Abstract
BACKGROUND: Parents of preterm infants in the Neonatal Intensive Care Unit (NICU) environment may experience psychological distress, decreased perceived self-efficacy, and/or difficulties in establishing an adaptive parent-infant relationship. Early developmental care interventions to support the parental role and infant development are essential and their impact can be assessed by an improvement of parental self-efficacy perception. The aims were to assess the effects of an early intervention provided in the NICU (the Joint Observation) on maternal perceived self-efficacy compared to controls (primary outcome) and to compare maternal mental health measures (perceived stress, anxiety, and depression), perception of the parent-infant relationship, and maternal responsiveness (secondary outcomes). METHODS: This study was a monocentric randomized controlled trial registered in clinicatrials.gov (NCT02736136), which aimed at testing a behavioural intervention compared with treatment-as-usual. Mothers of preterm neonates born 28 to 32 6/7 weeks gestation were randomly allocated to either the intervention or the control groups. Outcome measures consisted of self-report questionnaires completed by the mothers at 1 and 6 months after enrollment and assessing perceived self-efficacy, mental health, perception of the parent-infant relationship and responsiveness, as well as satisfaction with the intervention. RESULTS: No statistically significant group effects were observed for perceived maternal self-efficacy or the secondary outcomes. Over time, perceived maternal self-efficacy increased for mothers in both groups, while anxiety and depression symptoms decreased. High satisfaction with the intervention was reported. CONCLUSIONS: The joint observation was not associated with improved perceived maternal self-efficacy or other mental health outcomes, but may constitute an additional supportive measure offered to parents in a vulnerable situation during the NICU stay.