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There is one clinical trial.
The purpose of this study is to compare the mother-infant emotional connection formed during the pandemic in standard care (SC) versus Family Nurture Intervention (FNI) pairs, an evidence-based intervention designed to counteract the adverse effects of maternal-infant disconnection. In prior research on preterm infants in the neonatal intensive care unit (NICU), FNI participants demonstrated increased quality of maternal caregiving behaviors and significant improvements in premature infants' neurodevelopment across multiple domains, including social-relatedness and attention problems. Goals of FNI include assisting mothers in providing appropriate types of stimulation for their babies that are important for social, emotional, and neurobehavioral development as well as reducing stress physiology in both mother and infant. Data gathered in this study will help the investigators learn more about the underlying mechanisms that take place during mother-infant interactions and examine how these play a role in setting the infant up for the best neurodevelopmental trajectory. Intervention will be conducted electronically both in the Well Baby Nursery (WBN) and at home over the following 4 months. Assessments will consist of videos of mother-infant interactions at the time of each intervention session, and pediatrician-led follow-up surveys conducted in the linked Institutional Review Board-approved study.
Description: The Welch Emotional Connection Screen (WECS) is a validated scale for quantitative assessment of the emotional connection between infant and mother by scoring the interaction of the dyad in four domains: attraction, vocal communication, facial communication, and sensitivity/reciprocity. The domains are scored on a scale from 1.0 to 3.0 in 0.25 point increments, with higher scores indicating stronger emotional connection. In combination with the rating of the four domains, the overall WECS score is classified as "emotionally connected" or "not emotionally connected." A score of "emotionally connected" or "not emotionally connected" is determined by the observers' overall assessment of the emotional connection of the dyad. The WECS will be measured at baseline for both groups, and at each of the 3 subsequent visits by a researcher observing the dyadic interaction during a 5 minute period of face-to-face time. Changes in score from baseline to 3 months will be evaluated for FNI groups.
Measure: Change in Welch Emotional Connection Score Time: Baseline, 1 month, 2 months, 3 monthsDescription: The quality of caregiving in the domain of acceptance versus rejection, will be measured on a scale from 1-9, with 9 indicating higher quality caregiving. During each Zoom call, following the mother-infant interaction video but prior to intervention for the FNI group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior with measures such as sensitivity and intrusiveness.
Measure: Change in Maternal Caregiving Behavior Score (Acceptance versus Rejection) Time: Baseline, 1 month, 2 months, 3 monthsDescription: The quality of caregiving in the domain of sensitivity versus insensitivity, will be measured on a scale from 1-9, with 9 indicating higher quality caregiving. During each Zoom call, following the mother-infant interaction video but prior to intervention for the FNI group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior with measures such as sensitivity and intrusiveness.
Measure: Change in Maternal Caregiving Behavior Score (Sensitivity versus Insensitivity) Time: Baseline, 1 month, 2 months, 3 monthsDescription: The quality of caregiving in the domain of consideration versus intrusiveness, will be measured on a scale from 1-9, with 9 indicating higher quality caregiving. During each Zoom call, following the mother-infant interaction video but prior to intervention for the FNI group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior with measures such as sensitivity and intrusiveness.
Measure: Change in Maternal Caregiving Behavior Score (Consideration versus Intrusiveness) Time: Baseline, 1 month, 2 months, 3 monthsDescription: The quality of caregiving in the domain of quality of physical contact, will be measured on a scale from 1-9, with 9 indicating higher quality caregiving. During each Zoom call, following the mother-infant interaction video but prior to intervention for the FNI group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior with measures such as sensitivity and intrusiveness.
Measure: Change in Maternal Caregiving Behavior Score (Quality of Physical Contact) Time: Baseline, 1 month, 2 months, 3 monthsDescription: The quality of caregiving in the domain of quality of vocal contact, will be measured on a scale from 1-9, with 9 indicating higher quality caregiving. During each Zoom call, following the mother-infant interaction video but prior to intervention for the FNI group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior with measures such as sensitivity and intrusiveness.
Measure: Change in Maternal Caregiving Behavior Score (Quality of Vocal Contact) Time: Baseline, 1 month, 2 months, 3 monthsDescription: The quality of caregiving in the domain of effectiveness of response to baby's crying, will be measured on a scale from 1-9, with 9 indicating higher quality caregiving. During each Zoom call, following the mother-infant interaction video but prior to intervention for the FNI group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior with measures such as sensitivity and intrusiveness.
Measure: Change in Maternal Caregiving Behavior Score (Effectiveness of Response to Baby's Crying) Time: Baseline, 1 month, 2 months, 3 monthsDescription: 2 Epilog devices will be put on mother and baby's foreheads for 2 lead EEG recording, left frontal and right frontal. EEG synchrony between mom and baby will be examined for change in synchrony over the course of the first intervention in the nursery.
Measure: Right and Left Frontal Mother & Infant EEG Synchrony Time: Baseline, Up to 3 daysDescription: Epilog devices will be used to collect ECG from both mother and infant during the first interaction and intervention in the nursery. Change in synchrony of HRV will be examined over the course of the intervention.
Measure: Heart Rate Variability (HRV) Time: Baseline, Up to 3 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports