Testing Means to Scale Early Childhood Development Interventions in Rural Kenya
Phase: NA
Conditions: Early Child Development
Sponsor: University of Southern California

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Testing Means to Scale Early Childhood 
Development Interventions in Rural Kenya 
ClinicalTrials.gov, NCT03548558 
Date: January 8, 2020 
 
Research Collaborators 
 
Principle Investigator:                       Jill E. Luoto, PhD 
 
 
 
 
 
Economist, Professor  
 
 
 
 
 
Research and Development (RAND) Corporation, USA 
 
 
 
 
 
1776 Main Street, PO Box 2138 
 
 
 
 
 
Santa Monica, CA, USA 90407-2138 
 
 
 
 
 
+1.310.393.0411 x6337, jluoto@rand.org 
 
 
 
 
 
 
Co-investigators: 
 
 
Italo Lopez Garcia, PhD 
 
 
 
 
 
Associate Economist 
 
 
 
 
 
RAND Corporation, USA 
 
Daisy R. Singla, PhD, C. Psych 
 
 
 
 
 
Clinical Scientist  
Department of Psychiatry  
 
 
 
 
 
Mount Sinai Hospital, Canada 
 
 
 
 
 
 
Frances Aboud, PhD 
 
 
 
 
 
Professor Emerita 
 
 
 
 
 
Department of Psychology 
 
 
 
 
 
McGill University, Canada 
 
 
 
 
 
 
Lia Fernald, PhD 
 
 
 
 
 
Director, Public Health Nutrition 
 
 
 
 
 
Professor, Community Health Sciences 
 
 
 
 
 
University of California, Berkeley, USA 
 
 
 
 
 
 
 
 
 
 
Alie Eleveld, MPH 
 
 
 
 
 
Technical Advisor, Founding Member 
 
 
 
 
 
Safe Water and AIDS Project (SWAP) 

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Kisumu, Kenya 
 
Sponsor: United States of America National Institute of Health (NIH), Eunice Kennedy Shriver 
National Institute of Child Health & Human Development (NICHD), P.O. Box 3006, Rockville, 
MD 20847, USA. 
 
Abstract 
Recent neurobiological and psychological research has established that vital development occurs 
in language, cognitive, motor and socio-emotional development during the first few years of life, 
and early life outcomes are key determinants of adult outcomes such as educational achievement, 
labor market outcomes, and health. Yet more than 200 million children under age five in low and 
middle income countries (LMICs) will fail to reach their developmental potential as adults, 
predominantly due to poverty, poor health and nutrition, and inadequate cognitive and 
psychosocial stimulation. Early childhood development (ECD) interventions that integrate 
nutrition and child stimulation activities have been proposed as a powerful policy tool for the 
remediation of early disadvantages in poor settings, and numerous field studies have shown they 
can be effective in improving children’s developmental and health outcomes, at least in the 
short-term. Key questions remain on what models of delivery are the most effective and cost-
effective that can be potentially scalable in LMICs, as well as how to sustain parental behavioral 
changes over time, which can lead to long-term improvements in child development and the 
possibility of positive spillovers to benefit younger siblings. Having a better understanding of the 
underlying behavioral pathways leading from intervention, to parental behavior changes, to child 
impacts, is also key to inform policy about the optimal design of interventions to maximize their 
scalability and sustainability. Our study will conduct a multi-arm clustered randomized 
controlled trial across 60 villages and 1200 households in rural Western Kenya that tests 
different potentially cost-effective delivery models for an ECD intervention with a curriculum 
that integrates child psychosocial stimulation and nutrition education. Selected households will 
undergo baseline and follow-up surveys to measure short-term impacts in parental behaviors and 
children’s developmental outcomes, and we will collect data on potential mediators of parental 
behavioral change to uncover the pathways leading to impacts. Two follow-up surveys, one 
immediately after the end of the planned intervention and a second two years later, will enable 
testing of the short term and midterm sustainability of impacts, as well as the presence of any 
spillovers onto younger siblings. In collaboration with a local NGO, the Safe Water and AIDS 
Project (SWAP), community health volunteers (CHVs) will be trained to implement the 
intervention by introducing the ECD curriculum in their villages. 
The goal of this study is to provide policymakers with rigorous evidence of how best to expand 
ECD interventions in low-resource rural settings.  
 

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Contents 
Research Collaborators ................................................................................................................... 1 
Abstract ........................................................................................................................................... 2 
1. 
Background and Significance ................................................................................................. 6 
2. 
Rationale and Research Aims ................................................................................................. 7 
2.1 Research Hypotheses ............................................................................................................ 8 
2.2 Study Aims............................................................................................................................ 9 
3. 
Population ............................................................................................................................... 9 
3.1 Study Population ................................................................................................................... 9 
3.2 Inclusion Criteria .................................................................................................................. 9 
3.3 Exclusion Criteria ............................................................................................................... 10 
4. 
Study Design ......................................................................................................................... 10 
4.1 Design Overview ................................................................................................................ 10 
4.2 Sampling ............................................................................................................................. 10 
4.3 Study Timeline .................................................................................................................... 12 
5. 
Procedures ............................................................................................................................. 12 
5.1 Formative Research ............................................................................................................ 12 
5.2 Baseline surveys.................................................................................................................. 13 
5.3 Randomization .................................................................................................................... 14 
5.4 ECD Intervention ................................................................................................................ 15 
5.5 Follow-Up Surveys ............................................................................................................. 17 
5.6 Process Evaluation .............................................................................................................. 17 
6. 
Surveys and Measures........................................................................................................... 18 
6.1 Primary Outcomes of Interest and Associated Measures ................................................... 18 
6.2 Secondary Outcomes of Interest and Associated Measures ............................................... 19 

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6.3 Other Standard Measures .................................................................................................... 20 
6.3.4. Additional measures........................................................................................................ 21 
7. 
Data Analysis ........................................................................................................................ 21 
7.1 Aim 1: Adapt ECD curriculum ........................................................................................... 21 
7.2 Aim 2: Test effective means of delivery ............................................................................. 21 
7.3 Aim 3: Decomposition analysis .......................................................................................... 23 
7.4 Aim 4: Spillovers ................................................................................................................ 24 
7.5 Aim 5: Cost effectiveness and Process Evaluation ............................................................. 24 
8. 
Ethical Considerations .......................................................................................................... 25 
8.1 Human Subjects Involvement ............................................................................................. 25 
8.2 Targeted Enrollment ........................................................................................................... 27 
8.3 Rationale for exclusion ....................................................................................................... 28 
8.4 Sources of Data ................................................................................................................... 29 
8.5 Potential Risks .................................................................................................................... 29 
8.6 Recruitment and Informed Consent .................................................................................... 30 
8.7 Protection Against Risk ...................................................................................................... 30 
8.8 Data and Safety Monitoring Plan ........................................................................................ 31 
8.9 Potential Benefits ................................................................................................................ 33 
9. 
Implications of Research....................................................................................................... 34 
10. Challenges and Limitations..................................................................................................... 34 
11. 
References .......................................................................................................................... 36 
12. 
List of attachments ............................................................................................................. 40 
12.1 
Roles and responsibilities ........................................................................................... 40 
12.2 
Budget .......................................................................... Error! Bookmark not defined. 
12.3 Budget justification ............................................................ Error! Bookmark not defined. 

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12.4 Researcher CVs .................................................................. Error! Bookmark not defined. 
12.5 Ethics committee approvals from other institutions .......... Error! Bookmark not defined. 
12.6 Consent forms .................................................................... Error! Bookmark not defined. 
12.7 Data collection tools .......................................................... Error! Bookmark not defined. 
12.8 Curriculum excerpt ............................................................ Error! Bookmark not defined. 
 

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1. Background and Significance 
Recent neurobiological and psychological research has established that vital development occurs 
in language, cognitive, motor and socio-emotional development during the first few years of life1, 
and early life outcomes are key determinants of adult outcomes such as education achievement, 
labor market outcomes, and health. Yet, despite this, more than 200 million children under age 
five in low and middle income countries (LMICs) will fail to reach their full developmental 
potential as adults, predominantly due to poverty, poor health and nutrition, and inadequate 
cognitive and psychosocial stimulation.2–4 A growing body of evidence shows that Early 
Childhood Development (ECD) interventions that integrate nutrition activities and parent-child 
psychosocial stimulation can effectively improve developmental and health outcomes;5–7 
furthermore, integrated interventions that address the co-occurring risk factors associated with 
poverty can deliver the largest effects.1,2,7 Early childhood is also the most cost-effective period to 
improve such outcomes, as early investments have the potential to improve adult human capital.8,9  
 
The two primary methods for delivering ECD interventions are individual home visits with 
mothers, or group-based meetings in a primary care or community setting. Individual home visits 
can offer personalized feedback and attention, but are expensive to implement at scale.10,11 
Group-based models enjoy potential economies of scale, and can offer mothers increased peer 
support, which our team has shown to be a key mediator to maternal behaviors and psychological 
well-being in LMIC settings.12,13 However, groups may be comparatively weak in providing 
opportunities to practice and overcome personal barriers to behavior change, elements which are 
necessary to attain sustained parental behavior change and improved child development 
outcomes long-term.7 A recent review argues that group-based models which include a limited 
number of home visits are the most promising means to achieve sustained impacts and remain 
cost-effective,10 but the added impact and cost-effectiveness of such an approach is unknown. 
Moreover, few studies examine the behavioral pathways leading to intervention impacts,14,15 
which would foster their replicability. ECD interventions have also traditionally focused on 
mothers and children. Engaging fathers in their children’s development has been suggested to be 
beneficial,16,17 but has never been tested. Finally, there is no evidence of the sustainability of a 
group-based ECD intervention from a LMIC and whether these benefits spillover onto younger 
siblings. Key questions remain on what models of delivery are the most effective, parsimonious, 
and have the greatest potential for scalability in LMICs, as well as how to sustain parental 
behavioral changes over time, which can lead to long-term improvements in child development 
and the possibility of positive spillovers to benefit younger siblings. Having a better 
understanding of the underlying behavioral pathways leading from intervention, to parental 
behavior changes, to child impacts, is also pivotal to inform policy about the optimal design of 
interventions to maximize their scalability and sustainability.  
 
 

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2. Rationale and Research Aims 
The proposed research aims to experimentally test the effectiveness and cost-effectiveness of 
competing models of delivery of an Early Childhood Development (ECD) intervention in rural 
Kenya to determine how to maximize their reach to improve child cognitive, language and 
relevant psychosocial outcomes. The study will incorporate a longer-term evaluation of sustained 
impacts; an examination of the pathways of change leading to intervention impacts to inform 
policy; and examination of the role of paternal involvement on child development. Our study asks 
the following research questions:  
 
1) What is the most effective and scalable model of delivery for an integrated early childhood 
development intervention in a LMIC setting?  
2) Does father involvement matter for the adoption of better parenting practices at home and 
for child development?   
3) How can we design an early childhood stimulation intervention that is able to attain 
sustained impacts over time?  
4) What are the determinants of parental behavioral change towards better child-rearing 
practices? What role is played by parental beliefs, psychological wellbeing, knowledge, 
and social support? 
 
The designed ECD interventions have a curriculum that integrates child psychosocial stimulation 
and nutrition education.  The group sessions will be biweekly lasting seven months and will be 
aimed at improving developmental outcomes of children aged 6-24 months in rural areas of 
Kisumu and Vihiga counties, Kenya. These are among Kenya’s poorest regions, with rates of 
stunting ranging from 31-34%.18 
 
RAND Cooperation will work in collaboration with the Safe Water and AIDS Project (SWAP), a 
well-established and local Kenyan Non-Governmental Organization (NGO). SWAP has been 
operating in 6 counties in Western Kenya with public health programs, research and emergency 
response since 2005. SWAP has been contributing towards the Ministry of Health’s Community 
Health Strategy, whereby communities play an active role in their own health and development, 
SWAP is active member of the National Health NGO Network HENNET, and was elected as 
National Chair. HENNET stimulates linkages between the Ministry of Health, Private Sector and 
NGOs. During this study Community Health Volunteers (CHVs) will be trained to implement the 
intervention. The CHVs are local women recruited from Community Units and already trained on 
primary health care by the Ministry of Health and other development partners. They regularly 
conduct home visits and host community meetings on topics of community health in their 
respective villages. Our intervention integrates an experimental evaluation into this existing 
platform, a model of delivery that is potentially replicable in other similar contexts.  
 

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Figure 1 presents a conceptual framework for the pathways of change between the intervention 
and long-term changes in parental behaviors and child outcomes. The interventions presented in 
Figure 1 each feature one or more key mediators of behavior change in order to impact parental 
behaviors in the form of: i) more effective child psychosocial stimulation practices, ii) better 
nutrition practices; and iii) improvements in preventive health practices such as water treatment 
and hand washing. Changes in parental behaviors, in turn, can improve child outcomes 
including: a) child developmental outcomes that include cognition, expressive and receptive 
language development, motor skills and socio-emotional development; b) child health outcomes, 
captured by indicators of growth and anthropometrics; and c) potential spillovers of these 
impacts to children that are not targeted by the intervention (particularly to younger children at 
home). Our study’s primary outcomes of interest are both children’s development outcomes and 
associated parental behavioral changes, since the latter comprise the pathways of change leading 
to the former.  
 
 
2.1 Research Hypotheses 
Our primary hypotheses are: 1) village-based group meetings that include a limited number of 
follow-up home visits to reinforce the messages and give greater opportunity to practice the new 

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behaviours and receive personalized feedback is the most cost-effective model able to achieve 
sustained impacts in parental behaviours and child outcomes; and 2) Engaging fathers in the 
sessions will lead to greater impacts on children’s development and sustained parental behavioral 
changes 
 
 
2.2 Study Aims 
 Our study will be carried out with the following Aims:   
1. 
Adapt existing ECD curriculum to the local Kenyan context and evaluate its 
acceptance in a piloting phase. Incorporate strategies to involve fathers. 
 
2. 
Test the most effective means of delivery – whether only group visits, or group-visits 
with added home visits and booster sessions, and with or without fathers’ 
involvement - of an ECD intervention to improve child-rearing practices and child 
developmental outcomes using a clustered randomized control methodology. 
 
3. 
Disentangle the underlying mechanisms through which the intervention drives 
behavioral changes and child outcomes combining the experiment and collected 
measures in a Decomposition Analysis.14 
 
4. 
Examine the sustainability of any child impacts and associated parental behavioral 
changes as well as the presence of spillovers to younger siblings two years later. 
 
5. 
Perform a cost-effectiveness analysis and a process evaluation to inform policy. 
 
3. Population 
3.1 Study Population 
This study will take place in two counties, Kisumu and Vihiga, within the former Western and 
Nyanza Provinces, Kenya, an area characterized by high rates of poverty, child mortality, and 
stunting (31-34%), with the highest levels of reported spousal violence in Kenya (60%), and high 
levels of teenage motherhood (18%).18 
3.2 Inclusion Criteria 
• Kenyan mothers or equivalent female primary caretakers aged 15 and over with children aged 
6-24 months (classified as mature minors) 
• Kenyan fathers aged 18 and older with children aged 6-24 months with a mother present 

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The unit of observation for the study is the household or family, within which our primary focus 
is mother-child dyads and household eligibility hinges on the age of the child. For those 
households with a father present, we additionally include him in some analyses and surveys.  
3.3 Exclusion Criteria 
• Households without children 
• Households with children that are outside the age range of 6-24 months at baseline 
• Households with children aged 6-24 months who are found to have severe developmental 
delays.  
• Households with a mother younger than 15 or one aged 15-18 still living with her parents 
• Single fathers  
 
Selection criteria for fathers are based on the mother-child eligibility criteria. Fathers will be 
included if and when appropriate per the details surrounding the mother-child dyads. 
 
4. Study Design 
4.1 Design Overview 
Our evaluation design consists of a clustered Randomized Control Trial (cRCT) in which 60 
CHVs and their associated villages will be randomly assigned to one of three equally-sized 
treatment arms. Arms 1 and 2 comprise a 2x2 factorial design, while Arm 3 will serve as a 
control group.  Our experimental design features 3 treatments: group meetings only (Arm 1), 
group meetings with a limited number of individual home visits (Arm 2), and the involvement of 
fathers in the integrated intervention (one half of villages in Arms 1 and 2). All households, 
including the control group, will receive basic information about child feeding and a “hygiene 
pack” consisting of a bottle of WaterGuard (a chlorine water treatment product) and a bar of soap 
(total value 50 Ksh) during a baseline survey. Our study includes a control group in order to 
identify the effects of a parenting intervention and the most effective mode of delivery, as well as 
the sustained impacts from the intervention. Due to the nature of the ECD intervention, a 
comparison group is necessary to address our key research questions. Other analysis forms such 
as a before-after analysis do not work in the context of a child development intervention due to 
the rapid changes happening during the early years of life.  
4.2 Sampling 
The target population for the full study is comprised of 1200 households across 60 villages 
surrounding 3 Jamii (“community”) centers operated by SWAP in Ahero, Sondu, and Kegondi 
towns within Homa Bay and Vihiga counties. In addition, prior to the full evaluation, we will 
pilot the curriculum in a formative stage among a total of 6 villages with 20 households meeting 

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similar eligibility criteria in each village (120 households total), with pilot villages stratified 
across the Jamii centers. (More details about the pilot sampling in 5.1.1.)  
 
The sampling strategy of villages and households participating in the full study will follow three 
steps. In a first step, we will list all potential villages in the subcounties of East Racuonyo and 
South Rachuonyo in Homa Bay county, and in Sabatia subcounty in Vihiga county that satisfy 
three requirements: 1) There are estimated to be at least 20 households with children that will be 
between 6 and 24 months old at the time of the baseline survey (October 2018) for inclusion in our 
study based on CHV report; 2) There is at least one Community Health Volunteer assigned to that 
village by the local Community Health Unit (CHU) who can be trained into the study curriculum; 
and 3) Villages will be sufficiently geographically dispersed so that households within villages 
assigned to the control arm do not travel to access the intervention in treatment villages. 
Second, we will randomly select a representative sample of 60 villages to participate in the full 
study stratified by each Jamii center (20 villages per center). The villages will form our study’s 
clusters, from which we will sample households to participate in surveys and the village-based 
ECD sessions in Arms 1 and 2. CHVs associated to those villages will be made aware of the 
likely time commitment that may include attendance at the two-week training course as well as 
time to implement the interventions if assigned to Arms 1 or 2. We will pay all CHVs a stipend 
for their collaboration in the delivery of the study and the intervention. If CHVs refuse 
participation, we will resample from our pool of eligible villages for inclusion in the study.    
 
Third, within each selected village, CHVs will conduct a census of all households in their village 
to identify all those with a child aged 6-24 months at baseline. From this list of households, we 
will draw a sample of 20 households using a random number generator, with 5 more names on a 
ranked waitlist in cases of study refusal.  
 In short, the sample shall consist of: 
• For the piloting phase: 
o 6 villages with 20 households in each village, or 120 households total  
• For the full evaluation, a total of 60 villages 
o 20 in Arm 1 (groups only), 20 in Arm 2 (groups plus home visits), and 20 in Arm 
3 (Control group) 
o Among the 40 villages in Arms 1 and 2, 20 will have fathers invited; 20 without 
fathers invited and only mothers and children are invited 
• 20 households per village are invited to the sessions  
• Total sample of 1,200 households in the full evaluation  
• A total of 46 Community Health Volunteers will be trained, 6 in the pilot and 40 in the full 
study (20 CHVs and associated villages will comprise a control group). Pilot households 
and CHVs will not participate in the full evaluation. 
 

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4.3 Study Timeline 
We will begin the community entry and curriculum piloting activities upon IRB approval from 
all necessary review boards in roughly May-June 2018. 
The baseline survey will be undertaken in late September-October 2018. Training of the 40 
CHVs in villages assigned to an intervention arm will occur at the end of baseline activities. 
Immediately following, these 40 CHVs will implement the biweekly village sessions beginning 
in November 2018. The total 16 sessions will last from November through June 2019. A first 
follow-up impacts survey will be undertaken immediately following the end of the intervention 
period in July-August 2019. Following completion of the follow-up survey, we will randomly 
select 20 of the 40 intervention villages stratified by study arm and subcounty to receive 
bimonthly group booster sessions for approximately 1.5 years until we undertake a second and 
final follow-up impacts survey in May-June 2021.  
5. Procedures 
5.1 Formative Research 
5.1.1 Community Entry  
SWAP Management Members will seek approval and introduce the study to County Health 
Management Teams of Homa Bay and Vihiga followed by further orientation of the Sub County 
Health Management Teams of Sabatia (Vihiga), South Rachuonyo and East Rachuonyo 
(Homa Bay County) Courtesy calls will be made to the County Executive Committee members 
for Education and local administrative leaders prior to the start of the study. The approved 
protocol will be shared with the County Health Management Teams.  
5.1.2 Curriculum Pilot  
The curriculum will be piloted in six villages in order to adapt it for the rural western Kenya 
context. We will recruit six “mentor” CHVs who will be trained to deliver this intervention in the 
6 pilot villages, and following this pilot these 6 CHVs will assist in the training of the 40 CHVs 
for the full study as well as help with monitoring of the sessions among intervention villages in a 
supervisory role. 
 
Within each village selected for the pilot, 20 household participants will be recruited in a similar 
fashion as that for the full study described in 4.2, totalizing 120 households.  Eligible participants 
will be 15(+) years old and the parent of a young child (aged 6-24 months). Within each 
household, both the mother and the father will be recruited. These pilot households will be 
invited to participate in up to 4 sessions to be piloted in their communities from the 16 total 
sessions that will form our main study’s intervention curriculum.  
 

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5.1.3 Exit Interviews of Pilot Participants and CHVs 
All mothers and fathers that attend a pilot session will be invited to participate in exit interviews 
immediately following a given pilot session.  The exit interviews will probe key aspects related 
to curriculum content, acceptability and applicability. The exit interviews will inform the 
curriculum content and delivery mechanisms that will be implemented in the full intervention. 
The exit interviews have an open response structure, ensuring that we receive responses to well-
defined questions while allowing room for open response. The data gathered will be used to 
improve operational aspects of the village-based ECD sessions as well as to adapt existing ECD 
curriculum to the local context, including incorporating fathers in a culturally-appropriate way.   
 
At the end of the piloting phase, we will also perform exit interviews of the six pilot CHVs to 
understand their experiences delivering the program in order to finetune the training they 
underwent to improve it for the full study, as well as gather feedback on ways to improve the 
intervention and its associated activities.  
 
The exit interviews for both parents and CHVs will be delivered by local research assistants who 
will be trained in qualitative methods.   
 
5.1.4 Pilot Baseline Survey  
A total of 144 households from villages not sampled for inclusion into the full survey will be 
selected to participate in the piloting of the baseline survey. The objective of the survey pilot is 
to ensure that each of our measures have the proper translation and understanding, as well as to 
test the application time and logistics.  The protocol and research tools that will be used are 
presented with the baseline survey procedure in section 5.2. 
5.2 Baseline surveys  
Following the pilot for the full study sample, from the list of 20 names assembled by the CHV 
from the village census, the CHV will guide a trained interviewer to the households to invite them 
into the study and to undergo informed consent procedures for participation. All households, 
irrespective of their village’s eventual group assignment, will receive written and verbal consent 
explaining the purpose and contents of the study as well as their anticipated time commitment for 
attending the village-based sessions and any home visits. We will also make clear that participation 
in the surveys is voluntary and participation in the ECD intervention is not guaranteed but based 
on their village’s random assignment in a language understandable to the participants.  
After consent, the interviewer will assess the child and interview the mother and, for married 
mothers, also the father for a subset of modules. Participants who provide informed consent will 
be asked to participate in this survey before the village randomization takes place to make sure 
that the group assignment does not influence the answers given. The measures will include 

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household socio-economic data, maternal self-report on child developmental outcomes, child-
rearing practices, attitudes and beliefs towards child-rearing, and maternal psychological well-
being, and paternal self-report about their involvement in child-rearing tasks. One-week training 
sessions will be conducted before the beginning of the fieldwork. In total, the survey will last 
between 60 to 90 minutes and will collect information on variables described below in the Survey 
Measures section. In addition, the baseline survey will record mobile phones and other sources of 
contacts for each of the household members. This will be done to facilitate invitations to ECD 
sessions (if assigned to a treatment arm) as well as to ensure successful tracking for follow-up 
surveys. Finally, at the end of the baseline survey all households will receive information about 
proper nutrition for young children as well as a hygiene pack consisting of a bottle of WaterGuard 
and a bar of soap as a token of appreciation for their time (valued at 50 Ksh).  
 
5.3 Randomization 
After the sampling procedure and the baseline surveys are complete, we will randomly assign the 
60 CHVs and their associated villages to one of three study arms. Each arm will have 20 CHVs 
and 400 households (Figure 2). After assignment to study arm, villages assigned to Arms 1 or 2 
will undergo a secondary randomization procedure to determine those villages that additionally 
will invite fathers to the sessions (in a 1:1 ratio among the 40 villages assigned to Arms 1 and 2). 
All randomizations will be stratified by Jamii center to ensure balance across treatment arms on 
any village-level characteristics that have the potential to have some relationship with 
intervention effects. CHVs assigned to Arms 1 and 2 will undergo the CHV Training in order to 
deliver the ECD intervention. 
5.3.1 Arm 1 (“group” sessions) 
Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 
sessions over 7 months. CHVs will record attendance at each session. To maximize participation, 
prior to each session the CHVs will send an SMS reminder of the session’s topic, time and 
location to all participants. All attendees at a session who arrive within a half hour of the 
intended start time will receive a small bar of soap as a token of appreciation for their timely 
attendance.  
5.3.2 Arm 2 (“group+home” sessions) 
Households in Arm 2 will receive a total of 16 sessions with identical content similar to Arm 1, 
but 4 of those sessions will replace group sessions held at the level of villages for personalized 
home visits, in which the CHV will visit each participant household to deliver these sessions. 
These home visits will cover identical material and topics as the group sessions in Arm 1 
villages, but will be delivered on a personalized basis in the home of the mother and child. 
Personal barriers to the practices will be discussed and an active resolution strategy developed in 
concert with the CHV.  

15 
 
5.3.3 Father Involvement (“fathers”) 
 In villages assigned to receive the father-focused sessions, fathers will be invited to attend the 
sessions along with the mothers. For some of the 16 sessions, they will be invited to attend 
separate sessions from the mothers. 
5.3.4 Control group 
Households in villages assigned to Arm 3 will receive the usual services of their CHV, which 
includes basic services for community health. In addition, control group households will receive 
the same information about child feeding and the hygiene packs as households in villages 
assigned to intervention arms during the baseline survey. 
 
5.3.5 Booster sessions  
Following the end of the 16 biweekly sessions, we will randomly select 20 of the 40 intervention 
villages stratified by study arm and subcounty to receive bimonthly group booster sessions for 
approximately 1.5 years from the end of the endline survey until we undertake a second and final 
follow-up impacts survey in August-September 2021.  
5.4 ECD Intervention 
 
Our integrated child psychosocial stimulation and nutrition education intervention will build on 
our team’s combined previous work delivering and evaluating group-based ECD interventions in 
Uganda, Bangladesh, Madagascar, Mexico, and Chile. Most of these were implemented over a 
period of six months, and all were found to significantly improve child and maternal outcomes. 
The final curriculum will be informed by insights for achieving sustained behavior changes and 
will include session-specific lessons and materials.  
Forty CHVs assigned to Arms 1 and 2 will undergo an intensive training course covering topics 
that will be addressed in each of the group sessions in order to prepare CHVs with the 
knowledge and ability to deliver the intervention to participant households in their villages. 
Luoto, Lopez Garcia, Aboud and Singla will deliver the trainings and have many collective years 
of experience delivering similar trainings in various LMIC settings. Competency assessments of 
the CHVs will be undertaken at the end to ensure the implementers are of high quality. This 
training will occur after randomization of villages, described below.  
Following training, these 40 CHVs will implement the village-based ECD sessions for seven 
months in their villages. Mother-child dyads from the 20 households that gave consent and 
underwent baseline surveys in each village assigned to Arms 1 or 2 will be invited to attend the 
sessions, which will be located at a suitable central locale such as a school, church, or village 
chief’s homestead. 
 

16 
 
5.4.1 ECD Group-based Curriculum  
The curriculum for the group-meetings will be finalized in our pilot stage. A total of 16 sessions 
will be held biweekly in selected villages and lasting 60-90 minutes per session. The curriculum 
will be specific to each session, with sessions devoted to mother-child interactions covering 
topics such as play and language, cognitive simulation, socio-emotional stimulation, 
management of child behavior, and child health care practices including diet and hygiene, and 
sessions devoted to improving maternal self-image, self-efficacy and self-esteem. Active and 
interactive activities will be designed drawn from evidence-based cognitive, behavioral, 
interpersonal and stimulation interventions, including role-playing, group-based problem 
solving, and parent-child interactions, and will allow time for feedback, all of which are 
important mediators of behavior change (Figure 1). In half of villages, fathers will be invited to 
sessions and participate in group activities. Because of the high levels of domestic violence and 
young motherhood in the region, some sessions will also spend time devoted to address family 
barriers that limit the development of a nurturing home environment, and focus on the roles of 
love and respect and a positive home environment to improve overall family functioning. Aboud 
and Singla’s experience in Uganda, as well as Luoto’s and SWAP’s experience in the study area, 
will serve as examples for how to broach sensitive topics. In all sessions, participants will hear 
about the benefits of the behavior and be encouraged to practice in the presence of the CHV and 
their peers through games and activities; following this practice, participants will discuss in a 
group setting any experienced barriers as well as strategies to overcome barriers in their homes. 
Participants will be encouraged to practice the new behaviors between sessions.  
5.4.2 Individual home visits  
Households in Arm 2 (group+home) will receive four total home visits that replace four group 
sessions. During these home visits, CHVs will review the key messages learnt in the group 
sessions; give mothers the opportunity to practice the strategies and receive individual feedback; 
and the CHVs and parents will work together to overcome family-specific barriers to adopting 
and sustaining the new strategies in a more personalized way. Figure 1 outlines how home visits 
reinforce these key mediators of parental behavior change.   
5.4.3 Father Engagement Curriculum  
A total of 5 of the 16 sessions is envisioned to aim to add greater social support and problem-
solving abilities for whole families (Figure 1). The curriculum for these sessions will cover 
interpersonal topics relevant for behavior change at the family-level such as father involvement 
in child care, emotional regulation, and the types of emotional support that fathers could provide 
to their spouses that would be beneficial for their children’s health and development. The same 
topics will be covered in all villages, but in half of villages fathers will participate in these 
discussions and activities. We will design group activities that indirectly show the benefits of a 
home environment free of domestic violence and which focus on love and respect.  

17 
 
5.4.4 Booster sessions   
The extended bimonthly booster sessions over a 1.5 year span can achieve multiple aims for the 
families in villages selected to receive them. First, CHVs will continue to offer these families 
personalized social support, remind mothers and fathers of the key messages, and incorporate 
strategies to help parents adhere to the behaviors already learned. Second, CHVs will 
demonstrate new stimulation and communication activities that meet children’s growing 
intellectual needs as they age, and which scaffold on practices they have already learned. And 
third, they will also introduce and discuss new topics relevant for older children including more 
advanced language development techniques such as “dialogic reading” using picture books, and 
more appropriate disciplinary strategies and behavioral regulation to manage children’s 
adaptive behaviors.  
5.5 Follow-Up Surveys 
At the end of the seven-month village-based ECD sessions, and again during year 4, follow-up 
surveys will be conducted on households surveyed at baseline in all 60 villages. These follow-up 
surveys will enable evaluation of the intervention’s short-term and medium-term effects on 
children’s cognitive, psychosocial and health outcomes, as well as maternal mental wellbeing 
and mother-father interactions. The set of measurements for developmental outcomes is 
described in the Measures section.  
5.6 Process Evaluation 
5.6.1 ECD Session Attendance Records  
During implementation, the 40 CHVs in Arms 1 and 2 will collect attendance records at each 
ECD session. They will also be asked to keep monitoring checklists of their activities following 
each biweekly session. These monitoring and attendance forms will be collected using encrypted 
data collection forms on SurveyCTO via tablets and uploaded to the study’s server as detailed in 
the data safety and monitoring plan.  
5.6.2 Observation of ECD group sessions 
SWAP’s Project Officers who manage the Jamii centers and oversee regular CHV operations 
will be trained to observe and monitor essential components of a selection of sessions hosted by 
the CHVs during the implementation in Arms 1 and 2, with assistance from the 6 mentor CHVs 
who undertook the pilot. They will use a monitoring form to report on activities and fidelity of 
the delivery to the intended design.  
5.6.3 Reports made by CHVs on Home visits 
In Arm 2, a subset of CHV who deliver home visits will be asked to make a series of 
observations on the extent to which mothers (and fathers if applicable) are practicing the ECD 
activities that were taught during the group ECD sessions held in their villages.  This information 

18 
 
can be used to make improvements to the implementation of remaining sessions and to ascertain 
how much mothers report practicing the behaviors and experienced barriers and facilitators.  
5.6.4 CHV Focus Groups 
Midway through the implementation of sessions we will conduct interviews and focus groups 
with those CHVs assigned to the two treatment arms, and those who led ECD interventions in 
villages where fathers were included in order to learn what works and what does not from CHVs’ 
perspective, and use the collected monitoring measures to undertake the Process Evaluation. The 
focus groups will follow a discussion guide with open ended questions and probes, ensuring that 
we receive responses to well-defined questions while allowing room for open discussion. It will 
be delivered by local research assistants who will be trained in qualitative methods.   
 
6. Surveys and Measures 
The survey measures chosen for the assessment module and how they relate to our primary and 
secondary outcomes of interest are described below. Each measure is guided by our conceptual 
framework (Figure 1) and have been successfully used in our previous research and ensure a 
reasonable interview duration. Piloting will further ensure we avoid respondent burden to keep 
the survey at reasonable length. All measures will be included in the assessment battery 
administered at each time point. We will measure child assessments using the Bayley III scale at 
the baseline and follow-up surveys. For those children who have aged out of the acceptable age 
range for the Bayley III by the second follow-up survey (up to 42 months), we will use the 
MDAT scale. All materials have been translated into Luo and Swahili using standard translation 
and back-translation methods. Our primary outcomes of interest are child developmental 
outcomes, as well as child psychosocial stimulation. Secondary outcomes are child growth and 
anthropometrics (which are usually more difficult to impact without food supplementation), child 
nutrition practices, preventive health behaviours, and the presence of spillover impacts onto 
younger children. We will also collect measures that relate to one or more mediators of 
behavioural change from our conceptual framework. Finally, socio-economic data for all 
households will include family composition, employment, wealth, and housing conditions.  
6.1 Primary Outcomes of Interest and Associated Measures 
6.1.1 Child cognition, language, motor skills, socio-emotional state 
The Bayley Scales of Infant Development 3rd edition (Bayley’s III),19 is validated in African 
settings and provides measures for all dimensions of child cognitive, receptive and expressive 
language development up to 42 months of age. In the second follow-up survey for children in 
2021, we will use the Wechsler Preschool and Primary Scale of Intelligence (WPPSI) Block 
Design test20 and adapted forms of the British Picture Vocabulary Scale – III (BPVS III) 
receptive and expressive language tests21 which have been previously adapted to the local 

19 
 
setting including in Swahili and Luo languages.22 We will use the Wolke behavioral rating 
scale (Wolke et al., 1990)23 to obtain observational measures of child socio-emotional 
development and emotional regulation. The test will be administered immediately after the 
child finishes the Bayley test to capture how unhappy, happy, fussy or cheerful the child 
appeared throughout the administration.  At the 2021 follow-up, we will use the Strengths 
and Difficulties Questionnaire in place of the Wolke Scale for our children who are now 
older.24  
6.1.2 Parental behaviors 
At baseline we will use the Family Care Indicators 25, a self-reported scale of parenting practices 
which measures the quality time spent with children in learning and playing activities for young 
children at home. Examples of questions are how often parents take children out to the park, or 
other recreational activities, whether there is always an adult looking after children, the 
frequency of learning and play activities with children, and the amount and variety of play and 
learning materials. Five subscales can be created for analysis: ‘play activities’ (PA), ‘varieties of 
play materials’ (VP), ‘sources of play materials’, ‘household books’, and ‘magazines and 
newspapers’ (MN). 
In the first follow-up survey we will complement the Family Care Indicators with observational 
measures of practices using the Home Observation for Measurement of the Environment 
(HOME) inventory, a 45 item structured survey combining mother self-report and observational 
measures, which has been used and validated to measure cognitive and non-cognitive stimulation 
strategies in both developed and developing countries. 26 Versions of the HOME inventory have 
already been adapted to African settings for children up to 4 years old. For the second follow-up, 
we will adapt a version of the Home Observation Measurement of the Environment-Short Form 
(HOME-SF) for parents of children of 3 to 6 years old.  
6.2 Secondary Outcomes of Interest and Associated Measures 
6.2.1 Child anthropometrics 
Child weight and height, and arm circumference will be measured using techniques for the WHO 
Multicenter Growth Reference Study (MGRS). 27  
6.2.2 Nutrition and preventive health practices 
Dietary diversity will be measured by maternal self-report of the foods eaten by the children in 
the last 24 hours, following WHO recommendation about youth and infant child feeding. 28,29  
Food security will be measured using the Household Hunger Scale derived from the HFIAS.30 
These measures will be used to assess secondary outcomes of interest including child 
anthropometrics, nutrition practices, and preventative health. 
 

20 
 
6.3 Other Standard Measures 
6.3.1 Perceived social support 
We will measure perceived social support using the 6-item Lubben Social Network Scale 
(LSNS)31, and perceived support from spouses will be measured using the Relationship Support 
Scale that asks questions about positive and negative behaviors of husbands with wives and 
children.12 (Singla et al. 2015a). We will also ask mothers about the networks to which they 
belong and ask if they discuss any health, nutrition and parenting tips with other 
households in their village.32  These questions will include naming up to 5 individuals  with 
whom respondents have regular contacts. To meet regular standards of confidentiality,  
enumerators will only save the initials of these individuas and therefore the data saved will 
be de-identified.    
 
6.3.2 Problem solving and social support 
We will adopt measures from our work in Uganda to measure ways of coping with interpersonal 
conflicts and daily stressors.33  Parental stress will be assessed using the Daily Stress Index 34. 
The DSI measures on a 0-2 scale (never, sometimes, often) the difficult things that sometimes 
happen to people. This index has previously been used in Uganda, and the raw score will be 
aggregated over the 15 parts with a range of 0-30.34 We will measure maternal psychological 
well-being using the widely used Center for Epidemiologic Studies Depression Scale (CESD) 
with proven psychometric properties. 35  
 
6.3.3. Maternal Knowledge 
We will elicit maternal knowledge about child development through asking mothers about the 
ages at which they think the child would be able achieve certain developmental milestones, 
which are then compared with the expected ages reported in the literature. We will also assess 
maternal receptive vocabulary. The Peabody Picture Vocabulary Test is among the most 
widely used receptive vocabulary tests in the world. The PPVT-4 (4th Edition), which was 
released in 2007, and was standardized through administration to more than 5,000 
respondents in 2005 and 2006.36 Form A consists of 228 test words for a respondent to 
identify among four color pictures as potential responses for each of the words. For each 
word, the respondent is instructed to point to the picture on the page that best represents 
the word’s meaning.  
6.3.4 Maternal Beliefs 
We will adapt and measure the scale to elicit beliefs developed by Cunha et al. (2013)37 with the 
target of eliciting parental beliefs regarding the benefits of providing children better cognitive 
and non-cognitive stimulation. The instrument asks parents about developmental milestones in 
language and socio-emotional development under different home scenarios, which are 
constructed using data from the Family Care Indicators. We will also we adopt a subscale of 
the Parental Cognitions and Conduct Toward the Infant Scale (PACOTIS) (Boivin et al. 

21 
 
2005),38 a 5-item Likert scale to assess the perceived parental impact of their behavior on 
the developing child. We will measure parental self-perceived competence in parenting 
using the Self-Efficacy for Parenting Tasks Indexes- Toddler Scale (SEPTI-TS) (Van Rijen 
et al. 2014),39 which is aimed at measuring parental self-efficacy for parents of toddlers 
aged between 13-36 months.  
 
6.3.4. Additional measures 
Additional survey modules will collect information on household demographics, socioeconomic 
status, household-level shocks and life stressors,40 time use, time preferences, and questions 
regarding fatherhood will be drawn from previous studies conducted in SSA context and adapted 
for use in Kenya.  
 
In addition, the baseline survey will record mobile phones and other sources of contacts for each 
of the household members and close relatives. This will be done to facilitate invitations to ECD 
sessions (if assigned to a treatment arm) as well as to ensure successful tracking for follow-up 
surveys. 
 
In 2021, we will drop modules on household-level shocks and life-stressors, time use and 
time preferences, all questions for fathers, and questions about social networks of mothers. 
We will add questions about prices for commonly purchased items in villages and other 
village characteristics, questions about a mother’s views on how COVID has affected her 
household, questions about a mother’s reproductive history, views and experiences with 
intrahousehold conflict, and childhood experiences. All new survey modules for mothers 
are highlighted in pink in the attached document.  
7. Data Analysis 
7.1 Aim 1: Adapt ECD curriculum 
The formative research will form core components of this adaptation to ensure acceptability. The 
process evaluation will include measures of session attendance, mother interviews, and exit focus 
groups of CHVs, all of which can also inform the intervention’s acceptability.  
7.2 Aim 2: Test effective means of delivery 
The aim is to get fully powered estimates of intervention effectiveness on child outcomes, 
parental behaviors, and mediators across the different arms of the study.   
7.2.1 Power Calculations 
 

22 
 
The sample of 60 villages and 20 households per village for the full evaluation is calculated for 
measures of child developmental outcomes that will be measured using the Bayley III scale taken 
at the first follow-up survey. This scale has a usual mean of 100 with a standard deviation (SD) 
of 15.19 Meta-analyses calculate a mean effect size from group ECD interventions of 0.59 SD7 
and our previous work in Uganda has an effect size of 0.36 SD.12 Our previous work in this part 
of Kenya has found annual attrition rates of roughly 15% and we enjoyed roughly 80% 
compliance in a previous collaboration in the study area on a similar population of mothers with 
young children.41 Similar group ECD interventions in Uganda and Bangladesh have found intra-
cluster correlation coefficients (ICC) of 0.04.42 We conservatively assume 75% compliance 
among those invited to the sessions, 15% attrition, and an ICC of 0.07 within 60 CHV catchment 
areas. In a side-by-side comparison between study arms our sample size of 400 mother-child 
dyads in each arm provides 80% power to detect an increase in children’s cognitive and 
receptive language development of 0.30 SD at the 5% level of statistical significance. The impact 
from involving fathers has similar power. In a 2:1 test comparing the two treatment arms and the 
control arm we can detect a 0.26 SD effect size under similar assumptions. To detect spillovers 
effects in younger siblings at the second follow-up impacts survey we estimate that roughly 75% 
of households will have a younger sibling (average parity is about 5.4 children per mother in 
Nyanza18), implying we can detect 0.33 SD effects in comparing siblings of treated vs. untreated 
children at the second follow-up survey.   
7.2.2 Empirical strategy 
We plan to estimate two treatment parameters: Intention-to-Treat (ITT) and Average Treatment 
on the Treated (ATT), using the randomization as an instrumental variable. Let 𝑌 denote an 
outcome of interest at a follow-up survey (child outcomes, parental behaviors or mediators), and 
D is a dummy variable for the random allocation to treatment arms. ITT is captured by: 
 
𝑌 = 𝛼0 + 𝛼𝐼𝑇𝑇𝐷+ 𝑋′𝛽+ 𝜀       (1) 
In equation (1), 𝛼𝐼𝑇𝑇 is the ITT parameter, 𝑋 are other covariates, and 𝜀 is an error term. The 
basic identifying assumption is the mean independence of the error term with respect to 
treatment status. In our intervention, it is perhaps more interesting to estimate ATT treatment 
effects among those who participated if there is imperfect compliance. These effects are captured 
in the following system of equations:  
𝑌 = 𝛼0 + 𝛼𝐴𝑇𝑇𝑃+ 𝑋′𝛽+ 𝜀       (2) 
P = 𝑏0 + 𝑏1𝐷+ 𝑋′𝛾+ 𝜂   (3) 
Here, equation (2) is the outcome equation where 𝑃 is a dummy variable for observed 
participation, which can differ from the random allocation if there is imperfect compliance. 
Equation (3) corrects for selection bias into participation by modelling the participation decision 
using the randomization as an instrumental variable, and estimating by 2SLS methods. With this 

23 
 
framework, ITT estimates of the relative gains of the added home visits in Arm 2 against the 
group visits of Arm 1 and the control group in Arm 3 are captured by the simple mean 
differences in outcomes at follow-up between groups. To estimate the ATT, we instrument 
participation with dummy variables for the random assignment to Arms 1, 2 or 3.  
7.2.3 Handling missing data and attrition 
We will fit logistic regression models to assess whether this dropout is random and we will 
construct “nonresponse” weights to correct for non-random dropout in all our regressions and in 
the calculation of standard errors and tests of significance. 
7.3 Aim 3: Decomposition analysis 
Aim 3 is to uncover how different types of parental behaviors influence child outcomes, and how 
different mediators influence those parental behaviors. This information is perhaps more 
important than identifying treatment effects separately for different outcomes, as it allows us to 
understand why the intervention works, and in a prospective approach, such an analysis can 
inform policy on how to improve ECD interventions. We use Decomposition Analysis15 to 
identify three different pathways via which we hypothesize our interventions affect child 
outcomes (Figure 1):  
Pathway 1: Through changes in one or more mediators, the intervention changes parental 
behaviors. For example, mothers learn new strategies and drop old practices that did not benefit 
their children. This pathway is of key importance to understand how our interventions can 
achieve sustained changes in parental behaviors.  
Pathway 2: Through changes in mediators, the intervention changes the productivity of parent 
behaviors, making them more efficient and thereby improving child outcomes. For example, 
mothers do not change their actions, but they perform those actions more efficiently.   
Pathway 3: Through changes in mediators, the intervention changes some unobserved mediators 
and behaviors not captured in our survey measures. Denoting mediators by (𝑌𝑀), parental 
behaviors by (𝑌𝐵), and child outcomes by (𝑌𝐶), equations (4) and (5) capture these pathways in 
the following statistical model: 
 
𝑌𝐵 = 𝛽0 + 𝛽1𝑌𝑀+ 𝛽2𝑋+ 𝜀𝐵  (4) 
𝑌𝐶 = 𝛼0 + 𝛼1𝑌𝐵+ 𝛼2𝑋+ 𝜀𝐶  (5) 
         
 
 
Equation (4) describes Pathway 1. It means that the intervention, through changes in different 
mediators, could change different parental behaviors at follow-up. To identify the set of 
parameters of interest, 𝛽1,we need to measure all the relevant mediators for parental behaviors 
P1 
P2 
P3 

24 
 
that are likely to change with our interventions so there are no unmeasured mediators that 
correlate with the error term. We address potential concerns about this assumption by collecting 
very rich data on different mediators (Table 1), and by including parental behaviors at baseline in 
the vector 𝑋 to control for time-invariant unobserved mediators.    
Equation (5) summarizes the interaction of the three pathways of change in a production function 
of child outcomes.43–47 The intervention, through changes in mediators, can change behaviors 
(Pathway 1 - Equation 4), or can change the productivity of those behaviors (Pathway 2). This 
parameter,𝛼1, is extremely important for the validation of our model of change in Figure 1 
because it will inform how different behaviors affect child outcomes. For example, reading to the 
child might be important for child language and cognition, but not as important for socio-
emotional development or health. Finally, the parameter 𝛼0 will capture changes from the 
intervention on unmeasured inputs in the production of child outcomes (Pathway 3).  
The estimation of equation (5) is a very difficult task if: i) measured and unmeasured inputs are 
correlated, and ii) unobserved inputs can change with the intervention.15 To achieve 
identification, we need to minimize the number of unobserved behaviors that vary with 
treatment. We will collect a very rich set of variables both at baseline and at follow-ups to reduce 
the number of potentially unobservable behaviors and inputs that may change with treatment. 
Also, by incorporating baseline measures in the production function, we will control for 
unobservable inputs that are time-invariant. To account for potential measurement error in 
variables, we will use a latent factor model from our set of measurements, following standard 
methodologies used in the literature to identify and estimate all the relevant latent constructs.45,48   
7.4 Aim 4: Spillovers  
Assessing spillover impacts of the intervention onto younger siblings is straightforward and 
draws from the same analysis plan as in Aim 2. Instead of using the outcomes for age-eligible 
children in equations (1) and (2), we use outcomes measured at the second follow-up survey for 
younger children in the household.  
7.5 Aim 5: Cost effectiveness and Process Evaluation 
 We will assess the relative cost-effectiveness of each study arm using standard methodologies 
described by Gold and colleagues.49 Cost-effectiveness analysis (CEA) is a method of comparing 
the economic desirability of alternative health interventions by calculating the marginal cost of a 
unit of improved health.49 Our measure of cost-effectiveness will be the incremental cost-
effectiveness ratio (CER), defined by the difference in the per-capita cost of the treatments 
divided by the difference in the average effectiveness of the interventions. Costs in the analysis 
will be assessed using a societal perspective, taking into account all treatment costs (e.g. CHV 
payments, cost of materials) as well as costs that accrue to the participant (e.g. transportation 
costs). Specifically: 

25 
 
𝑪𝑬𝑹=
μ𝑐2−μ𝑐1
δ𝑒2−δ𝑒1    (6)  
where μ𝑐2 is the per-capita cost of the group + home treatment in Arm 2, μ𝑐1 is the per-capita 
cost of group visits alone in Arm 1, δ𝑒2 is a measure of compliance with treatment such as share 
of attendance to the sessions, and δ𝑒1 is the same measure for participants in Arm 1. We will 
perform a similar analysis comparing Arms 1 and 2 against our control group. We will estimate 
confidence intervals for our CERs using bootstrap methods.  
 
We will follow guidelines from implementation science to analyze process evaluation measures 
and the report our findings.  We will address the effectiveness of the different forms of delivery 
of the intervention in the context of a platform for health services at the village level with 
attention to the scalability and sustainability of the intervention. 
8. Ethical Considerations 
8.1 Human Subjects Involvement  
In addition to this request for review by Maseno University Ethics Review Committee 
(MUERC), this protocol will be reviewed by the RAND Human Subjects Protection Committee 
(HSPC) in USA, and by Toronto Academic Health Sciences Network (TAHSN) Ethical Review 
Board (REB) in Canada.   
 
Our research subjects will be Kenyan mothers aged 15 and over (classified as mature minors) 
and their children aged 6-24 months at baseline. For married mothers (the majority in this part of 
Kenya), fathers will also be invited participate as defined in Population section 3. Our study also 
engages Community Health Volunteers (CHVs) as research subjects in the process evaluation as 
described in Process Evaluation section 5.6.  Tables 1 and 2 in Targeted Enrollment section 8.2 
present the number of consents that will be requested for participation in research and 
intervention activities. 
 
Our NGO partner SWAP operates in the proposed study area and has a successful history of 
implementing public health interventions and research studies in the area.  Best practices from 
previous studies will be applied to the delivery of this study and intervention including 
communicating with village leaders and regional authorities in advance of the study.  Care will 
be taken to ensure that there is no undue pressure to participate in the study from the researchers, 
SWAP personnel or local leaders.  Parents who agree to participate in the ECD intervention will 
be encouraged and reminded to participate in the group sessions, but there will be no forcing, 
coercion or penalty for lack of attendance. 

26 
 
8.1.2 Study Participants 
The main respondent of the baseline survey and follow up surveys is the mother, but in married 
households where the father is present we will interview fathers as well in some sections of the 
surveys. The content of the surveys is presented in Measures section 6. Children in the household 
aged 6-24 months at baseline will be included in cognitive and motor development assessments, 
as described in Measures section 6.  A trained interviewer will administer informed consent 
procedures for participation.  For those that express a willingness to continue in the study, the 
interviewer will administer the survey, the expected duration of each survey is 60-70 minutes. 
During this baseline survey we will collect contact information of the household including 
mobile phone numbers to facilitate contacting them in the future.  
 
All households surveyed at baseline will be re-contacted to undergo a follow-up survey roughly 
10-12 months later. Duration, procedures and measures will be identical to the baseline survey. 
The interviewer will reassess the child(ren) assessed at baseline and interview the mother (and 
the father as appropriate).   
 
Roughly two years after this first follow-up survey, all households will again be re-contacted to 
undergo a second follow-up survey. Measures and procedures will be similar to previous survey 
waves. However, for those mothers that have a new child aged 6-24 months at this time point, we 
will additionally assess this (these) younger siblings using the same measures and procedures as 
used on their older siblings at earlier waves.  
 
The pilot survey will follow the same protocol as the baseline survey, but the household will not 
be revisited. 
 
The process evaluations will recruit SWAP CHVs who deliver ECD interventions in study arms 
1 and 2.  During the seven months when the group ECD intervention is delivered, SWAP 
supervisors will observe a subset of sessions.  Following the end of the group ECD intervention, 
exit focus groups will be conducted with CHVs by a trained interviewer, these focus groups will 
be 60-90 minutes in duration.  
 
Table 1 in Targeted Enrollment section 8.2 presents the number of consents that will be 
requested for participation in research activities for the study. 
8.1.2 Intervention Participants 
Following this baseline survey, the randomization of villages to one of three treatment arms will 
take place. Those households in villages assigned to an intervention arm (Arm 1 or 2) will be 
contacted and invited to attend the ECD village sessions, totaling 16 total sessions within the 40 
treatment villages. These sessions will last approximately 90 minutes each and occur on a 
biweekly basis for 7 months from roughly November 2018 through June 2019. Mothers and 

27 
 
children will be invited to all 16 sessions. In half of the villages fathers will also be invited to the 
sessions. Sessions involving both parents will be scheduled on a case-by-case basis in villages to 
encourage maximum attendance by both parents but will fit within the seven-month timeframe of 
the implementation. Attendance at all sessions will be voluntary and recorded by the SWAP 
CHV who will conduct the sessions.  
 
For the 400 households in the 20 villages assigned to Arm 2, they will receive a total of 4 home 
visits during the study’s duration, each roughly 60 minutes in duration. These home visits will 
occur during the seven-month village intervention period to replace the biweekly group sessions. 
During the home visit the CHV will record a series of structured observations on the extent to 
which the mothers (and fathers) are practicing the ECD skills taught in the group sessions at 
home with their children.   
Children between ages 6-24 months at baseline will be included in the study. We will exclude all 
youths outside of this age range for reasons discussed in Rationale for Exclusion section 8.3. 
Children in intervention villages should benefit from increased parental engagement and 
stimulation practices.  
 
For those households in villages randomly selected to receive the extended booters following the 
end of the 16 biweekly sessions, they will be invited to attend roughly 8 additional booster group 
sessions in their villages on a bimonthly basis for an additional 1.5 years between surveys 
beyond the 2 booster sessions planned for the first six months after the main intervention. As 
with the biweekly sessions during the main intervention, attendance will be voluntary and record 
by the SWAP CHV who will conduct the sessions.  
 
8.2 Targeted Enrollment  
 
TABLE 1 
TARGETED/PLANNED VOLUNTARY ENROLLMENT in study  
Sex/Gender 
Females Males 
Total 
Mothers aged 15 and over with children aged 6-24 months  1 
1320 
0 
1320  
Fathers who are aged 18 and older and who are married to 
mothers with children aged 6-24 months (as above)  2 
0 
990 
990 
Children of mothers (as above) aged 6-24 months  3 
726 
726 
1452 
Community Health Volunteers (CHV) who deliver ECD 
interventions  4 
40 
40 
Total  
2086 
1716 
3802 
1 120 mothers in the pilot, 1200 mothers in the baseline survey with repeated measures in two follow up 
surveys. (1200+120=1320) 

28 
 
2 We estimate that 75% of mothers are married to fathers over the age of 18 who are present and able to 
participate in the study. 90 fathers in the pilot, 900 fathers in the baseline survey with repeated measures in 
two follow up surveys. (1200*.75+120*.75=990) 
3 We estimate half of children will be female and half male, with an average of 1.1 children aged 6-24 
months per household at baseline, 132 children in the pilot, 1320 children in the baseline survey with 
repeated measures in two follow up surveys. (120*1.1+1200*1.1=1452) 
4 40 CHVs will deliver the intervention, up to 40 will be selected for participation in the process evaluation 
activities of group session observations and interviews and exit focus groups. 
8.3 Rationale for exclusion  
We will exclude households without children and households with children that are outside the 
age range of 6-24 months at baseline. We will also exclude households with children aged 6-24 
months who are found at baseline to have severe developmental delays. The focus on this age 
range is driven by critical factors. One, most interventions in child psychosocial stimulation 
work with children older than 6 months because for younger children interventions are different 
in nature and more focused on breastfeeding, which is beyond the scope of our project. Another 
reason to focus on children at least 6 months in age is that cognitive and language assessments 
are well developed only for children older than 6 months. Though our initial proposal was to 
include only children aged 6-18 months at baseline, our census of available children in the 
sampled villages is proving that such a tight age range is potentially problematic in order to find 
our required sample size of 1200 children total. We therefore expand to our maximum age to 24 
months for the same reasons. We restrict to children at most 24 months at baseline because 
younger children are more likely to benefit from integrated interventions as the one proposed, 
which should improve our overall ability to detect effects. Additionally, focusing on younger 
ages reduces the number of children who will age out of the Bayley’s III scale by the second 
follow-up survey, which is our preferred primary outcome measure, validated in many low-
income countries for assessing children up to 42 months of age.  
As explained in the ECD Intervention Procedure section 5.4, group ECD sessions will have a cap 
of 20 mother-child dyads per group, who will be randomly invited through lotteries. The 
rationale for this exclusion comes from extensive research showing that group sessions should be 
conducted with no more than roughly 15 participants to be effective. As participation is 
voluntary and because similar interventions have achieved levels of compliance around 75-80%, 
in order to have enough power to detect impacts we will invite 20 households per village.  
Additionally, for purposes of analysis and sample size calculations, we will exclude from our 
sample households with children who are assessed at baseline to have severe developmental 
delays. Severely delayed children are likely to have needs that are beyond the scope of our study 
and thus are unlikely to benefit from a program focused on stimulation and nutrition topics. Any 
identified children with severe developmental delays will be referred by the enumerator to the 
SWAP CHV for consultation with the local health facility. 
 

29 
 
8.4 Sources of Data 
The proposed research involves new primary data collection and analysis. To maintain accurate 
attendance records at ECD sessions as well as to enable recontacting homes for follow-up 
surveys, it is necessary to have temporary access to personally identifiable information including 
name and mobile number. However, such access to study investigators will be made only 
temporarily and we will follow the Data Safety and Monitoring Plan outlined in Section 8.8. 
8.5 Potential Risks 
One potential risk of this study is that during baseline and follow-up surveys, or during the ECD 
interventions, we detect children with severe health problems that require immediate assistance. 
In that event, our CHVs and interviewers will be properly trained to assist the parents in taking 
the child to the closest local health center.  
 
A second potential risk is that CHVs or interviewers detect cases of intra-household violence 
either during the group interventions or in the home visits. We will deal with intra-household 
violence with three approaches.  First, these topics will be included within the curriculum of the 
intervention. Some sessions intend to cover topics of family dynamics and fathers’ engagement. 
In half of the villages, fathers will be invited to these sessions and participate in group activities. 
The group activities of these sessions will be devoted to address family barriers that limit the 
development of a nurturing home environment, focusing on the positive roles of love and respect 
and a positive home environment to improve overall family functioning. Aboud and Singla’s 
experience developing an ECD intervention in neighboring Uganda that also addressed domestic 
violence issues will serve as a guide for how to approach these sensitive issues in group 
dynamics either involving mothers and fathers, or working only with mothers. Second, we will 
also borrow from their experience for the training of CHVs on how to approach family conflicts 
and detected violence episodes during home visits. We will train CHVs and interviewers in the 
plan of action in those events, which will include advising the family to attend the closest local 
health or social assistance center, with a formal recommendation from SWAP as to local 
capabilities and services. They will be also trained to report the cases to the local authorities in 
cases in which the safety and health of the mother/child are seriously compromised. Third, a 
related but rare potential risk is that our joint sessions with mothers and fathers might trigger 
some family conflicts during or after the sessions. Our CHVs will have special supervision in 
how they conduct these sessions by members of the research team of SWAP. Both CHVs and 
supervisors will be properly trained to act accordingly to manage those situations and report 
them if needed.  
 
Another potential risk is that CHVs detect severe cases of maternal depression that require urgent 
assistance. Similar to the case of domestic violence, CHVs will be trained to advise the family to 
attend the closest health center or social assistance center when required, and recommended by 
SWAP.   

30 
 
 
Another potential risk is that CHVs and/or interviewers may suffer any sort of accident when 
traveling to/from the village catchment areas. All the personnel hired by SWAP implementing 
the intervention and surveys are covered by medical insurance provided by SWAP and paid from 
the budget of the current proposal.   
 
Another potential risk is that CHV participation in the process evaluation may reflect poorly on 
their performance as CHVs and risk influencing their relationship with SWAP.  Information 
collected in the process evaluation will not be used to evaluate the CHVs themselves, instead the 
process evaluation will focus on the intervention.  The outcomes of the process evaluation will 
not be used to evaluate individual CHV performance. 
 
Finally, there is a potential risk of losing the data collected in surveys and violation of 
confidentiality, or losing the materials for the interventions.  
 
There are no other risks involved in our project.   
 
8.6 Recruitment and Informed Consent 
As explained above, subjects will be asked for their informed consent for their participation. The 
informed consent will detail the topics to be covered in the group sessions and home visits so 
households know in advance the type of activities they will participate. Similarly, the consent 
will detail the survey measures that will be collected. Participation in surveys and any ECD 
intervention will be strictly voluntary.  
 
8.7 Protection Against Risk 
The preservation of participant confidentiality through the project use of the data is of utmost 
priority to the project team. Access to the data is carefully safeguarded by the RAND 
Corporation Data Facility, and the RAND Human Subjects Protection Committee that comprises 
RAND’s Institutional Review Board. The protection of risks to participants is also safeguarded 
under the RAND “Federal-wide Assurance for the Protection of Human Subjects.” The project 
team will comply with all aspects of data safeguarding specified in the RAND policies and 
procedures on confidential information protection. Protection against risks are described in detail 
in Potential Risks section 8.5.  
 
SWAP has its headquarters in Kisumu, Kenya, where both the Country Director and Technical 
Advisor  have  private locked offices and where the computing environment consists of an 
Ethernet LAN connecting computers and printers for the Country Director, Technical Advisor 
and all SWAP personnel assisting with this project. We will protect the tools, data and materials, 

31 
 
saving these materials in the Country Director’s office, or, as appropriate, inside of one of 
SWAP’s closest Jamii (community) center’s locked offices; the project will further protect the 
property by funding security alarms and guards during the time involving data collection and 
ECD interventions. All SWAP’s research staff members have been trained on research ethics and 
signed confidentiality statements.    
 
We will train CHVs and interviewers in the event of detecting urgent health care needed for any 
family member or the need of social assistance, including advising the family to attend the 
closest local health or social assistance center, or to make a formal report in cases of violence.   
 
8.8 Data and Safety Monitoring Plan 
 
8.8.1 Blinding  
Due to the nature of the intervention, the participants will not be blinded to their study allocation.  
Data collection will, however, be blinded to the intervention allocation status of participants and 
villages at follow-up surveys. (Baseline surveys will be collected prior to randomization.) 
Likewise, data analysis will be blinded to the intervention status of participants and villages.    
8.8.2 Plan for Independent Data Safety and Monitoring 
Survey data collected are generally about individuals' parenting practices, well-being and health 
needs (their own, their families', their communities'), basic wealth indicators and basic attitudes 
towards parenting. We will also collect basic anthropometric data (height and weight) of children 
as well as perform assessments of children’s cognitive and language development using standard 
scales described in our research strategy. Though personal in nature, these data are not highly 
sensitive but it will be equally treated with the maximum norms of confidentiality following the 
study protocols involving human subjects reviewed by the RAND Human Subjects Protection 
Committee (HSPC) as well as the Maseno University Ethical Review Committee (MUERC).  
Risk presented by disclosure of the identity or data provided by study participants is minimal.  
 
Interviews, surveys, and the ECD program are low-risk, and therefore adverse events (AEs) are 
very unlikely and any experienced AEs will be likely due to factors unrelated to the study. Based 
on prior research with this population, we expect some level of maternal depression and, in some 
cases, cases of domestic violence. Thus, adverse events may be related more to these underlying 
issues than to the study itself.  
 
8.8.3 Responsibility for Data Safeguarding  
PI Luoto will oversee data safeguarding. Under her supervision, designated research staff will be 
trained in data safeguarding techniques and will be responsible for the secure transmission of 

32 
 
data from the study tablets using encrypted data collection forms on SurveyCTO in the field in 
Kenya to a secure encrypted server to secure research computers at RAND.  
 
8.8.4 Training of the Data Collection Team  
Prior to data collection, Dr. Luoto will conduct extensive trainings for the designated on-site 
interviewer staff. The training will address data safeguarding and confidentiality. All study staff 
will be trained to promote standardized and objective collection and recording of participant 
information. As part of their training, they will be instructed in the rules of confidentiality and 
data safeguarding for the study. After the initial data collection, RAND will be responsible for 
training the data collection team to manage the uploaded data.  
 
8.8.5 Data Storage and Transmittal  
We will not collect any form of biological samples that require medical procedures of any sort. 
Surveys will be collected via tablets and contain personal identifiers (names), anthropometric 
and psychosocial measures of children, and mobile telephone numbers. Data from tablet-based 
surveys using encrypted forms will be uploaded into SurveyCTO’s encrypted server and 
analyzed using Stata software version 15 (College Station, TX). To increase security over paper 
questionnaires, these will be stored on password-protected mobile devices using encrypted data 
collection forms in the field, and removed at the end of the day by uploading to an encrypted, 
password protected SurveyCTO server. Participant names will be removed from the data and no 
longer stored in any table after the successful linking with a RAND-generated ID. Access to this 
linked file will be restricted only to authorized study staff. Data transfer from the study server to 
study investigators will be done with only encrypted, password-protected files.  
 
All primary data made available to the analysis team will contain only the study ID. Following 
analysis, reports will be prepared. These reports will not contain any data that could identify 
individual clients or staff.  
 
Exported administrative data files will be kept for at least one year following the publication of 
the final reports on the study. Upon the completion of the study, the link files will be destroyed.  
 
Recordings of qualitative interviews will be uploaded to an encrypted RAND computer each day. 
Transcripts from the interviews will be identifiable only by study ID.  
 
8.8.6 Disposition of Data after the Study  
Soft copies of raw data will be kept at RAND offices. Linking files and identifiable information 
will be destroyed within a year after study completion.  

33 
 
8.8.7 Data Integrity  
We have several mechanisms in place to ensure data integrity and confidentiality. All data will 
be stored in a password-protected database. Paper files (i.e., consent forms) will be stored in 
locked file cabinets, and electronic files will be stored in encrypted and password-protected files. 
Furthermore, electronic files will be identified only by participant ID numbers. Identifying 
information linking participants to their study ID number will be retained in an encrypted and 
password protected record management system on RAND's segmented secure server. 
Confidentiality policies and procedures will be reviewed with all new staff and reviewed 
annually with current staff.  
8.8.8 Process for Handling and Reporting Adverse Events (AEs)  
AEs will be handled the same way in which emergencies are handled. Study staff will intervene 
as necessary, assess the participant’s state, and develop an appropriate plan. Incident reports will 
be written within one business day. The PI will inform the IRBs of all AEs. 
8.9 Potential Benefits  
Our project involves three potential benefits. First, the direct benefits of our ECD interventions 
on households. We target teaching households in the intervention arms new child-rearing and 
nutrition practices that potentially can lead to improvements in their children’s health and 
developmental outcomes. Previous experience of our team members in Kenya and other contexts 
is that there will be great interest on the part of mothers to learn the new information and 
practices, and the additional focus on fathers and how they can contribute to their children’s 
positive development could be of significant value to the community. Through Luoto’s and 
SWAP’s previous work with the community leaders, we are hopeful that engagement of fathers 
will also be significant.  
 
Second, there are potential indirect benefits through spillover effects. At the household level, 
while our interventions will target at only one child per family, younger children can potentially 
benefit as well by the adoption of new parenting practices acquired during the intervention. At 
the community level, participants can also potentially transfer knowledge of the new practices to 
non-participants and expand the impacts of our intervention to non-intended targets.  
 
Finally, households that are surveyed at baseline and follow-up either in the treatment or control 
arms can benefit from the intervention by learning from the survey results. Our evaluation team 
is committed to feedback to the families about the results of maternal and child assessments and 
with individualized recommendations to improve parental practices and child developmental 
outcomes and has budgeted for travel in the final year of the project to disseminate findings 
locally. In the final year of the project, research team members plan dissemination workshops to 
share findings with the County Health Management Teams, County Executive Member of 
Education and Local Administrative  Leaders. 

34 
 
 
9. Implications of Research 
Our study will provide policy makers with rigorous evidence of how best to expand ECD 
interventions in low-resource rural settings to improve child developmental outcomes for both 
the short-and longer-term. The study will try to understand how to maximize the reach and 
sustained impact of evidence-based early child development curriculum and materials to improve 
child cognitive, language and psychosocial outcomes. In low-income and middle-income 
counties 43% of children under five years of age have compromised cognitive and psychosocial 
development, and these deficiencies are tightly linked to inadequate nutrition, lack of 
psychosocial stimulation and other poverty correlates. We test potentially scalable and 
sustainable models of delivery and explore via complex Decomposition Analysis whether and 
how the intervention’s impacts can be sustained over time. Our project will also be the first to 
experimentally test for the presence of spillovers of impacts within families onto younger 
children, which is a clear sign of sustained behavioural change on the part of the parents.  
 
By integrating delivery into the ongoing operations of a well-established local NGO, our project 
has the potential to make a real and sustainable contribution in a resource-limited setting and 
lessons learned are potentially adaptable to other similar settings and organizations. Because our 
main goal is to test the most cost-effective model of delivery for rural Kenya, important lessons 
from our project can be extracted to scale-up similar intervention in similar contexts. 
 
Due to the fact that very minimal risk is placed on the participants through the proposed 
research, the importance of the knowledge to be gained is greater than the risks to the subjects 
 
 
10. Challenges and Limitations 
 
The proposed intervention seeks to attain sustained changes in parental child-rearing practices and 
child developmental outcomes to test for the most cost-effective and scalable models of delivery 
of this intervention, and to evaluate the impact of involving fathers in such an intervention. We 
acknowledge several challenges and limitations that might prevent us to achieve these goals and 
strategies to overcome them.  
First, an important challenge to achieve one of the study goals is to engage fathers so they 
participate in the group sessions in villages in which fathers are included. While engaging mothers 
has been proven to be successful in similar interventions conducted by co-Investigators Aboud and 
Singla in Uganda (where more than 75% of mothers invited showed-up to the sessions), we 
anticipate that encouraging father’s participation and adherence will be more challenging. Fathers 

35 
 
usually work during the day or they are absent during longer periods of time working in another 
region, but even if they are present, they typically are less involved in child-rearing activities. At 
this point it is not obvious to us whether conducting sessions with fathers and mothers together or 
having at least few sessions separately first is more convenient, an issue we will address during 
piloting.  In order to increase father participation we have adopted several strategies. First, prior 
to research activities SWAP will conduct community entry work to promote our intervention in 
the villages committing village elders to encourage fathers to participate and attend some of the 
sessions themselves. Second, we will pilot group sessions only with fathers (particularly the first 
ones) so they feel more comfortable with the topics discussed, scheduling them at times of the day 
that are more appropriate for them. Third, the piloting schedule will test different orders of sessions 
and modalities of attendance (fathers only and mothers only v/s together) to test for the design that 
maximizes attendance and adherence. Finally, the pilot will also evaluate alternative incentives to 
increase participation such as providing certificates of attendance, etc.  
A second potential limitation of our study is our ability to inform policy about what drives 
sustained impacts and spillover effects onto younger siblings if we find any during the second 
follow-up survey. In particular, we will have the challenge to explain what aspects of our 
intervention induced sustained changes in maternal and paternal behaviors driving our results. Is 
it because of our intervention improved maternal or paternal mental health? Or they improved the 
social support? Or changes in behaviors are instead due to a higher knowledge of child 
development or to a change in beliefs and attitudes? While all these questions would ideally be 
tested incorporating more treatment arms, that would make the study too costly to be implemented. 
Instead, our strategy to address these questions would rely on collecting very rich data about each 
potential mediator of behavioral change such as mental health, social support, self-efficacy, 
knowledge and beliefs and test for their relative importance as shown in Figure 1 combining this 
data with state-of-the-art statistical methods of mediation analysis. To the extent that our 
interventions would show impacts two years after the group sessions take place in child outcomes 
and behaviors, our methods would open the black box addressing the pathways of change, allowing 
us to design better interventions in the future.  
Third, we will face several challenges regarding measurement. For example, the application of the 
Bayley III scale to assess child development has been reported to be logistically difficult and 
expensive because it involves direct assessment with children using a complete kit of 
manipulatives. This requires the child to be in the appropriate mood for the test and the presence 
of the mother to assist the enumerator in accomplishing each activity with the child. To address 
this issue we have adopted two strategies. First, at baseline we will use a child assessment that is 
based on maternal self-report (the MDAT scale) and therefore is simpler to implement. The 
baseline data will be collected only for the purposes of testing the balance of the sample, so there 
is no need to use more sophisticated scales such as the Bayley, which will be used instead to 
measure impacts. Second, before implementing the Bayley III in the follow-up survey we will pilot 
its application in subsample of mothers. 

36 
 
Finally, although the pilot study did not identify a significant risk of participant contamination, 
this remains a possible risk in a cRCT of this nature.  While CHVs catchment areas will be mapped 
and selected villages will not overlap to secure that households in control villages do not attend 
the sessions in contiguous treatment villages, this risk cannot be eliminated entirely. Thus, our 
sampling strategy will incorporate mapping villages separated by a healthy distance, with the 
expectation that the high costs of travelling to more distant treatment villages will outweigh the 
perceived benefit of participating in the intervention. Moreover, we will work closely with SWAP 
during the sample stage to identify concurrent interventions from other NGOs in the pool of pre-
selected villages to avoid overlapping whenever possible, and when it is not possible, to document 
those interventions to incorporate this information to our statistical analyses. 
 
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12. 
List of attachments 
12.1 Roles and responsibilities  
Dr. Jill Luoto, Ph.D. Dr. Luoto is an Economist at RAND and will be the Principal Investigator 
(PI) for this project. As Principal Investigator, she will lead the research team assembled and be 
responsible for designing and executing the proposed research in pursuit of its Aims. She has 
served as PI on randomized field studies implemented by SWAP before in this part of Kenya on 
related topics to those proposed here, and is well prepared to handle these tasks.  
 
Dr. Italo Lopez Garcia, Ph.D. Dr. Lopez Garcia is an Associate Economist at RAND and will 
serve a central role as co-investigator in this project to assist Dr. Luoto in all aspects of project 
execution. He brings key topical expertise in structural econometric techniques to the study team. 
He will lead the design and piloting of the survey questionnaires and the decomposition analysis 
in study Aim 3 using both rounds of follow-up survey data.  
 
Dr. Frances Aboud, Ph.D. Dr. Aboud is Full Professor of Psychology at McGill University and a 
seminal figure in early childhood development programs and interventions in LMIC settings. She 
is an internationally recognized expert in developmental psychology with specific expertise on 
infants and toddlers who brings considerable expertise with decades of invaluable experience. She 
will offer senior guidance and advice on key elements of intervention and curriculum design and 
interpretation of findings. She will lead the trainings of CHVs into the curriculum and will 
supervise implementation of some ECD village sessions at the midway point as a quality control 
measure.  
 
Dr. Lia Fernald, Ph.D. is an Associate Professor in Community Health and Human 
Development at the School of Public Health at the University of California, Berkeley. Dr. 
Fernald is an internationally recognized nutrition and child development expert with numerous 
studies evaluating the impacts of programs and interventions for child development in 
developing countries and studying the role of poverty on child outcomes. Dr. Fernald will 
oversee the design and implementation plans for the home visits in study Arm 2 and will offer 
senior guidance.  
Dr. Daisy Singla, Ph.D. is Assistant Professor and Senior Scientist at the Department of 
Psychiatry at the University of Toronto and Mount Sinai Research Institute.  She has conducted 
integrated randomized trials related to parenting interventions in Uganda and Bangladesh, and 
has particular expertise in maternal mental health. She will assist in the training of CHVs and 
will lead the formative exit interviews of pilot participants as well as the process evaluation.  
Alie Eleveld, MPH. Ms. Eleveld is the PI on the subcontract to SWAP and will be the main point 
of contact between foreign and Kenya-based implementation team members. She oversees all 
SWAP operations and provides technical support and strategic direction, will monitor 
compliance with MOUs and reporting guidelines. She will lead dissemination efforts in Kenya 
and assist with writing reports.  

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George Aol Otieno. Mr. Otieno will be the survey manager for the survey data collection and 
will oversee the team of enumerators and manage field logistics for the baseline and follow-up 
surveys as well as the piloting of the survey instrument and its measures.  
 
 
 
 
 

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