Abstract
BACKGROUND/OBJECTIVES: Parents of premature infants experience depression, anxiety, post-traumatic stress disorder, and increased stress, which can negatively impact parent-infant relationships and infant development. To reduce negative consequences and optimally support families, we developed the Transition to Home model (TtH). In this randomized controlled pilot trial (RCT), the feasibility of performing an experimental study to analyse the effects of TtH on parental mental health over time was evaluated. METHODS: The following domains were assessed: recruitment, follow-up and study burden, outcome measures used and parental mental health outcomes. We included n = 22 parent couples with their preterm infants in the control group and n = 23 in the intervention group. Depression, anxiety and post-traumatic stress disorders, parenting stress, and parental self-efficacy were assessed at five timepoints. The study burden was evaluated once at the end of the study. RESULTS: The control and intervention groups had similar socio-demographic characteristics. The groups showed no differences in the mental health outcomes except for depression in mothers at T2 (p = 0.042) and T5 (p = 0.027) and state anxiety in fathers at T2 (p = 0.016). CONCLUSIONS: This pilot RCT established a framework for the evaluation of the TtH model of care and demonstrated the viability of the evaluation scheme. The results confirm the suitability of the RCT's structure and the feasibility of the methods and instruments used. Minor adjustments are recommended to include a more diverse sample in future studies.