed journals. Interventions that are not open access such as SMS4Baba, we are using in our integrated ECD and parenting programme with the understanding that the intellectual property rights remain with the original developers. Study Protocol 2 years Controlled access and permission has to be obtained by contacting the study principal investigator and permission for re-use obtained from the granting scientific and ethics review board
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