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

NCT06140017 | Active Not Recruiting

• 1 other identifier: R01HD107116
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Child Development; Child Behavior; Language, Child

Outcome Measures

Primary Outcomes (1)

• Child Cognitive Development - Bayley

  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.

  Midline/8-month survey, Endline/24-month survey

Secondary Outcomes (1)

• Parenting Behaviors

  Midline/8-month survey, Endline/24-month survey

Other Outcomes (1)

• Maternal Depression

  Midline/8-month survey, Endline/24-month survey

Study Arms (3)

In-Person Group Delivery

ACTIVE COMPARATOR

A total of 30 villages will receive a traditional in-person group-based delivery for Msingi Bora, 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

Hybrid mHealth/In-Person Group Delivery

EXPERIMENTAL

30 CHVs will deliver a hybrid intervention that combines in-person meetings with remote delivery for Msingi Bora, an ECD parenting intervention. 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

Control Group

NO INTERVENTION

Mothers and children in 30 villages will not receive any intervention beyond information about child feeding during a baseline survey.

Interventions

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.

Hybrid mHealth/In-Person Group Delivery; In-Person Group Delivery

Eligibility Criteria

• Age: 4 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Early Childhood Development Network for Kenya (ECDNeK): collaborator
• Safe Water and AIDS Project: collaborator

Study Sites (1)

Safe Water and AIDS Project

Kisumu, 40100, Kenya

Location

Related Publications (2)

• Garcia IL, Luoto J, Aboud F, Jervis P, Mwoma T, Alu E, Odhiambo A. In-person versus remote (mHealth) delivery for a responsive parenting intervention in rural Kenya: a cluster randomized controlled trial. BMC Public Health. 2024 Sep 5;24(1):2421. doi: 10.1186/s12889-024-19828-5.

  PMID: 39237936 DERIVED

• Garcia IL, Luoto J, Aboud F, Jervis P, Mwoma T, Alu E, Odhiambo A. In-person versus remote (mHealth) delivery for a responsive parenting intervention in rural Kenya: A cluster randomized controlled trial. Res Sq [Preprint]. 2024 Aug 16:rs.3.rs-4733054. doi: 10.21203/rs.3.rs-4733054/v1.

  PMID: 39184097 DERIVED

MeSH Terms

Conditions

Child Behavior; Language

Condition Hierarchy (Ancestors)

Behavior; Communication

Study Officials

• Italo Lopez Garcia, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Jill E Luoto, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: October 24, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

KE (1)