An interventional study of Msingi Bora responsive parenting and family wellbeing program in Child Development, Child Behavior and Language, Child, sponsored by University of Southern California. Active, not recruiting at 1 site in Kenya. Open to participants aged 4 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by University of Southern California · Not applicable, Interventional, and Prevention
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.
224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 140 across 197 interventional studies indexed under Child Behavior.
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Exclusion Criteria:
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
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
Mothers and children in 30 villages will not receive any intervention beyond information about child feeding during a baseline survey.
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.
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.
Time frame: Midline/8-month survey, Endline/24-month survey
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.
Time frame: Midline/8-month survey, Endline/24-month survey
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.
Time frame: Midline/8-month survey, Endline/24-month survey
Plan to share: Yes — The final dataset will be stripped of identifiers prior to release for sharing. In no way will there be the possibility of deductive disclosure of subjects. We will make the data without identifiers publicly available in accordance with NIH policy by posting it in de-identified form to the Inter-university Consortium for Political and Social Research (ICPSR) data bank. More information on their data confidentiality practices can be found at: https://www.icpsr.umich.edu/web/pages/datamanagement/confidentiality/index.html.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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