Testing Means to Scale Early Childhood Development Interventions in Rural Kenya

Study Overview
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Brief Summary
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This study 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 also include 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. Findings 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.

Detailed Description
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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. This 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 the study 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 non-governmental organization (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.

Official Title
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Testing Means to Scale Early Childhood Development Interventions in Rural Kenya

Conditions
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Early Child Development

Intervention / Treatment
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* Behavioral: Group sessions
* Behavioral: Group+Home sessions
* Behavioral: Booster sessions
* Behavioral: Fathers invited


Participation Criteria
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Eligibility Criteria
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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 The unit of observation for the study is the household or family, within which the primary focus is mother-child dyads and household eligibility hinges on the age of the child. For those households with a father present, the study will additionally include him in some analyses and surveys. Exclusion Criteria: Households without children Households with children that are outside the age range of 6-24 months at baseline 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.

Ages Eligible for Study
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Minimum Age: 15 Years

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: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: The evaluation design is conducted in two phases. During phase 1, a clustered Randomized Control Trial (cRCT) across 60 community health volunteers (CHVs) and their associated villages are randomly assigned to one of three equally-sized treatment arms: group meetings for 16 biweekly sessions over 8 months (Arm 1), 12 group meetings plus 4 home visits over 8 months (Arm 2), and a control group (Arm 3). Within half of villages assigned to Arms 1 and 2, fathers will also be invited to the sessions (a 2x2 factorial design among the 40 villages assigned to receive the intervention). After a first follow-up survey immediately after the end of the biweekly sessions, in phase 2 we stratify by Arms 1 and 2 and re-randomize villages so that 20 total receive booster group sessions every 2 months over another 2 years (10 each from Arms 1 and 2). The other 20 villages from Arms 1 and 2 do not receive extended boosters.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 (group sessions)<br>Group meetings only (16 total) | Behavioral: Group sessions<br>* Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.<br>|
| Experimental: Arm 2 (group+home sessions)<br>Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) | Behavioral: Group+Home sessions<br>* 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.<br>|
| No Intervention: Arm 3<br>This arm will serve as the control group to identify the effects of a parenting intervention and the most effective mode of delivery, as well as the sustained impacts from the intervention | |
| Experimental: Arm B (Booster villages)<br>In one half of Arm 1 and Arm 2 villages above, after the end of the main intensive intervention, extended light-touch group booster sessions held every other month over two years between the two follow-up surveys will be held | Behavioral: Group sessions<br>* Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.<br>Behavioral: Group+Home sessions<br>* 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.<br>Behavioral: Booster sessions<br>* After the end of the 16 biweekly sessions (phase 1), we will re-randomize across the 40 intervention villages, stratified by Arms 1 and 2, and half of each of Arm 1 and Arm 2 villages will receive group booster visits every other month for the period between end-line and follow-up surveys. This will constitute Phase 2 of the study.<br>|
| Other: Arm A (Non-booster villages)<br>In the other half of Arm 1 and Arm 2 villages, no boosters will be held during phase 2 | Behavioral: Group sessions<br>* Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.<br>Behavioral: Group+Home sessions<br>* 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.<br>|
| Experimental: Arm X: Fathers invited<br>During phase 1, fathers were invited to attend sessions in half of Arms 1 and 2 villages. | Behavioral: Group sessions<br>* Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.<br>Behavioral: Group+Home sessions<br>* 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.<br>Behavioral: Fathers invited<br>* During phase 1's 16 biweekly sessions, in half of Arm 1 and Arm 2 villages (20 total), fathers will additionally be invited to attend the 16 sessions. Separate father-only sessions will be held for 4 of the 16 sessions. This randomization will end after phase 1.<br>|
| Other: Arm Y: Fathers not invited<br>During phase 1, fathers were not invited in the other half of Arms 1 and 2 villages. | Behavioral: Group sessions<br>* Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.<br>Behavioral: Group+Home sessions<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Developmental Outcomes | The Bayley Scales of Infant Development 3rd edition (Bayley's III), is validated in African settings and provides measures for all dimensions of child development up to 42 months of age. The official age-standardized cognitive, receptive language, and expressive language scales have 0-19 ranges with higher values denoting better scores. At month 11/endline survey, cognitive, receptive language, and expressive language scales were collected. At baseline, cognitive and receptive language were collected. Month 11 reported here. Baseline outcomes reported elsewhere. | Month 11/Endline after end of Phase 1's 16 biweekly sessions (Arm 1 with & without fathers, Arm 2 with and without fathers, and Arm 3). Arms A and B created after the Month 11/Endline survey. | 
| Child Developmental Outcomes | Block-design subtest of the Wechsler Preschool and Primary Scale of Intelligence - 4th Edition (WPPSI-IV) to measure cognitive non-verbal reasoning. This subtest produces an age-standardized scaled score that can range from 1 to 19, with higher scores denoting better outcomes. For expressive and receptive language we used Dholuo and Kiswahili versions of the British Picture Vocabulary Scale - III (BPVS III), which includes 168 items for use with ages 3-17 years old. Knowledge of receptive vocabulary is measured by asking the respondent to point to one of four pictures that corresponds to a word (object, person, or action) spoken by the assessor; for expressive vocabulary the assessor pointed to a picture and the child named it. Pictures were adapted to the Kenyan context previously. Raw language scale ranges 0-25 with higher values denoting better outcomes. | Month 35-37/Follow-Up survey (Arms 3, A and B), two years after end of Phase 1's 16 biweekly sessions | 
| Parenting Practices (HOME Observation for Measurement of the Environment - HOME) | At follow-up surveys, the study will collect the Home Observation for Measurement of the Environment (HOME)- Short Form (SF) inventory. The HOME-SF includes items grouped into two sub-scales: emotional support and cognitive stimulation. It has four parts: one for children under age three; a second for children between the ages of three and five; a third for children ages six through nine; and a fourth version for children ten and over. The total raw score for the HOME-SF is a simple summation of the recorded individual item scores and it varies by age group, as the number of individual items varies according to the age of the child. At the endline/month 11 survey the HOME scale scores ranged from 0-45, with higher scores denoting better outcomes. | Month 11/Endline survey (Arm 1 with and without fathers, Arm 2 with and without Fathers, Arm 3). | 
| Parenting Practices (HOME Observation for Measurement of the Environment - HOME) | At follow-up surveys, the study will collect the Home Observation for Measurement of the Environment (HOME)- Short Form (SF) inventory. The HOME-SF includes items grouped into two sub-scales: emotional support and cognitive stimulation. It has four parts: one for children under age three; a second for children between the ages of three and five; a third for children ages six through nine; and a fourth version for children ten and over. The total raw score for the HOME-SF is a simple summation of the recorded individual item scores and it varies by age group, as the number of individual items varies according to the age of the child. At the month 35-37/follow-up survey the HOME score ranged 0-55 with higher scores denoting better outcomes. | Month 35-37 Follow-up Survey (Arms 3, A and B). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Height | child length-for-age measured in centimeters. Enumerators measured the child three times and calculated the mean; all measures were converted to length-for-age Z scores following World Health Organization (WHO) recommendations and calculated using Stata version 16's zscore06 command that uses 2006 WHO child growth standards and adjusts for child age and sex. Mean score is 0 for reference population. A score of <-2 SD is considered stunted linear growth. Higher scores represent better outcomes. | Month 11/endline survey. | 
| Changes in Nutritional Practices | Child dietary diversity is measured using a 0-7 scale in which parents report the categories of foods eaten by the child in the past 24 hours following WHO recommendations for child feeding. Higher scores denote better dietary diversity. | Month 11/endline survey (Arms 1, 2 with and without fathers, and Arm 3), and follow-up 2/month 35-37 survey (Arms 3, A and B). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Childhood Development, Parenting Behaviors, Group-based curriculum, Kenya, Child Outcomes, Community Health Volunteers