Jeong et al. BMC Pediatrics(2024) 24:592
https://doi.org/10.1186/s12887-024-05065-7

BMC Pediatrics

S T U DY P R OTO CO L

Open Access

A parenting program delivered throughexisting community-based peer groups
to improve early child developmentin Homabay and Busia Counties, Kenya: study
protocol for a cluster-randomized controlled
trial
Joshua Jeong1*, Juliet K. McCann1, Silas Onyango2 and Michael Ochieng3
Abstract
Background Poor early childhood development (ECD) is a major global health concern that is associated withvarious adverse outcomes over the lifecourse. Parenting interventions especially during the earliest years of life canbenefit ECD. However, there is limited evidence from Kenya about the effectiveness of parenting interventions for
improving ECD outcomes especially across rural disadvantaged communities. This paper describes the study protocol
for an impact and implementation evaluation of a community-based group parenting program that aims to improve
ECD in rural Kenya.
Methods We will conduct a cluster-randomized controlled trial to determine the effectiveness of a parenting
program for caregivers of young children in Homabay and Busia counties in Western Kenya. Sixty-four village clusters
will be randomly assigned to either the parenting intervention arm or the waitlist control arm with stratification bycounty. In each village, 10 primary caregivers with a child aged 0–24 months will be enrolled. The parenting program
will be delivered through existing peer groups within communities whereby caregivers will receive counseling andpsychosocial support to enhance their parenting skills and wellbeing to in turn promote ECD. The intervention
curriculum comprises 21 sessions targeting various nurturing care messages, including early learning, responsive
caregiving, child nutrition, health, protection, and caregiver mental health. Group sessions are facilitated by a trained
volunteer biweekly for a total of 11 months. The primary trial outcome is an overall measure of ECD using the Global
Scales of Early Development long form version. Secondary outcomes include various caregiver outcomes (e.g.,parenting practices, mental health) and other child outcomes (e.g., socioemotional development, dietary diversity). All
outcomes will be assessed at baseline and endline. We will also conduct a qualitative implementation evaluation at
endline and interview various stakeholders to assess program fidelity, quality, and sustainability.

*Correspondence:
Joshua Jeongjoshua.jeong@emory.edu
Full list of author information is available at the end of the article© The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0
International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you
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Jeong et al. BMC Pediatrics(2024) 24:592

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Discussion This trial will evaluate the effectiveness of a parenting intervention on ECD and caregiving outcomes
and assess program implementation quality as delivered through existing community-based peer groups. This study
will provide rigorous evidence that can be used to inform scale-up of this program model that leverages existing
community social networks and resources for improving caregivers’ parenting skills and promoting ECD in rural Kenya
and other similar settings across LMICs.
Trial registration ClinicalTrials.gov #NCT06165315. Registered on December 11, 2023.
Keywords Early child development, Parenting, Intervention, Randomized controlled trial, Kenya

Background
It has been estimated that 250 million or approximately
43% of children under five years are at risk of not attaining their developmental potential [1]. Poor early childhood development (ECD) is associated with a host ofadverse outcomes later in life – spanning health, education, psychosocial wellbeing, and economic productivity[2]. Various factors can contribute to poor ECD, including poverty, malnutrition, and sub-optimal parenting
practices [3, 4]. Nurturing care interventions that addressthese risk factors while bolstering protecting factors suchas early learning opportunities and responsive caregiving
are critical for promoting healthy ECD [5].
One of the most effective strategies for improving ECD
outcomes globally are parenting interventions [6]. Parenting interventions are social and behavioral programs
intended to improve primary caregivers’ knowledge, attitudes, practices, and skills to support children’s development. Parenting interventions often target multiple
behaviors such as increasing engagement in stimulation
activities, promoting attachment and parental sensitivity
and responsiveness, providing access to toys and othermaterials for play and learning, supporting positive disciplinary practices [7]. Furthermore, parenting interventions are increasingly being integrated with othernurturing care messages – such as nutrition, health, caregiver wellbeing, and gender – to achieve more holistic
impacts for caregivers and young children [8, 9].
Although there has been a rapidly growing evidencebase on the effectiveness of parenting interventions inlow- and middle-income countries (LMICs), the majority of the global evidence is concentrated to a select subset of countries. For example, a global meta-analysis ofparenting interventions revealed that most randomized
controlled trials (RCTs) of parenting interventions in
LMICs have been conducted in Bangladesh, Jamaica, andIndia [7]. There are relatively fewer rigorous evaluationsof parenting interventions from countries in sub-SaharanAfrica.
Specifically in Kenya, less than a handful of publications to date have evaluated the impacts of parenting
interventions on ECD outcomes [10–12]. While thisprior evidence has suggested benefits on certain caregiver-level outcomes (e.g., parenting knowledge andpractices), program impacts on ECD outcomes have been
more mixed with two studies finding null effects [10, 12]
and one study observing improvements in child development [11]. One key limitation of this overall evidencebase from Kenya pertains to questions of internal validity and specifically the lack of random assignment to theprogram, with only one of these prior studies using anexperimental design [11].
This nascent and inconclusive evidence base underscores the need for additional research and particularly
using robust study design to determine the effectiveness of parenting interventions relative to standard-ofcare services for improving ECD in Kenya. In addition
to impact evaluations, implementation evaluations canuncover additional insights regarding the successful
ingredients of parenting programs, stakeholders’ experiences participating in the program, the barriers andenablers to program delivery, and potential for scalability [13–15].This paper describes the study protocol
for a combined impact and implementation evaluationof a community-based group parenting program for
improving ECD in rural Kenya. The intervention modelis unique by leveraging existing community-based peergroups and integrating parenting support within these
networks. This mixed-methods evaluation will provide aholistic understanding regarding whether, why, and how
the parenting program benefits ECD and caregiving outcomes. Study findings are expected to inform programmatic adaptations and actionable recommendations forenhancing the effectiveness, quality, and implementationof parenting programs in rural Western Kenya and othersimilar settings across LMICs.

Methods
Study design

This study design comprises a quantitative impact evaluation and a qualitative implementation evaluation. To
quantitatively evaluate the effectiveness of the parenting intervention on ECD and caregiving outcomes, wewill use a cluster-RCT design. Villages will be randomly
allocated at a 1:1 ratio to either the parenting intervention arm or a waitlist, standard-of-care control arm.
In each village, 10 primary caregivers with a child aged
0–24 months will be enrolled. We will conduct two

Jeong et al. BMC Pediatrics(2024) 24:592

rounds of data collection in the study cohort at baseline
and endline (i.e., immediately after the completion of theintervention, or a follow-up period of 11 months after
baseline) to compare changes in outcomes between study
arms and over time. After the endline evaluation is completed, then the villages in the waitlist-control arm will
have the opportunity to receive the parenting program.
To evaluate the implementation quality of this parenting
program, we will incorporate a qualitative study as partof the endline evaluation and conduct in-depth interviews with various stakeholders to assess how factors
such as program fidelity, quality, and acceptability influence program impacts on caregivers, children, and theircommunities. The trial is registered with ClinicalTrials.
gov, #NCT06165315.
Study setting and enrollment

The trial will be conducted in Homabay and Busia counties in Western Kenya. In both counties, households are
generally poor with the majority falling in the lowest two
wealth quintiles relative to national distributions, and the
predominant occupation being agriculture [16]. Homabay county the has the highest prevalence of HIV (20%)
and proportion of children who are double orphans (3%)
in the country [16, 17]. These counties were selected byprogram implementation and county government partners based on these county governments’ commitments
to improving the quality and access to maternal, childand adolescent health, nutrition, and early childhood
education services. Busia and Homabay counties wereidentified by stakeholders as having inadequate information on nurturing care and the science of ECD, nothaving policies that anchor nurturing care, and not having prioritized allocation of funds for ECD. They werealso identified as having weak stand-alone coordination
structures that are department specific. Together thishighlighted a key gap in these counties but also an opportunity for programming.
In consultation between ChildFund (i.e., the lead
implementing organization) and its partners that
included subnational government ministry representative, local community-based organization partners, andlocal community members, specifically Ndhiwa subcounty in Homabay County and Bunyala sub-county in
Busia County were prioritized as the project sites. The
teams used health and vulnerability criteria to prioritize
locations. The criteria included: locations with a high rateof HIV and AIDS, teenage pregnancy, pregnant mortality, neonatal mortality, malnutrition, anemia and stunting, inadequate access to supplements and vitamins,child marriage and early pregnancy, as well as low accessto health services such as pre-and post-natal services andlow rates of birth registration. In Ndhiwa sub-county in
Homabay county, the study will be conducted specifically

Page 3 of 9in all 3 wards (North Kabuoch, Kanyamwa Kosewe, Kanyamwa Kologi). In Bunyala sub-county in Busia County,
the study will be conducted in 3 out of the 4 wards (Bunyala North, Bunyala South, Bunyala West). This samplingframe and setting was determined by the program teamduring the planning phase through consultations withstakeholders and prior to the initiation of the research
partnership.
Based off of the set plans for program implementationin 6 wards (3 in Bunyala sub-county and 3 in Ndhiwa
sub-county), we obtained lists of all the villages and theestimated number of households per village across theseselected wards. Villages with extreme accessibility challenges (e.g., islands) or those with relatively few households (i.e., less than 70 households per villages) were
excluded for operational feasibility. From the remaining
villages, we randomly selected 64 total villages with stratification by ward (approximately 10 villages per ward)
and randomly assigned half to the intervention versus
waitlist control (approximately 5 villages in the intervention vs. control per ward). We replaced any sampled
villages that were neighboring with another randomly
selected villages from the list of eligible villages. Final
selection of villages was be made by the research team incollaboration with the implementing partner to ensure
representation of the ward, feasibility of the site, while
reducing the risk of contamination.
Eligibility criteria and recruitment

Once villages are selected, the research team willapproach households to screen caregivers for eligibility.
Study eligibility criteria will include: primary caregivers
with a child aged 0–24 months, the household resides inthe sampled village, and the primary caregiver provides
informed consent for themselves and their child to participate. Only one caregiver will be sampled per household for a total of 10 caregivers per village.
For the qualitative implementation evaluation, we will
focus on a sub-sample of intervention villages and use
purposive sampling to recruit caregivers, program delivery agents, other community stakeholders (e.g., community health volunteers), and program staff to capture adiversity of perspectives and experiences with respect tothe program implementation.
Intervention description

This parenting program was developed by ChildFund
International with implementation being overseen byChildFund Kenya. ChildFund is a non-governmentalorganization that works in 24 countries in Africa, including Kenya, as well as Asia, and the Americas to improve
the lives of children living in poverty, bring positivechange to their communities, and create societies thatvalue, protect, and advance child rights and wellbeing.

Jeong et al. BMC Pediatrics(2024) 24:592

The primary goal of this parenting program is to improve
caregivers’ knowledge, attitudes, and practices about
nurturing care to in turn improve the developmental outcomes of young children aged 0–3 years. The primary
program component are the community-based parenting group sessions. Parenting groups leverage existing
peer-groups in the community (e.g., self-help groups,
microfinance groups, women’s groups) to bring together
10 eligible caregiver-child dyads per group. Group sessions are facilitated by one trained volunteer who either
was nominated as the peer group leader among theexisting group members or already serves in the capacity of a community focal person (e.g., community healthpromoters, community child protection volunteers, village elders). These group leaders will receive supportive
supervision from a mentor. The manualized intervention
curriculum includes 21 sessions and covers various content with respect to the Nurturing Care Framework for
promoting ECD, including play and communication withyoung child, responsive caregiving, child health, nutrition, protection, and caregiver wellbeing [18]. Sessions
focus on enhancing social and behavior change throughcounseling, participatory activities, problem-solving, andgroup discussion. Each group session is expected to last
up to 2 h and at a frequency of every two weeks (i.e., 2

Fig. 1 ChildFund parenting program theory of change

Page 4 of 9sessions per month) for a total implementation durationof approximately 11 months.
In addition to the universal group parenting program
component, the program will provide targeted psychosocial support (e.g., referrals to health facilities for caregivers with mental health problems) and livelihood support(e.g., training on income-generating activities, provisionof agricultural inputs) to a subsample of caregivers atgreatest risk of adversity. In addition to supporting caregivers directly, the program will also strengthen existing
community systems to promote enabling environment
for nurturing care. The program will strengthen linkages with existing community-level maternal and childhealth and nutrition services through conducting trainings to group facilitators about maternal and child healthand nutrition in collaboration with Ministry of Healthat the subcounty level, strengthening referral channels,
and improving coordination with community healthvolunteers and other health professionals (e.g., healthfacility staff, nutritionists). Finally, the program will also
promote capacity development of local implementing
organizations and child protection agencies to enhance
local ownership and build multisectoral coordination for
nurturing care at the subnational and national levels. See
Fig. 1 for theory of change to the ChildFund parenting

Jeong et al. BMC Pediatrics(2024) 24:592

program that guides the main outcomes for the effectiveness evaluation.
ChildFund Kenya will direct the overall program implementation through designing the program materials,
leading technical trainings and supportive supervision
for partners, and conducting routine program monitoring activities. Community-level program activities will be
implemented by the Lake Region Development Program(LRDP) in Ndhiwa Sub-County and the Western Community Children’s Programme (WCCP) in Bunyala SubCounty. ChildFund and community partners will engage
relevant government stakeholders through ongoingtraining activities and multisectoral advocacy meetings
to build capacity for implementing nurturing care activities and local ownership of the program. Implementation
for the first parenting group session is expected to begin
by end of January 2024, and program implementation forthis first cohort is expected to be completed by November 2024.
Randomization and blinding

A total of 64 villages were randomly allocated at a 1:1
ratio using computer-generated random numbers in
Stata 16 to either the parenting intervention arm or a
waitlist, standard-of-care control arm with stratification by wards to ensure balance between sub-counties.
Randomization was done prior to study initiation by aresearcher at Emory University who was not involved instudy procedures. Due to the nature of the communitybased social and behavior change intervention, it is notpossible to blind participants or the implementationteam to the intervention group assignment. Survey enumerators and data analysts will be blinded to treatmentgroup assignment.
Outcomes measures

Enrolled primary caregiver-child dyads will be assessed ina private setting at the caregiver’s household. We will collect detailed information on various characteristics spanning sociodemographic factors, caregivers’ knowledge,
attitudes, and practices related to parenting, caregivers’
mental health, and child development. See Table 1 fordetails of the trial primary and secondary outcome measures that will be assessed at both baseline and endline
data collection. The primary endpoint will be at endline(i.e., following the implementation of the 11-month intervention). Survey questionnaires will be administered bytrained enumerators to primary caregivers in their preferred language of Kiswahili, Luo, or Luhya, and data will
be collected electronically using tablets (Kobotoolbox).
The primary outcome of this trial is children’s overall development, which will be measured using the longform version of the Global Scales of Early Development (GSED) [19]. The GSED is a direct observational

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assessment of ECD whereby a trained research assistantconducts a series of activities to observe a child’s developmental skills. The GSED provides one overall score ofchild development based on a variety of skills pertaining
to cognitive, language, and motor development. Considering that the GSED is a relatively new tool that has
not been validated previously in Western Kenya, we will
analyze our baseline data to assess the reliability, validity, and appropriateness of the GSED for use in our study
context. While we will set GSED as the primary outcome
measure for child development, we will assess ECD at
endline using two tools – not only the GSED but also
the Caregiver Reported Early Development Instruments(CREDI) long form version that has been previously usedin Western Kenya [20] – to corroborate study results
using another outcome measure and one that can provide
domain-specific effects, as GSED only provides an overall
holistic score for ECD. Thus, CREDI will be measured asa secondary outcome measure.
Other secondary outcome measures will include primary caregivers’ parenting (e.g., stimulation, disciplinary practices) and psychosocial wellbeing outcomes (e.g.,
depressive symptoms, parenting stress) that are conceptualized as intermediary outcomes in the program theoryof change towards ultimately impacting ECD. In addition
to the CREDI-long form version as an alternate tool for
ECD, we will also assess children’s socioemotional development. Research assistants will observe and provide ratings of children’s socioemotional development using an
adapted version of the Wolke Scales [21].
Finally, we will also consider several exploratory outcomes that are addressed in the content of the parenting curriculum and relevant to the program theory ofchange. For example, child birth registration, child illness
and care-seeking, caregivers’ perceived social support,
perceived financial security, positive coping strategies
used, and father involvement.
Sample size calculation

We conducted a sample size calculation for a minimum
detectable difference of 0.3 SD in the primary outcomeof ECD over a 11-month period between the intervention
and control group. With a power of 0.8, α = 0.05, an intraclass correlation coefficient (ICC) for clusters of 0.03, anaverage cluster size 10 (i.e., the intended number of caregivers per parenting group accordingly to the program
model), and a follow-up rate of 88%, the required numberof clusters is 32 per study arm. Thus, we will enroll a totalof 640 primary caregiver-child dyads (320 per study arm).
Qualitative implementation evaluation

In addition to the quantitative evaluation, we will conduct a qualitative implementation evaluation. The qualitative implementation evaluation will not only serve toJeong et al. BMC Pediatrics(2024) 24:592

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Table 1 Primary and secondary outcomes
Outcome measures
Primary outcome
Child development

Description
Child development measured using the Global Scales of Early Development - Long Form (GSED-LF). GSED-LF is based on
direct administration by a research assistant. GSED-LF provides one score for the overall development of children 0–36
months of age. GSED scores will be age-standardized to a mean of 0 and a standard deviation of 1. Higher scores will
indicate improved early developmental skills.

Secondary outcomesChild development

Caregiver-reported measure of child development using the Caregiver Reported Early Childhood Index (CREDI) – long form
version. The CREDI long form will provide separate domain-specific scores for children’s cognitive, language, motor, andsocioemotional development. CREDI scores will be age-standardized to a mean of 0 and a standard deviation of 1. Higherscores will indicate improved early developmental skills.
Child socioemotional
Child socioemotional development based on observational rating by a research assistant using an adapted version of thedevelopment
Wolke Scales (e.g., child affect, vocalization, cooperation with the research assistant). An average score will be calculated
across the items with higher scores indicating more positive child behaviors.
Attitudes towards
Primary caregivers will report the extent to which they agree with various statements about parental roles and engageparenting
ment in nurturing care practices. A total score will be calculated with higher scores indicating more supportive parenting
attitudes.
Caregiving environment Caregiving environment will be assessed using the Home Observation for Measurement of the Environment for infants andtoddlers aged 0 to 3 years (HOME-IT). It combines caregiver-reported items and observations of parenting behaviors toassess early learning opportunities at home and responsive caregiving behaviors of primary caregiver with the child. A total
score will be calculated with higher scores indicate more responsive caregiving and enriched home learning environments.
Caregiver stimulation
Caregiver stimulation practices reported by primary caregiver about their engagement in early learning activities with thepracticeschild (e.g., singing, telling stories). Activities adapted from the Family Care Indicators. A total score will be calculated withhigher scores indicating more engagement in stimulation activities.
Caregiver disciplinary
Caregiver disciplinary practices reported by primary caregivers in terms of harsh punishment (e.g., shook the child, shouted
practicesat child) and positive disciplinary practices (e.g., explained why the behavior was wrong) used towards the child. Items
adapted from Child Discipline Module of Multiple Indicator Cluster Survey. Separate indicators will be created for use of any
harsh disciplinary practices or any positive disciplinary practices.
Infant and young child
Infant and young child feeding (IYCF) practices including caregiver-reported breastfeeding and exclusive breastfeeding
feeding practices
practices and child dietary diversity score (number of food groups the child consumed in previous 24 h) based on WHO
guidelines.
Parenting stress
Parenting distress reported by the primary caregiver using the Parenting Stress Index-Short Form, Parental Distress subscale. Higher total scores indicate greater parenting distress.
Depressive symptoms
Depressive symptoms reported by the primary caregiver using the Centre for Epidemiological Studies Depression Scale-10
items (CESD-10). Caregivers report on the frequency of depressive symptoms in the previous week. Items are summed tocreate an overall depression score, with higher scoring indicating greater depressive symptoms.

triangulate quantitative findings about changes in outcomes, but also assess program fidelity; determine stakeholders’ satisfaction; understand the factors and contexts
that influence program effectiveness (i.e., what, why, how,for whom); explore potential underlying mechanismsof program impact on ECD outcomes; and investigate
potential sustainability and scalability of the program
model. This implementation evaluation will be conductedat endline after the completion of the program delivery.
We will conduct in-depth interviews various stakeholders involved in the implementation of the program:participating primary caregivers, parenting groups facilitators, other community-based delivery agents (e.g., community health volunteers, child protection volunteers),
program staff, and relevant government stakeholders. We
will also conduct a few focus group discussions with participating caregivers and parenting group facilitators. The
sample will be distributed across villages in both Bunyala
and Ndihwa sub-counties to capture a diversity of implementation experiences and a range of contexts.

Qualitative interview guides will assess various aspects
of program implementation. For example, questions inthe semi-structured interview guides will cover the fivedimensions of the RE-AIM framework: Reach, Effectiveness, Adoption, Implementation, and Maintenance [22].
We will also explore other key aspects like the degree ofmultisectoral coordination and systems strengthening
relating to nurturing care and ECD at the village and subcounty levels. Interviews will be conducted by trained
research assistants who are external to the program
implementation.
Statistical methods and analysis
Quantitative data analysis

To estimate the effectiveness of the intervention on study
outcomes, we will use mixed effects regression models to compare the difference in primary and secondary
outcomes between intervention and control arms overtime. We will use linear regression models for continuous outcomes and logistic regression models for binary

Jeong et al. BMC Pediatrics(2024) 24:592

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outcomes. We will run separate models for unadjusted
results versus adjusted results that control for baseline
covariates. All analyses will be estimated on an intentionto-treat basis. Missing data on covariates will be imputed
using multiple imputation. Missing data on outcome
variables will not be imputed. All hypothesis tests will be
two-sided with a 0.05 significance level. Analyses will be
conducted using the data analysis software Stata SE version 18.

participating caregivers and parenting group facilitators,
and other policy and advocacy stakeholders such as UNICEF. In addition to convening a dissemination event, we
will prepare evidence briefs summarizing the high-level
results, which we will tailor for different audiences (e.g.,
government, community leaders). The study team will
also present results at regional and international workshops and conferences on ECD and prepare manuscripts
for publication in peer-reviewed journals.

Qualitative data analysis

Discussion
The objective of this manuscript is to describe the trial
design and research protocol for a mixed-methods
impact and implementation evaluation of a communitybased group parenting program for primary caregiversof children 0–24 months of age in Busia and Homabay
counties in western Kenya. A novel aspect of the parenting intervention curriculum is how it is multicomponent
and holistically addresses nurturing care with a strong
focus on early learning and responsive caregiving, as wellas other topics including positive discipline, child healthand nutrition, and components that also directly target
caregivers’ psychosocial wellbeing. Another key strengthof the program implementation approach is how it leverages existing peer group networks within the community
to form parenting groups and delivering this program,rather than forming new peer groups for the sole purposes of this single program. Thus, this delivery approachhas greater potential for harnessing existing and trusted
relationship among community members, increasing
program acceptability, and for future program sustainability and scalability. A strength of this research is its
rigorous mixed-methods design that will jointly evaluate
the effectiveness of the program through a rigorous cluster-RCT design and qualitatively assess and triangulate
across various stakeholders’ perceptions regarding theimplementation of the program. Together, this combined
impact and implementation evaluation will illuminate acomprehensive understanding of the program attributable changes in caregiver and child-level outcomes aswell as the underlying reasons, conditions, and contextual factors that may have enabled or hindered program
delivery and success.
One key limitation of this study is that our impact
evaluation of the program model will primarily focus
on assessing the overall effectiveness of the parenting
curriculum and program activities associated with thegroup sessions, which is one piece of the overall program
model. In addition to manualized curriculum and theuniversal parenting group sessions, the program model
also includes some targeted services for caregivers andchildren facing additional risks (e.g., livelihood support
for the poorest families, psychosocial services for caregivers with mental health problems). However, our study

Qualitative data analysis will be collaborative among
study investigators and iterative using thematic content analysis. A codebook will be developed from thestudy objectives, research questions, and pilot interview
transcripts. The analysis team will conduct open coding of the interview transcripts and document emerging
themes using the qualitative data analysis software Atlas.
Ti. Major and minor themes along with their respective
sub-themes will be identified and continuously developed through consensus among all analysts. Key findings
will be organized with respect to the various stakeholders’ perspectives and dimensions of the implementation
evaluation.
EthicsThis study protocol received institutional review board(IRB) approvals from the Emory Rollins School of Public
Health (Protocol #: STUDY00006385) and the Jaramogi
Oginga Odinga Teaching and Referral Hospital – Institutional Scientific Ethics Review Committee (Protocol#: ISERC/JOOTRH/736/23). A research license was also
obtained for the study from the National Commission for
Science, Technology, and Innovation in Kenya (License#: NACOSTI/P/23/30039). Written informed consent
through signature or thumbprint was obtained from allparticipants in the quantitative evaluation. For any primary caregivers younger than 18 years, we obtained written assent from the adult caregivers or legal guardians of
the young caregiver. Informed consent/asset processes
will be obtained similarly for the qualitative implementation evaluation study. Study participants at each round ofdata collection will receive KES 400 (approximately $2.50
USD) as an appreciation for their participation. This
amount of compensation is in line with prior studies andwas determined in consultation with all study partners.
Dissemination plan

The study team will organize an in-person local dissemination event where we will share findings withvarious stakeholders of the project, including county
and subcounty ministries (e.g., directors of health, earlyeducation), other non-governmental organizations
implementing ECD programs in Kenya, academics,

Jeong et al. BMC Pediatrics(2024) 24:592

is not powered to detect program effects associated withthese targeted services that will be delivered to a subsample of the main program beneficiaries. Thus, we likely
will be unable to capture the full range of program effects(e.g., on caregivers’ financial security) and therefore willconsider a set of measures more as exploratory outcomes.
Nevertheless, our findings will inform future research
directions including whether a larger study should be
pursued. Additionally, although we had replaced somevillages during the sample selection process for being
contiguous with others belonging to another treatment
arm, villages particularly in Bunyala sub-county are relatively smaller and more geographically contained andnearer to one another than in Ndhiwa sub-county. Thereremains a possible risk across both sub-counties for contamination between the intervention and control villages
with a cluster-RCT study design and given the sampling
constraints set out at the project inception. We will
work together with the implementing partners to monitor this throughout the program rollout as well as in thequalitative implementation evaluation and incorporate
any information about potential contamination into ouranalysis.
In conclusion, our study will shed light on the effectiveness and implementation of this parenting programin Ndhiwa and Bunyala sub-counties in Western Kenya,
where to our knowledge a parenting program has notbeen evaluated previously. Our findings will directly
inform adaptations to the program model and approachas it continues to be scaled out across these sub-counties
in the coming years. These results will provide an important extension to the limited evidence base on community-based parenting programs for promoting ECD inrural Western Kenya and can also more broadly informresearch and programs in other similar low-resource settings globally.
Abbreviations
ECD	Early childhood development
GSED	Global Scales of Early Development
IRB	Institutional review board
LMIC	Low- and middle-income country
RCT	Randomized controlled trial
Acknowledgements
We thank implementing partners at ChildFund Kenya, ChildFund
International, Lake Region Development Program, and Western Community
Children’s Programme for their support with the planning and community
entry for this research. We thank Wilson Ochuka and the field supervisors andresearch assistants at B&M Consult for their efforts with data collection. We
thank the Conrad N. Hilton Foundation for providing funding for this study.
JJ is supported in part by a grant from the Eunice Kennedy Shriver National
Institute of Child Health and Human Development (R00HD105984).
Author contributions
JJ led the conceptualization, study design, methodology, study supervision,and drafted the manuscript. JKM contributed to study tools and project
administration. SO contributed to the study design and study tools. MO
contributed to the study design, management of participant recruitment, andPage 8 of 9

oversaw data collection activities. All authors reviewed and approved the final
manuscript.
Funding
This project is funded by the Conrad N. Hilton Foundation. The funder had
no role in the study design or data collection and will have no role in data
analysis, interpretation of results, or manuscript preparation.
Data availability
Upon completion of the study, the datasets used and/or analyzed during thecurrent study are available from the corresponding author upon reasonable
request and with a data sharing agreement.

Declarations
Ethics approval and consent to participate
This study protocol received ethics approvals from the institutional
review board (IRB) at Emory Rollins School of Public Health (Protocol #:STUDY00006385) and the Jaramogi Oginga Odinga Teaching and Referral
Hospital – Institutional Scientific Ethics Review Committee (Protocol #: ISERC/JOOTRH/736/23). A research license was also obtained for the study fromthe National Commission for Science, Technology, and Innovation in Kenya(License #: NACOSTI/P/23/30039). Written informed consent was obtained
through signature or thumbprint from all enrolled participants in the clusterRCT. Similarly, written informed consent will be obtained from all participants
enrolled into the qualitative implementation evaluation.
Competing interests
The authors declare no competing interests.
Consent for publication
Not applicable.
Author details
1
Hubert Department of Global Health, Rollins School of Public Health,
Emory University, Atlanta, GA, USA
2
African Population and Health Research Center, Nairobi, Kenya
3
B&M Consult, Nairobi, Kenya
Received: 20 March 2024 / Accepted: 6 September 2024

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