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

NCT05532202 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2022-09-21

No results posted yet for this study

Summary

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.

Conditions

  • Intensive Care Units Neonatal
  • Parenting
  • Infant Health

Interventions

BEHAVIORAL

NICU Mom and Baby Net

See arm descriptions.

OTHER

NICU Developmental Awareness System

See arm description.

Sponsors & Collaborators

  • Health Resources and Services Administration (HRSA)

    collaborator FED
  • Georgia State University

    lead OTHER

Principal Investigators

  • Kathleen M Baggett, PhD · Georgia State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-11
Primary Completion
2017-06-16
Completion
2017-06-16

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532202 on ClinicalTrials.gov