Effectiveness of a psycho-educational intervention to prevent postpartum parental distress and enhance infant well-being: study protocol of a randomized controlled trial.

BACKGROUND: The first months after birth can be challenging for parents, leading to parental distress and decreased well-being. Parents with high levels of distress are found to respond less adequately and sensitively to their infant, which in turn affects infant well-being and health. The goal of this study is to examine the effectiveness of a psycho-educational intervention to prevent postpartum parental distress and enhance the quality of caregiving and infant well-being. In contrast to other interventions, this intervention will be (1) offered already before birth, (2) offered to all parents-to-be, regardless of their risk of postpartum distress, and (3) include fathers. The proposed study examines the effectiveness of this intervention on (1) parenting distress, (2) quality of caregiving, and (3) the infant's well-being.

METHODS/DESIGN: In this randomized controlled trial, 128 pregnant women and their partners will be recruited through midwifery practices and general media. Women with a complicated pregnancy, current psychopathology, insufficient Dutch language proficiency and without Internet access will be excluded. Parents will be randomized to either the intervention or a waitlist control group. The intervention consists of a booklet and video (offered prenatally), a home visit at 34-36 weeks of pregnancy and a telephone call 4 weeks after birth. Information and practical tools are provided on (1) sensitive responding and making contact with the baby, (2) crying, (3) feeding, and (4) sleeping. Assessments will take place at baseline (26-34 weeks of pregnancy), during the home visit (34-36 weeks of pregnancy), and 2, 6, and 10 weeks after birth. The control group will be offered the intervention after the end of the study. The primary outcome is maternal parenting stress. Secondary outcomes are: paternal parenting stress, parental well-being, quality of caregiving, and infant well-being and health.

DISCUSSION: The goal of this study is to test the effects of a psycho-educational prenatal parenting intervention to prevent postpartum parental distress and to enhance well-being in both parents and infants. When the intervention appears effective it can be implemented broadly because of its low costs. It will make support available for a large number of parents and their children.

TRIAL REGISTRATION: Netherlands National Trial Register, ID: NTR6065 . Registered on 15 September 2016.