Family and Childhood Development: Kizazi Kijacho ('The Next Generation') - a Cluster Randomised Controlled Trial
Phase: NA
Conditions: Parenting, Early Child Development
Sponsor: Stockholm University

Pre-analysis plan
Family and Childhood Development: Kizazi
Kijacho (“The Next Generation”) - a Cluster
Randomised Controlled Trial
Ingvild Alm˚as, Orazio Attanasio, Theresa Betancourt, Marc H. Bornstein,
Bet Caeyers, Ester Elisaria, Pamela Jervis, Honorati Masanja,
Costas Meghir, Marianne Moreira, Pallavi Prabhakar, Charlotte Ringdal
NCT number: XX
November 13, 2022
Contents
1
Introduction
2
2
Research strategy
2
2.1
Research Design
. . . . . . . . . . . . . . . . . . . . . . . . . . .
2
3
Study setting
4
4
Randomization, participants, and recruitment
4
4.1
Randomization . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
4.2
Recruitment and participants . . . . . . . . . . . . . . . . . . . .
5
5
Primary and secondary outcome variables and analysis
5
5.1
Primary outcome measures
. . . . . . . . . . . . . . . . . . . . .
5
5.2
Secondary outcome measures . . . . . . . . . . . . . . . . . . . .
6
5.3
Evaluation of Parenting and Unconditional Cash Transfer – Focus
on Child Development . . . . . . . . . . . . . . . . . . . . . . . .
7
5.4
Power calculations . . . . . . . . . . . . . . . . . . . . . . . . . .
7
6
References
8
1

1
Introduction
This is the pre-analysis plan for the early child development (ECD) research
program in Tanzania entitled “Kizazi Kijacho” (The Next Generation)1.
Digital solutions can significantly improve the delivery of ECD services in
Low- and Middle-Income Countries (LMICs). Traditional home-visits and com-
munity group-based parenting approaches require intense levels of training, men-
toring and supervision of Community Health Workers (CHWs) that is difficult to
sustain when transitioning to scale. Context relevant digital tools can support
CHWs in delivering high-quality, respectful, and standardised multi-sectoral
household ECD services by tailoring services to pregnant women and engag-
ing male caregivers. This could have significant impacts on child development,
including stimulation, speech and language development, nutrition, and cogni-
tion. Moreover, cash delivered through digital modes of payment is faster, safer,
easier to administer, is scalable and has potential to empower women, influ-
ence parental investment and affect household decision making. Our study will
conduct a clustered multi-arm Randomised Controlled Trial (cRCT) targeting
pregnant mothers across all 8 district councils in the Dodoma region in Tanza-
nia. Following the study sample for 15 months from 5-7 months pregnancy. The
study will test and compare the causal effects of (i) a digitally supported parent-
ing intervention delivered by CHWs, which aims to improve caregivers’ access
to quality ECD services; (ii) a mobile unconditional cash transfer which aims
to relax financial resource constraints; and (iii) a digitally supported parenting
intervention when combined with a mobile unconditional cash transfer. Find-
ings from our study are expected to have important policy implications for the
design of scalable ECD interventions targeting pregnant mothers in Tanzania
and other LMIC settings.
2
Research strategy
The clustered multi-arm RCT has been designed to test the causal effects of a
novel ECD intervention on children’s cognitive, speech and language develop-
ment and children’s nutritional status, as well as on two secondary outcomes:
children’s socio-emotional development and parents’ child rearing practices.
2.1
Research Design
The clustered multi-arm RCT has four main study arms:
1. No Intervention - Control: This arm will serve as the Control group (81
Health Dispensaries (HDs), 81 communities, 810 households) to identify
the effects of a Parenting only, Unconditional Cash Transfer (UCT) only,
1The study is funded by the Swedish Research Council (project 2020-04650 and 2021-
04740), Norwegian Research Council (project 325566), European Research Council (project
101044994), Foreign, Commonwealth & Development Office – FCDO (project 10087), and
FAIR Norwegian School of Economics (project 262675).
2

and Parenting+UCT interventions.
Caregivers will continue benefiting
from a traditional government CHW home visit program, focusing on
maternal and child health and nutrition, which is currently in practice in
Tanzania.
2. Experimental - Parenting only: 88 HDs, 77 communities, 770 households.
Existing CHWs will be trained to use an innovative digital application
for the delivery of integrated ECD services to mothers who are at least
20 weeks pregnant and less than 32 weeks pregnant for a period of 15
months. CHWs will provide tailored ECD services (e.g., prompting mes-
sages tailored to child age and triggering follow-up visits conditional on
changing conditions), covering all aspects of the Nurturing Care Frame-
work (Health, Nutrition, Responsive Caregiving, Early Learning, Safety
and Security (WHO, UNICEF, World Bank Group, 2018)). Real time data
will be recorded by the CHWs in each visit using the application. Data
will include information on visit attendance, activities conducted, home
environment, caregiver practices, and CHW observations. From when the
target child is 6 months old, group sessions will be organised by CHWs,
focusing on caregiver-child interaction and stimulation activities. The dig-
ital system will be an integrated digital ECD service delivery solution to
support CHWs with this level of decision support and tailored care.
3. Experimental - Parenting+Unconditional Cash Transfer: 88 HDs, 77 com-
munities, 770 households. In addition to the Parenting only intervention,
pregnant women in the study sample will receive a bi-monthly uncondi-
tional mobile money transfer of 77,000 TZS (33 USD) from 5-7 months
pregnancy over a period of 15 months (7 transfers in total).
4. Experimental - Unconditional Cash Transfer only fixed amount: 89 HDs,
80 communities, 800 households. Households, in addition to the CHWs
delivering health and nutrition services as usual, will receive a fixed bi-
monthly unconditional mobile money transfer each of 109,000 TZS (47
USD) from 5-7 months pregnancy over a period of 15 months (7 transfers
in total). The bi-monthly cash transfer equals the sum of (i) the average
of maximum and minimum bi-monthly cash transfer amount disbursed
per family under Tanzania Social Action Fund (TASAF), i.e. Tanzania’s
flagship nationwide social protection scheme (77,000 TZS, 33 USD) and
(ii) the bi-monthly cost per additional family of delivering a parenting
intervention (32,000 TZS, 14 USD). The transfer will be randomly assigned
between mothers and fathers/spouses within each community, where in
half of the eligible households, mothers will receive the transfer and in the
other half, fathers/spouses (or household head where the father/spouse is
not available) will receive the transfer.
In addition to these four main treatment arms, there is another UCT only treat-
ment study group where the levels of the cash amounts vary across communities.
In this treatment group, the Unconditional Cash Transfers only vary amount
3

(89 HDs, 75 communities, 375 households), in addition to the CHWs deliver-
ing health and nutrition services as usual, communities will be randomised to
receive one of the bi-monthly unconditional mobile money transfer amounts:
32,000 TZS (14 USD), 77,000 TZS (33 USD), 109,000 TZS (47 USD) from
5-7 months pregnancy over a period of 15 months (7 transfers in total). The
transfers will be randomly assigned between mothers and fathers/spouses within
each community, where in half of the eligible households, mothers will receive
the transfer and in the other half, fathers/spouses (or household head where the
father/spouse is not available) will receive the transfer.
3
Study setting
The clustered multi-arm RCT is planned to be conducted in Dodoma region of
Tanzania, a region where EGPAF, the implementing partner, has substantial
experience and networks but where CHWs have not yet provided any Care for
Child Development services other than health and nutrition (e.g. child stimu-
lation) and where CHWs have not yet been supported by a digital application
in the delivery of ECD services. All 258 public health dispensaries catchment
areas (with at least one registered CHW) across all 7 districts (and all 8 district
councils) in Dodoma region will be included: Bahi DC, Chemba DC, Chamwino
DC, Mpwapwa DC, Kongwa DC, Kondoa DC (town council and district coun-
cil), and Dodoma City.
4
Randomization, participants, and recruitment
4.1
Randomization
The randomization will be done in the following steps:
• All public HDs will be identified in the Dodoma region with at least one
officially registered CHW, 258 HDs in total.
• These study HDs will be randomized to either (i) the Control group (81
HDs), (ii) the UCT only group (89 HDs), or (iii) the Parenting group
(88 HDs). The randomization will be stratified by district council and
by whether there is more than one village or ’mtaa’ (city block in urban
areas) served by the HD (i.e. in the HD catchment area).
• In the 81 Control HDs, one village/mtaa with at least one officially regis-
tered CHW will randomly sampled to participate in the study. In the 88
Parenting HDs and the 89 UCT only HDs all villages/mtaas (with at least
one officially registered CHW) in their catchment areas will be included to
participate in the study. In total, that will give 390 study villages/mtaas
in the study sample.
• Within each of these study villages/mtaas, one officially registered CHW
will be randomly selected and include the catchment area of that CHW
4

as a study ’community’ in the study sample, where study community is
defined as CHW catchment area. This could be the entire village/mtaa
or a sub-village/mtaa, depending on the size of the village/mtaa and the
number of CHWs working in the village/mtaa.
• Within the UCT only group (155 study communities across 89 HDs),
study communities will be randomly assigned, stratified by HD, to: (i)
UCT only fixed amount treatment arm (80 communities) and (ii) UCT
only vary amount treatment arm (75 communities).
In the Parenting
group (154 communities across 88 HDs), study communities will be ran-
domly assigned, stratified by HD, to: (i) Parenting only treatment arm (77
communities) and (ii) Parenting+UCT treatment arm (77 communities).
4.2
Recruitment and participants
The aim is to sample and survey for the study a total of 3525 pregnant women
aged 18 years or above, who are living in the select study communities and who
are at least 20 weeks pregnant and less than 32 weeks pregnant at the time of the
baseline data collection survey visit to the study community region, Tanzania:
a target of 10 women per community in the Control group, in the Parenting
only treatment arm and in the UCT only fixed amount treatment arm and a
target of 5 women per community in the UCT only vary amount group.
5
Primary and secondary outcome variables and
analysis
5.1
Primary outcome measures
• Children’s cognitive and speech and language development: Cognitive and
language development at the time of the endline survey will be assessed.
To do so, direct assessment and parental report will be combined. For
direct assessment, the third version of the Bayley Scales of Infant and
Toddler Development 3rd edition (Bayley-III; Bayley (2006)) will be used,
suitably adapted for the context and provides measures up to 42 months
of age. Cognition, receptive and expressive language subtests will be used.
For parental report, selected items of the Caregiver Reported Early De-
velopment Instruments (CREDI; McCoy et al. (2018)) for cognition and
receptive and expressive language subtests which provides measures up
to 36 months of age, and a short versions of the MacArthur-Bates Com-
municative Development Inventory (Jackson-Maldonado et al., 2013) that
measures expressive language up to 30 months will be used. Both of these
have already been adapted for Tanzania and are free. Raw scores will be
standardized within the study sample for analysis.
• Children’s nutritional status: Weight and height will be measured at the
time of the follow-up survey to obtain the height-for-age-z-scores and
5

weight-for-height-age-z-scores, standard measures outlined by WHO. Mid
Upper Arm Circumference (MUAC) will be also collected (WHO, 2006).
Scores will be standardized within the study sample for analysis, so all
measures are in the same metric.
We will aggregate the measurement of outcomes using Structural Equation
Modeling (SEM) to get latent factor(s) that summarizes effectively the infor-
mation given by the individual items. We will combine direct assessment and
parental reports as well as the different child development domains and nu-
tritional outcomes if the fit of the model(s) are better than using the original
scoring techniques.
5.2
Secondary outcome measures
• Children’s socio-emotional development: Socio-emotional development at
the time of the endline survey will be assessed. To do so, direct assessment
and parental report will be combined. For direct assessment, the Griffiths
Developmental Scale III (Griffiths, 1970) personal-social-emotional sub-
test, suitably adapted for the context, will be used. For parental report,
selected items of the Caregiver Reported Early Development Instruments
(CREDI) (McCoy, Marcus and Gunther, 2018) for the socio-emotional
subtest which is already adapted for Tanzanian context and is free to use
will be used. Raw scores will be standardized within the study sample
for analysis. The measurement of outcomes will be aggregated using SEM
to get latent factor(s) that summarizes effectively the information given
by the individual items. Direct assessment and parental reports will be
combined if the fit of the model(s) are better than using the original raw
scoring techniques were higher scores mean better outcomes.
• Child rearing practices - level of stimulation in the home: The presence
of toys and learning materials in the house will be assessed together with
parental involvement with the child, the child’s routines and organisa-
tion of the child’s time inside and outside the family house. This will be
assessed using the Family Care Indicators, developed by UNICEF (FCI;
(Kariger, et al, 2012)), and possibly selected subscales of the Home Obser-
vation for the Measurement of the Environment (HOME; (Bradley, 2014))
and the Parental Style (PSQ; (Bornstein et al, 1996)) for assessing social
and didactic interactions. The measurement of outcomes will be aggre-
gated using SEM to get latent factor(s) that summarizes effectively the
information given by the individual items on time and monetary parental
investments.
Additionally, information on household characteristics, family background
variables and maternal depressive symptoms will be gathered.
How the impacts vary by gender of the child and maternal education at
baseline will be further examined.
6

5.3
Evaluation of Parenting and Unconditional Cash Trans-
fer – Focus on Child Development
For the impact evaluation of the Parenting and UCT, Parenting only, UCT
only fixed amount, and Parenting+UCT will be compared to the Control group
on outcome yi for child i, and also the treatments arms (Parenting only, UCT
only fixed amount, and Parenting+UCT) to each other. The child development
outcomes will be scaled to have mean 0 and standard deviation 1 amongst
target children in the Control group. Equation (1)2 evaluates the impacts of
each treatment.
yi = α + θsTi,s + γagei + δX + εi,
(1)
where Ti,s is the treatment status for individual i where s indicates the treat-
ments (Parenting only, UCT only fixed amount, and Parenting+UCT, respec-
tively).
agei is the age of the child (months) at endline and X is a vector
of observable household characteristics and family background variables to in-
crease precision of the estimates. The covariates are district, tester ID, gender
of the child, and maternal education. In addition, the estimation will control
for any potential imbalances between treatments arms and between treatments
arms and Control group.
All standard errors will be clustered at the HD CHW catchment area level.
Additionally, multiple testing for the two primary outcomes will be performed.
Step-down p-values using the general results of Romano and Wolf (2010) will
be reported.
5.4
Power calculations
A sample of 10 households within each of approximately 80 study communities
in each of the study groups in the cRCT gives 80 percent power for a two-tail
tests of size 5% to detect improvements in child development outcome larger
than 18-27% of a standard score (for the primary outcomes), assuming attrition
of 10% (yielding a target sample size of 9 households within each community)
and intra–cluster correlations between 0.1 and 0.3 for any pairwise comparison
with the Control group. This sample size also allows to detect impacts larger
than 24-30% for boys and girls sub-groups (expected on average at least 4 boys
and 4 girls in the random sample of 9 children).
2Note that for the child development measures, it is not possible to run ancova specifica-
tions, as the child is not born at baseline.
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6
References
Bayley, N., Bayley scales of infant and toddler development. PsychCorp.,
Pear- son, 2006.
Bornstein, M. H., Tamis-LeMonda, C. S., Pascual, L., Haynes, O. M., Painter,
K., Galper´ın, C., Pˆecheux, M.-G. Ideas about parenting in Argentina, France,
and the United States. International Journal of Behavioral Development, 1996,
19, 347-367. https://doi.org/10.1177/016502549601900207
Bradley, R. H, “The HOME environment,” in Marc H. Bornstein, ed., Hand-
book of Cultural Development Science, New York: Psychology Press, 2014, pp.
505–530.
Griffiths, R., The abilities of young children: A comprehensive system of
mental measurement for the first eight years of life, London: Child Development
Research Centre, 1970.
Jackson-Maldonado, Donna, Virginia A Marchman, and Lia C H Fernald,
“Short-form versions of the Spanish MacArthur-Bates Communicative Develop-
ment Inventories,” Applied Psycholinguistics, 2013, 34, 837–868.
Kariger, Patricia, Edward A. Frongillo, Patrice Engle, Pia M.Rebello Britto,
Sara M. Sywulka, and Purnima Menon, “Indicators of family care for develop-
ment for use in multicountry surveys,” 12 2012.
McCoy, Dana Charles, Marcus Waldman, and G¨unther Fink, “Measuring
early childhood development at a global scale: Evidence from the Caregiver-
Reported Early Development Instruments,” Early Childhood Research Quar-
terly, 10 2018, 45, 58–68.
Romano, Joseph and Michael Wolf, “Balanced control of generalized error
rates,” The Annals of Statistics, 2 2010, 38 (1), 598–633.
World Health Organization, United Nations Children’s Fund, World Bank
Group.
Nurturing care for early childhood development:
a framework for
helping children survive and thrive to transform health and human potential.
Geneva: World Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO.
World Health Organization, “WHO child growth standards: length/height-
for-age, weight-for-age, weight-for-length, weight-for- height and body mass
index-forage: methods and development.,” World Health Organisation, 2006,
pp. 1–312.
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