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Language, Child clinical trials

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NCT ID: NCT06140017 Recruiting - Child Development Clinical Trials

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

Start date: October 24, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04692519 Recruiting - Clinical trials for Language Development

Duet 2.0 Starting the Conversation: A New Intervention Model to Stimulate Language Growth in Underserved Populations

Start date: December 18, 2020
Phase: N/A
Study type: Interventional

Caregiver-child language interactions in the first three years of life predict early language development, school readiness, and academic achievement. Despite the importance of these factors, there are disparities in the frequency and quality of children's early language interactions. Although there is within-group variability, children from low-income families, on average, have fewer and lower-quality language experiences than their middle- or high-income peers. The current study addresses a need in the community for an early language intervention accessible to low-income families who speak Spanish. This study will build upon research conducted in a previous study, "Enhancing the Communication Foundation-The Duet Project", by piloting the English and Spanish modules with families through a light-touch, remote intervention delivery model. Temple University Health System's Department of Pediatrics will aid in identifying participants. Baseline and follow-up measures will be used to evaluate caregiver knowledge of child development, psychosocial perceptions, demographics, caregiver-child language interaction quality, and child language skills. It is hypothesized that dyads who receive the intervention will make greater gains in early interaction quality, knowledge of child development, and child language skills than the delayed-access control group. This work has the potential to shape early intervention design and implementation for people in underserved communities across the country.