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Testing Means to Scale Early Childhood Development Interventions in Rural Kenya

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University of Southern California

Status

Completed

Conditions

Early Child Development

Treatments

Behavioral: Booster sessions
Behavioral: Group sessions
Behavioral: Fathers invited
Behavioral: Group+Home sessions

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03548558
1R01HD090045
R01HD090045 (U.S. NIH Grant/Contract)
R21HD098508 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,152 patients

Sex

All

Ages

15+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

1,152 participants in 7 patient groups

Arm 1 ("group" sessions)
Experimental group
Description:
Group meetings only (16 total)
Treatment:
Behavioral: Group sessions
Arm 2 ("group+home" sessions)
Experimental group
Description:
Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits)
Treatment:
Behavioral: Group+Home sessions
Arm 3
No Intervention group
Description:
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
Arm B (Booster villages)
Experimental group
Description:
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
Treatment:
Behavioral: Group+Home sessions
Behavioral: Booster sessions
Behavioral: Group sessions
Arm A (Non-booster villages)
Other group
Description:
In the other half of Arm 1 and Arm 2 villages, no boosters will be held during phase 2
Treatment:
Behavioral: Group+Home sessions
Behavioral: Group sessions
Arm X: Fathers invited
Experimental group
Description:
During phase 1, fathers were invited to attend sessions in half of Arms 1 and 2 villages.
Treatment:
Behavioral: Fathers invited
Behavioral: Group+Home sessions
Behavioral: Group sessions
Arm Y: Fathers not invited
Other group
Description:
During phase 1, fathers were not invited in the other half of Arms 1 and 2 villages.
Treatment:
Behavioral: Group+Home sessions
Behavioral: Group sessions

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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