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Clinical trialNCT05532202CompletedInterventional

A Mobile Web-Based Parenting Intervention to Strengthen Social-Emotional Development of Low Birth Weight Infants

SponsorGeorgia State UniversityEnrollment102Infant HealthIntensive Care Units NeonatalParenting
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Low birth weight (LBW) infants are at significantly elevated risk for a host of detrimental outcomes including cognitive, language, and social delays and disabilities, which persist into adulthood. An important protective factor for mitigating risk is sensitive and responsive parenting. While evidence- based home visiting interventions exist and were developed specifically for LBW infants, such as the Play and Learning Strategies program, parents face major obstacles in accessing these interventions. In general, interventions demonstrated to be effective through federal research are very slow to migrate to community service delivery systems. Exacerbating this problem currently is the fact that while VLBW has been increasing, and disproportionately so for those who are poor an of minority status, home visiting programs have sustained some of the largest cuts in their histories. Consequently, there is high demand for effective interventions that can be delivered remotely. Through prior, the investigator team addressed this need by adapting the evidence-based PALS program for web-based delivery using laptop computers with streaming video of in-home parent child interactions and weekly remote coaching. The investigator team then rigorously tested its effects in a sample of low-income mothers and infants with typical birth histories. Results of this randomized controlled study showed pre-post growth in maternal sensitivity behaviors and significant increases in infants' social engagement with their mothers, with moderate to large effect sizes for the intervention group as compared to the control group. These encouraging results provide a strong empirical basis for the enhanced web-based delivery method of the PALS program. Although PALS was originally developed and tested with LBW infants, the web-based version, InfantNet, has not yet been tested with this population. Moreover, emergent trends show that young Latino and Black women most often access the Internet through smart phones, not laptops. Consequently, there is great demand for improving access to evidence-based interventions by making them available on mobile devices such as smart phones. Response: To address the need for more accessible evidence-based interventions, the investigator team will overlay the InfantNet program onto the iPhone and rigorously test its effects with 60 low- income mothers and their LBW infants through a 2-arm, 3 cohort, randomized-controlled design.

Investigators

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Sites

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Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
11 Feb 2015
Primary completion
16 Jun 2017
Completion
16 Jun 2017
Last update posted
21 Sept 2022
Registered enrollment
102
Registry id
NCT05532202

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.