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Updated: Jan 17, 2026
A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
Protocol for the SUPPORTED study: a Danish multicentre complex intervention for first-time fathers of preterm infants
Kristina Garne Holm1,2, Mai-Britt Hägi-Pedersen3,4, Helle Haslund-Thomsen5,6,7
1Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense C, Denmark Kristina.holm@rsyd.dk.
Insights
This study protocol outlines a new intervention to support first-time fathers of preterm infants. The goal is to enhance paternal involvement and improve infant development outcomes during neonatal intensive care unit stays.
Area of Science:
- Neonatal care
- Paternal involvement
- Complex interventions
Background:
- Fathers of preterm infants desire active caregiving roles.
- Paternal involvement positively impacts preterm infant development.
- Fathers may feel excluded in neonatal intensive care units (NICUs).
Purpose of the Study:
- To develop and implement a complex intervention for first-time fathers of preterm infants.
- To support fathers during the early parenthood period.
- To evaluate the intervention's impact on parental well-being and infant development.
Main Methods:
- Adherence to the Medical Research Council framework for complex interventions.
- Multicentre, prospective, non-blinded, quasi-experimental design.
- Clinical and technology-based intervention for nurses and fathers, with 295 participants.
Main Results:
- Assessment of parental confidence, stress, depression, mood, and family functioning.
- Evaluation of infant emotional and social development.
- Comprehensive process evaluation using qualitative and quantitative methods.
Conclusions:
- The study protocol details a novel intervention to support first-time fathers of preterm infants.
- Implementation and evaluation will assess the intervention's effectiveness.
- Findings will be disseminated through peer-reviewed publications.
Introduction:
Fathers of preterm infants wish to be actively involved and attentive in caring for their children. The positive impacts of paternal caregiving on preterm infants' cognitive and social development have been recognised. Awareness of the need to support fathers during early parenthood is increasing, but fathers may feel excluded when their infants are in the neonatal intensive care unit. Here, we present the protocol for a study involving the development and national implementation of a complex intervention supporting first-time fathers of preterm infants in early parenthood.
Methods And Analysis:
The study adheres to the Medical Research Council framework for complex interventions. A multicentre, prospective, non-blinded, quasi-experimental design will be applied to evaluate the effect of a clinical and technology-based intervention targeting both nurses and the fathers. Outcomes from participants enrolled during the control (2023-2024) and intervention (2025-2026) periods, comprising 295 fathers and their partners, will be compared. Effects on parental confidence, stress, depression and mood and family and reflective functioning as well as infants' emotional and social development will be assessed. A comprehensive process evaluation will be applied using both qualitative and quantitative methods.
Ethics And Dissemination:
The study has been registered at Clinicaltrials.org [no. NCT0 6 116 747 (The SUPPORTED study - First-time Fathers of Preterm Infants), approved on 3 November 2023]. The Danish Data Protection Agency has approved the study (P-2022-792). The findings will be disseminated through peer-reviewed publications.
Trial Registration Number:
NCT06116747.
