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

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06140017
• Other study ID #: R01HD107116
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2023
• Est. completion date: December 15, 2025

Study information

• Verified date: February 2024
• Source: University of Southern California
• Contact: Italo Lopez Garcia, PhD
• Phone: 12137641564
• Email: italolop[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior
• Child Development
• Language, Child

Intervention

Behavioral:
• Msingi Bora responsive parenting and family wellbeing program
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.

Locations

Country	Name	City	State
Kenya	Safe Water and AIDS Project	Kisumu

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	Early Childhood Development Network for Kenya (ECDNeK), Safe Water and AIDS Project (SWAP)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal Depression	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.	Midline/8-month survey, Endline/24-month survey
Primary	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	Parenting Behaviors	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.	Midline/8-month survey, Endline/24-month survey