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The aim of this study is two-fold: 1) To study risk factors for the development of postpartum depression, including cognitive factors (i.e., perseverative negative thinking and interpretation of infant facial expressions), and other factors such as negative childhood experiences, parental attachment, parental stress and previous psychopathology. 2) Investigate the effect of The Newborn Behavioral Observation (NBO) as a universal prevention intervention implemented at well-baby clinics in Tromsø with regard to parental mental health, parent-infant interaction and child development.
This is a longitudinal observational study with an intervention. The observational part of the study will use a prospective cohort design. To compare an intervention group receiving The Newborn Behavioral Observation (NBO) with a control group receiving standard health care the investigators will use a non-randomized cluster controlled design, since neither cluster randomization, nor randomization at the individual level is feasible in the routine practice setting. Parents with infants belonging to two well-baby clinics in Tromsø, Norway will be offered the NBO intervention. Parents and infants belonging to the rest of the well-baby clinics in the municipality of Tromsø will receive standard health care, i.e. treatment as usual and constitute the control group.
Participants will be recruited by midwifes at the Midwife Center and by general practitioners (GPs) in the municipality of Tromsø. Midwifes and GPs will be informed of the project by the research group. The participants will be recruited in (approximately) week 16 of gestation, when they have their first visit at the Midwife Center, or earlier in their first trimester by their GP. At recruitment the parents will be informed that most of them will receive standard health care after delivery, and that some will be given a new consultations method for public health nurses. All pregnant women and expecting fathers who speak Norwegian are eligible for inclusion in the study.
Based on the experiences from a comparable study, "Little in Norway", the investigators expect that about 25 % of all pregnant women (and expecting fathers) in the municipality of Tromsø will participate in the specified time period, i.e. about 500 families in total.
For the observational part of the study, assessments will be performed at five time points: The first assessment is at week 16 - 22 of gestation, the second at week 24 - 30 of gestation, the third at about week 31 of gestation, the fourth 6 weeks post-delivery and the fifth 4 months post-delivery. For the intervention study pre-intervention measures will take place at about week 31 of gestation, post-intervention measures at 6 weeks post-delivery and follow-up measures at 4 months and 6 months post-delivery. In addition, parents will be asked to fill out a questionnaire regarding their experiences with the intervention after each of the three NBO consultations. Also, after each of the NBO consultations, the health worker conducting the intervention fills out a form about their judgment of the infant along four dimensions: autonomic, motor, state organization and attentional-interactional.
The data will be collected on questionnaires administered over the Internet. The researcher will contact the parents and ask them to complete the measures over the Internet. The exception is the NBO questionnaires mentioned above which will be completed in conjunction with the NBO consultations, and The Edinburgh Postnatal Depression Scale (EPDS) at 6 weeks post-delivery which will be collected by the public health nurse using the paper-and- pencil version at the well- baby clinic as a part of routine practice. Also the researcher will meet the families at week 16 of gestation for inclusion, 6 weeks and 4 and 6 months post-delivery.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
The Newborn Behavioral Observation (NBO), Routine care
Not yet recruiting
University of Tromso
Published on BioPortfolio: 2015-09-03T00:23:23-0400
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