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NCT Number: NCT06140017

Achieving Sustained Early Child Development Impacts at Scale: A Test in Kenya

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. Study investigators 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 a 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 rural Kenya, particularly if interventions are needed that can be extended for longer periods of time to increase their ability to sustain impacts. This study will experimentally test a traditional in-person group-based delivery model for an ECD parenting intervention against an mHealth-based delivery model that partially substitutes remote delivery for in-person group meetings. The relative effectiveness and costs of this hybrid-delivery model will be assessed against a purely in-person group model, and the interventions will extend over two years to increase their ability to sustain changes in child outcomes longer-term. The evaluation design is a clustered Randomized Control Trial across 90 CHWs and their associated villages and 1200 households. The central hypothesis is 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

4 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Safe Water and AIDS Project

Kisumu, 40100, Kenya

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mothers or other primary caretakers aged 18 years or older
  • able to read English or Swahili at a level sufficient to understand the SMS messages
  • with a child aged 6-18 months at recruitment without signs of severe mental or physical impairments (youngest child if more than one eligible for a given mother)

Exclusion criteria

  • mothers/households without children
  • households with children that are outside the age range of 6-18 months at baseline
  • mothers who lack basic literacy so as not to understand SMS messages

Treatment and study plan

Msingi Bora responsive parenting and family wellbeing program

Behavioral

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.

Primary outcomes

  1. Child Cognitive Development - Bayley

    Time frame: Midline/8-month survey, Endline/24-month survey

    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 scale has a 0-19 range with higher values denoting better scores.

Secondary outcomes

  1. Parenting Behaviors

    Time frame: Midline/8-month survey, Endline/24-month survey

    The Home Observation for Measurement of the Environment (HOME)- Short Form (SF) inventory has four versions: 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 8 survey the HOME scale scores will range from 0-45, with higher scores denoting better outcomes.

Other outcomes

  1. Maternal Depression

    Time frame: Midline/8-month survey, Endline/24-month survey

    The Patient Health Questionnaire (PHQ-8) is a self-reported measure of depressive symptoms during the previous two weeks. It is composed of 8 Likert-style items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day). The PHQ-8 final score ranges from 0 to 24, with higher scores corresponding to higher levels of depression.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Safe Water and AIDS Project

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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