What are the effects of supporting early parenting by enhancing parents' understanding of the infant? Study protocol for a cluster-randomized community-based trial of the Newborn Behavioral Observation (NBO) method

Background: Support to strengthen the early parent-infant relationship is recommended to ensure the infant's future health and development. Little is known about the universal approaches taken by health visitor to support this early relationship. The aim of this study is to investigate the effects of health visitors' use of the Newborn Behavioral Observation (NBO) method among new parents. Methods: This is a cluster-randomised community-based study implemented in four Danish municipalities. Health visitors will conduct the trial, and the geographical districts they work in will constitute the clusters as units of randomisation. The participants will be approximately 2800 new families, randomised into an intervention or a comparison group according to their health visitor. The families are recruited at the first postpartum home visit. Parents in both groups receive care as usual: parents in the intervention group also receive the standardised NBO method in home visits performed from 3 weeks to 3 months postpartum. Data consist of self-reported parent questionnaires and video recordings of a selected group of vulnerable first-time mothers recorded 4 months postpartum. The self-reported data are obtained: at baseline 1 week postpartum and then at follow-up 3, 9 and 18 months postpartum. Data will be analysed using the intention-to-treat method and the analyses will include comparison of change in the primary variables across time supplemented by multiple regression analysis. The primary study outcomes are measured by the following factors: parental confidence, infants' socio-emotional development and mother-infant relationship. Other measures include parental mood and stress, breastfeeding duration and utility of the health visitor services. Data collection among the health visitors in both groups will serve to monitor any change in practice regarding the work with early parent-infant interactions. Discussion: This protocol describes an evaluation of the NBO method used universally in health visiting practice. The intervention seeks to support early parenting by increasing parents' understanding of their infants' cues. The NBO is currently implemented in Denmark even though an evaluation of the NBO has yet to be made in a community setting in Denmark and internationally. The study may contribute to building an increasingly evidence-based practice for health visitors.