Achieving Sustained Early Child Development Impacts at Scale: a Kenyan RCT

Study Overview
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Brief Summary
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An estimated 43% of children under age 5 in low- and middle-income countries (LMICs) experience compromised development due to poverty, poor nutrition, and inadequate psychosocial stimulation. Numerous early childhood development (ECD) parenting interventions have been shown to be effective at improving ECD outcomes, at least in the short-term, but they are a) still too expensive to implement at scale in low-resource and rural settings, and b) their early impacts tend to fade over time in the absence of continued support. New ways to deliver effective ECD parenting interventions are sorely needed that are both low-cost to be potentially scalable, while also able to sustain impacts long-term. The rapid growth and low cost of mobile communications in LMIC settings presents a potentially promising solution to the competing problems of scalability and sustainability. Yet there is no rigorous research on mobile-health (mHealth) interventions for ECD outcomes in LMIC settings. We recently showed that an 8-month ECD parenting intervention featuring fortnightly group meetings delivered by Community Health Workers (CHWs) from Kenya's rural health care system significantly improved child cognitive, language, and socioemotional development as well as parenting practices, and our group-based delivery model was more cost-effective than previous ECD interventions. Yet it is still too expensive for scaling in a rural LMIC setting such as ours, particularly if we need interventions that can be extended for longer periods of time to increase their ability to sustain impacts. Our proposed study experimentally tests a traditional in-person delivery model for an ECD parenting intervention against an mHealth-based delivery model that partially substitutes remote delivery for in-person meetings. Kenya is an ideal setting for testing mHealth programs given its high penetration of mobile phones (94%). We will assess the relative effectiveness and costs of this hybrid-delivery model against a purely in-person model, and extend the interventions over two years to increase their ability to sustain changes in child outcomes longer-term. Our evaluation design is a clustered Randomized Control Trial across 90 CHWs and their associated villages and 1200 households. We hypothesize that a hybrid ECD intervention will be lower cost, but remote delivery may be an inferior substitute for in-person visits, leaving open the question of the most cost-effective program. Our goal is to determine the best model to maximize the intervention's reach and sustained impacts to improve child outcomes. By integrating delivery into the ongoing operations of local CHWs within Kenya's rural health care system, utilizing new low-cost technology, and involving local ECD policymakers and stakeholders as key collaborators from the project's inception, our project has the potential to make important contributions towards discovering potentially scalable, sustainable solutions for resource-limited settings.

Official Title
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Achieving Sustained Early Child Development Impacts at Scale: a Kenyan RCT

Conditions
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Language, Child, Child Development, Child Behavior

Intervention / Treatment
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* Behavioral: Msingi Bora responsive parenting and family wellbeing program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible mother-child dyads will be defined by 1) mothers or other primary caretakers aged 18 years or older, 2) able to read English or Swahili at a level sufficient to understand the SMS messages, and 3) with a child aged 6-18 months at recruitment without signs of severe mental or physical impairments. If the mother has more than one child aged 6-18 months at baseline, we will invite the youngest to participate. If the primary caretaker of an otherwise eligible child is the father or another male relative, he will be eligible for inclusion in our study, though we expect the vast majority of primary caretakers of children in this age range will be women, predominantly mothers. For simplicity we refer to this group as mothers. Exclusion Criteria: Mothers/households without children and households with children that are outside the age range of 6-18 months at baseline. Mothers who lack basic literacy.

Ages Eligible for Study
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Minimum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-Person Group Delivery<br>A total of 30 villages will receive a traditional in-person group-based delivery for an ECD parenting intervention featuring 16 biweekly village sessions over 8 months, followed by monthly booster meetings for 16 additional months. Sessions will be delivered within by existing village Community Health Volunteers (CHVs). Mothers and children will be invited to attend a total of 32 in-person sessions of roughly 1.5-2 hours apiece over 24 months. | Behavioral: Msingi Bora responsive parenting and family wellbeing program<br>* Msingi Bora's structured curriculum of 16 biweekly sessions and monthly boosters thereafter are organized around five key messages: love and respect within the family, responsive talk, responsive play, hygiene, and nutrition.<br>|
| Experimental: Hybrid mHealth/In-Person Group Delivery<br>30 CHVs will deliver a hybrid intervention that combines in-person meetings with remote delivery. The curriculum content will be the same as in the in-person Arm 1, but some sessions will be substituted with remote delivery. Mother-child dyads will be invited to participate in roughly 10 in-person group sessions in the first 8 months, followed by 5 in-person group sessions over the next 16 months. For those sessions delivered remotely, mothers will receive videos demonstrating the practices, SMS messages, be invited to participate in group SMS/WhatsApp chats with the CHV and other village mothers, and periodic phone calls. The project will provide smartphones to all mothers assigned to this arm for facilitation. | Behavioral: Msingi Bora responsive parenting and family wellbeing program<br>* Msingi Bora's structured curriculum of 16 biweekly sessions and monthly boosters thereafter are organized around five key messages: love and respect within the family, responsive talk, responsive play, hygiene, and nutrition.<br>|
| No Intervention: Control Group<br>Mothers and children in 30 villages will not receive any intervention beyond information about child feeding during a baseline survey. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Cognitive Development | Bayley-III cognitive score | Midline/8-month survey, Endline/24-month survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Cognitive Development | Global Scales for Early Childhood Development (GSED) - Long Form | Midline/8-month survey, Endline/24-month survey | 
| Parenting Behaviors | Home Observation for Measurement of the Environment (HOME) Inventory | Midline/8-month survey, Endline/24-month survey |