A Randomized Control Trial of a Scalable Parenting Program to support Candidate Brain Pathways, Autonomic Regulation, and Socio-Emotional Development in Preterm Infants

About This Grant

Project Summary/Abstract In the US, more than one out of every ten babies are born prematurely (before < 37 weeks of gestation) each year, accounting for 10-11% of live births.1 Globally, an estimated 15 million babies are born preterm each year, which is likely underestimated, given difficulties with tracking in low- and middle-income countries.2 Medical breakthroughs before the turn of the century dramatically increased survival of babies born at earliest stages.3 The field now faces increased prevalence rates of mental health disorders among adult survivors of preterm birth,6,7 which comes at great cost to individuals, families, and society. Annually, the US spends over $26 billion dollars in direct and indirect costs related to preterm birth.8,9 This reality underscores the need for investment in services that can better promote long-term mental health of this growing population. Early parenting interventions are among the most promising and cost-effective solutions to support long term mental health and well-being. Few programs deliver services starting in early infancy shortly after hospital discharge– or use scalable approaches that can engage multiple parents. Efforts that better engage fathers are especially needed. Fathers are severely underserved for their own needs and are underrecognized as critical supporters for mother and infant well-being. Developmental studies indicate that brain dysmaturation in frontal-limbic pathways is a secondary consequence of preterm birth and may contribute to long term sequalae. Programs that show positive effects on both behavioral and neurodevelopmental levels may be essential for supporting lasting change in infants, which motivates hypotheses in our study. Our objective is to test the effectiveness of a web-based, scalable parenting program, Play and Learning Strategies (ePALS), for parents and prematurely born infants, to improve parental responsiveness, promote early childhood mental health, and examine mechanisms of effectiveness through changes in neurodevelopmental pathways. Parents of infants born preterm (between 3-9 months of age, corrected for prematurity) will be randomly assigned to our target intervention, ePALS versus an active control program of the same duration and format. We will use an innovative, multimodal approach to examine behavioral pathways (socio-emotional and emotion regulation) and associated neurodevelopmental substrates, using EEG electroencephalography/event related potentials (EEG/ERPs), structural and functional magnetic resonance imaging (sMRI, rsfMRI), diffusion tensor imaging (DTI), and autonomic nervous system (ANS) recordings. Aim 1 will test whether participation in infant ePALS improves parental responsiveness in the first years of their infants’ life. Aim 2 will test the effects of ePALS on reducing risk for poor emotion regulation based on 2A) behavioral outcomes (parent report and standardized assessments), 2B) neurophysiological processes (EEG, ERP, ANS) and 2C) and frontal-limbic brain pathways (structural, functional, MRI, DTI). Aim 3 will examine mediators and moderators, to understand mechanism of change driving intervention related improvements in parenting and child outcomes.