Understanding your Newborn and Adapting to parenthood (UNA): A randomised clinical effectiveness trial of the Newborn Behavioural Observations (NBO) for new families.

INTERVENTION: In this study, the intervention group (G2), will be offered three NBO sessions coinciding with episodes of routine post‐natal care in the first month of parenthood (in addition to being offered treatment as usual (TAU) in the hospital or in the community for their mental health as required). Standard care may involve regular therapy sessions with a mental health professional and/or medication, depending on the needs of the individual. The intervention will be delivered by a midwife who is an accredited NBO practitioner. Each NBO will be a structured session between clinician and family, consisting of 18 very brief, baby‐led and baby‐responsive, neuro‐behavioural activities and observations, which reveal the infant’s capacities and behavioural adaptation from birth to the third month of life. Each visit for the NBO will take between 30 minutes to 1 hour depending on the baby due to feeding, sleeping etc. Each visit will be timed to coincide with the maternal child health (MCH) home visit when baby is 1‐4 days old, and the 2 week and 4 week MCH clinic or home visit. Adherence to the interventions will be monitored via a home visit registry. Fidelity to the intervention will be monitored by fortnightly supervision by an experienced NBO practitioner which will include reviewing a video recording of the second NBO session for all G2 families with the midwife. The midwife will also complete an NBO fidelity questionnaire at the end of every NBO session provided. CONDITION: Postpartum Depression PRIMARY OUTCOME: 1. Quality of mother‐infant interaction will be assessed using an observational assessment called the Emotional Availability Scales (EAS). This will be a video recorded mother‐infant play session at the home visit endpoint assessment and sent to be blind‐coded by coder who is accredited in using the EAS. 2. Diagnosis of postnatal depression as measured by the Structured Clinicial Interview for the DSM‐5 (MDE module), 3. Infant development assessed using the Bayley Scales of Infant and Toddler Development‐III ; INCLUSION CRITERIA: Women's eligibility will be ascertained in two stages: First during pregnancy where if eligible they will be recruited and screened and then at birth for all follow up after birth even if they have been randomised. The following eligibility criteria include: During Pregnancy: ‐Nulliparous ‐Up to 36 weeks gestation ‐Able to speak English and to respond to a written questionnaire ‐Live within 40 minutes’ drive of the hospital from which they are recruited (RWH, Melbourne or Bendigo, VIC). At Birth: ‐Baby born at term without a severe disability; During pregnancy, male partners will be eligible to participate if they are expectant first time fathers whose female partner has consented to take part in the study, if they are age 20 or more, and if they are able to speak and to respond to a written questionnaire in English. SECONDARY OUTCOME: Acceptability and usefulness of the NBO for parents assessed using a parent feedback questionnaire created for this study Infant Temperament as measured by the Parenting Stress Index PSI adaptability, distractibility and mood subscales Parental attachment as measure by the Parenting Stress Index ‐ attachment subscale Parental reflective functioning as measured by the Prenatal Parental Reflective Functioning Questionnaire and Parental Reflective Functioning Questionnaire Parenting self‐efficacy as measured by the Parental Self‐efficacy Scale Prenatal attachment as measured by the Prenatal Attachment Inventory, PAI Primary Outcome 4: Symptoms of depression as measured by the Edinburgh Postnatal Depression Scale (EPDS) Primary Outcome 5: Parenting stress as measured by the Parenting Stress Scale Psychosocial functioning as measured by the Antenatal Risk Questionnaire and Postnatal Risk Questionnaire Relationship satisfaction as measured by the Relationship Satisfaction Scale