Clinical Trial: Northern Babies: A Study of Predictors of Postpartum Depression and Parent-infant Interaction Difficulties

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Predicting Postpartum Depression and Improving Parent-infant Interaction During the Perinatal Period: The Newborn Behavioral Observation Intervention

Brief Summary: 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.

Detailed Summary:

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 wi
Sponsor: University of Tromso

Current Primary Outcome: Levels of postpartum depression [ Time Frame: Six weeks postpartum ]

Mothers and fathers self-reported levels of postpartum depression measured with the Edinburgh Postnatal Depression Scale.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Levels of postpartum depression [ Time Frame: Four months postpartum ]
    Mothers and fathers self-reported levels of postpartum depression measured with the Edinburgh Postnatal Depression Scale.
  • Levels of postpartum depression [ Time Frame: Six months postpartum ]
    Mothers and fathers self-reported levels of postpartum depression measured with the Edinburgh Postnatal Depression Scale.
  • Parental reflective functioning [ Time Frame: Six weeks postpartum ]
    Mothers and fathers self-reported parental reflective functioning measured with the Parental Reflective Functioning Questionnaire.
  • Parental reflective functioning [ Time Frame: Four months postpartum ]
    Mothers and fathers self-reported parental reflective functioning measured with the Parental Reflective Functioning Questionnaire.
  • Attachment between parent and child [ Time Frame: Six weeks postpartum ]
    Self-reported quality of attachment between parent and child measured with Maternal Postnatal Attachment Scale/Paternal Postnatal Attachment Scale.
  • Attachment between parent and child [ Time Frame: Four months postpartum ]
    Self-reported quality of attachment between parent and child measured with Maternal Postnatal Attachment Scale/Paternal Postnatal Attachment Scale.
  • Parent-child interaction [ Time Frame: Four months postpartum ]
    Parent-child interaction will be rated on the basis of 15-30 minutes videotaped episodes of parent-infant play interaction.
  • Parental stress [ Time Frame: Six weeks postpartum ]
    Self-reported measure of parental stress.
  • Parental stress [ Time Frame: Four months postpartum ]
    Self-reported measure of parental stress.
  • A composite measure of the infant´s temperament [ Time Frame: Six months postpartum ]
    Parents report of infant´s sensitivity, general activity, frustration tolerance, adaptability, regularity, and soothability.
  • Infants social withdrawal behaviour [ Time Frame: Six months postpartum ]
    Assessment of the infants social withdrawal behaviour with The Alarm Distress Baby Scale.


Original Secondary Outcome: Same as current

Information By: University of Tromso

Dates:
Date Received: August 4, 2015
Date Started: August 2015
Date Completion: April 2018
Last Updated: May 12, 2016
Last Verified: May 2016