Clinical Trials Logo

Clinical Trial Summary

Maternal sensitivity and contingent responsiveness to infant behavioral cues is an important contributor to infants' developing capacities to self-regulate. During early infancy, feeding interactions comprise a significant portion of mother-infant dyadic interactions and high-quality feeding interactions provide both nutritive and socioemotional benefits; recent data suggest that, for many dyads, mothers' sensitive responsiveness during feeding interactions is routinely impacted by the omnipresence of portable technology. The objective of the proposed research is to better understand the development and possible impacts of maternal technology use on infant feeding interactions, emotion and intake regulation, and sociobehavioral and growth outcomes.


Clinical Trial Description

The development of effective self-regulation is one of the most important achievements of early childhood and is associated with better stress reactivity, lower risk for internalizing and externalizing problems, and lower risk for obesity. During infancy, key interconnected domains of self-regulation include emotion (i.e., distress regulation) and feeding (i.e., caloric intake regulation). An important contributor to regulation across these domains is synchrony in caregiver-infant interactions, of which a critical component is caregiver sensitive responsiveness to infant cues. Feeding interactions comprise a majority of early interactions and high quality, synchronous feeding interactions provide the infant with both nutritive and socioemotional benefits. Given recent increases in portable technology use over the past decade, as well as further increases due to social distancing in response to the COVID-19 pandemic, there is growing concern that the omnipresence of technology impacts the nature and quality of family interactions. The PI's previous research illustrates 92% of mothers reported engaging with technological distractors (e.g., watching TV, using mobile devices) during infant feeding and distracted mothers exhibited lower sensitivity than mothers who were not distracted. Short-term experimental studies illustrate maternal technology use reduces the quality of dyadic interaction by decreasing maternal engagement, reducing maternal responsiveness to infants' attention bids, and evoking undesirable infant responses, including increased negative affect and poorer focus. These findings are concerning, but the field is critically limited by a lack of longitudinal data to inform whether these short-term impacts are indicative of long-term detriments to infant development. The present study is a novel longitudinal study featuring within-subject experimental manipulations and intensive assessments to better understand how maternal technology use impacts infant socioemotional, feeding, and growth outcomes. 345 women will be recruited during the 3rd trimester of pregnancy, then will be assessed 1, 4, 6, 9, and 12 months postpartum. The following aims will be addressed: Aim 1: Examine impacts of maternal technology use on early feeding interactions and change in these impacts across early infancy. At 1 month and 4 months, dyadic interactions will be observed during 3 counterbalanced within-subject experimental feeding conditions: 1) Control: mothers will not engage with TV or mobile devices; 2) TV Use: mothers will watch a TV show; 3) Mobile Device Use: mothers will use a mobile device. Videos of these interactions will be coded to obtain a comprehensive understanding of whether and how maternal technology use influences dyadic interactions, as well as potential bidirectional associations between maternal and infant behavioral responses. Experimental data will be combined with longitudinal data on habitual maternal technology use (see Aim 3) to understand: a) effects of experimentally-manipulated technology use on maternal attention, sensitivity to infant cues, and engagement of the infant, and on infant clarity of cues, attentional responsiveness to the mother, and intake; b) stability vs. change in these effects between 1mo and 4mo; c) moderating effects of habitual maternal technology use (assessed via passive sensing at 1mo and 4mo) on stability vs. change in behavioral responses to experimentally manipulated technology use. Aim 2: Test the hypothesis that greater habitual maternal technology use predicts poorer infant emotion and intake regulation when infants are 6 and 12 months, and greater weight gain from birth-12 months. Infant emotion and intake regulation, and related socioemotional and behavioral problems, will be assessed through established behavioral protocols and maternal report via validated questionnaires. Longitudinal associations between habitual maternal technology use and infant outcomes will be examined, as well as potential mediating or moderating effects of maternal sensitive responsiveness (objectively assessed via naturalistic feeding and play observations) or feeding mode (breast- vs. bottle-feeding), respectively. Aim 3: Describe levels of and changes in habitual maternal technology use between the prenatal and postpartum periods and examine predictors of habitual technology use patterns. Passive sensing (via an app) of maternal technology use will be integrated with time diaries to describe total daily technology use and use during infant feeding interactions at each assessment. Hypothesized predictors of habitual technology use include maternal depressive symptoms, stress, emotion regulation, feeding styles, and reflective functioning. The investigators will also examine whether habitual maternal technology use is predicted by infant characteristics, including infant behavioral responses to experimentally manipulated technology use, sex as a biological variable, eating behaviors, and temperament. The proposed research will employ innovative approaches to answer questions relevant to today's technology-focused society. Findings will provide a foundation for the development of targeted interventions that strengthen mothers' abilities: 1) to be sensitive and attentive to their children in the presence of distracting technology and 2) effectively integrate technology use into family contexts in ways that preserve benefits and minimize risks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05781100
Study type Interventional
Source California Polytechnic State University-San Luis Obispo
Contact Alison K Ventura, PhD
Phone (805) 756-5693
Email akventur@calpoly.edu
Status Recruiting
Phase N/A
Start date January 16, 2023
Completion date June 30, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT05793112 - INF108F in Infants With Food Protein Induced Proctocolitis Phase 4
Recruiting NCT03828708 - Early Iron Exposure on the Gut Microbiota in Young Infants N/A
Recruiting NCT06018064 - Investigating Fit and Satisfaction of the Prone Positioner N/A
Not yet recruiting NCT06335524 - Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants N/A
Not yet recruiting NCT05039918 - Neonatal Experience of Social Touch N/A
Completed NCT01166867 - A Pilot Study Using Photo-plethysmographic (PPG) Camera
Completed NCT00791466 - Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development N/A
Completed NCT03331276 - Growth and Safety Study of an Infant Formula for Healthy Term Infants N/A
Completed NCT05157633 - Oral Exploration of Objects and Food Diversification
Completed NCT05217186 - Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
Recruiting NCT05006989 - Blueberry Intake and Infant Gut Health N/A
Completed NCT04901611 - Parental Touch Trial (Petal) N/A
Completed NCT03082313 - Movement-based Infant Intervention N/A
Recruiting NCT06053515 - Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication N/A
Completed NCT05394883 - The SPROUT (Pilot) Project N/A
Completed NCT03991949 - Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula N/A
Active, not recruiting NCT03851120 - Brain Probiotic and LC-PUFA Intervention for Optimum Early Life Phase 2
Completed NCT03662048 - Improving Infant Sleep Safety With the Electronic Health Record N/A
Active, not recruiting NCT04749888 - Impact of the Korea Early Childhood Home-visiting Intervention N/A
Recruiting NCT06230848 - Multisensory Early Oral Administration of Human Milk in Preterm Infants N/A