Testing Means to Scale Early Childhood Development Interventions in Rural Kenya

Not Applicable

Completed

• Conditions: Early Child Development
• Interventions: Behavioral: Group+Home sessions; Behavioral: Group sessions; Behavioral: Fathers invited; Behavioral: Booster sessions

• Registration Number: NCT03548558
• Lead Sponsor: University of Southern California

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-07
• Study Start: 2018-10-01
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15
• Results First Submitted: 2023-05-16
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Results First Posted: 2023-10-13
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1152

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm 2 ("group+home" sessions)	Group+Home sessions	Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits)
Arm B (Booster villages)	Group sessions	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
Arm Y: Fathers not invited	Group sessions	During phase 1, fathers were not invited in the other half of Arms 1 and 2 villages.
Arm 1 ("group" sessions)	Group sessions	Group meetings only (16 total)
Arm X: Fathers invited	Group+Home sessions	During phase 1, fathers were invited to attend sessions in half of Arms 1 and 2 villages.
Arm X: Fathers invited	Fathers invited	During phase 1, fathers were invited to attend sessions in half of Arms 1 and 2 villages.
Arm Y: Fathers not invited	Group+Home sessions	During phase 1, fathers were not invited in the other half of Arms 1 and 2 villages.
Arm B (Booster villages)	Group+Home sessions	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
Arm B (Booster villages)	Booster sessions	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
Arm A (Non-booster villages)	Group sessions	In the other half of Arm 1 and Arm 2 villages, no boosters will be held during phase 2
Arm X: Fathers invited	Group sessions	During phase 1, fathers were invited to attend sessions in half of Arms 1 and 2 villages.
Arm A (Non-booster villages)	Group+Home sessions	In the other half of Arm 1 and Arm 2 villages, no boosters will be held during phase 2

Primary Outcome Measures

Name	Time	Method
Child Developmental Outcomes	Month 35-37/Follow-Up survey (Arms 3, A and B), two years after end of Phase 1's 16 biweekly sessions	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.
Parenting Practices (HOME Observation for Measurement of the Environment - HOME)	Month 35-37 Follow-up Survey (Arms 3, A and B).	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Nutritional Practices	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).	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.
Child Height	Month 11/endline survey.	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.

Trial Locations

Locations (1)

USC; 🇺🇸 Los Angeles, California, United States