Background: Improved neonatal care has resulted in increased survival rates among infants born after only 22 gestational weeks, but extremely preterm children still have an increased risk of neurodevelopmental delays, learning disabilities and reduced cognitive capacity, particularly executive function deficits. Parent-child interaction and parental mental health are associated with infant development, regardless of preterm birth. There is a need for further early interventions directed towards extremely preterm (EPT) children as well as their parents. The purpose of this paper is to describe the Stockholm Preterm Interaction-Based Intervention (SPIBI), the arrangements of the SPIBI trial and the chosen outcome measurements.

Methods: The SPIBI is a randomized clinical trial that includes EPT infants and their parents upon discharge from four neonatal units in Stockholm, Sweden. Inclusion criteria are EPT infants soon to be discharged from a neonatal intensive care unit (NICU), with parents speaking Swedish or English. Both groups receive three initial visits at the neonatal unit before discharge during the recruitment process, with a strengths-based and development-supportive approach. The intervention group receives ten home visits and two telephone calls during the first year from a trained interventionist from a multi-professional team. The SPIBI intervention is a strengths-based early intervention programme focusing on parental sensitivity to infant cues, enhancing positive parent-child interaction, improving self-regulating skills and supporting the infant’s next small developmental step through a scaffolding process and parent-infant co-regulation. The control group receives standard follow-up and care plus extended assessment. The outcomes of interest are parent-child interaction, child development, parental mental health and preschool teacher evaluation of child participation, with assessments at 3, 12, 24 and 36 months corrected age (CA). The primary outcome is emotional availability at 12 months CA.

Discussion: If the SPIBI shows positive results, it could be considered for clinical implementation for child-support, ethical and health-economic purposes. Regardless of the outcome, the trial will provide valuable information about extremely preterm children and their parents during infancy and toddlerhood after regional hospital care in Sweden.

Trial registration: The study was registered in ClinicalTrials.gov in October 2018 (NCT03714633).

Aim: To determine whether a strength-based home-visiting program enhances parent–child interaction during the first year at home for children born extremely preterm (gestational age < 28).

Methods: A randomised controlled trial of 130 infants born extremely preterm 2018–2021 in Stockholm, allocated to either the Stockholm preterm interaction-based intervention (SPIBI) (n = 66) or an extended follow-up program (n = 64). The intervention group received ten home visits during the first year by a trained interventionist following SPIBI guidelines: an interaction-based intervention supporting sensitive parental responses to infants' signals. The primary outcome of emotional availability was assessed at 12 months corrected age (CA) using the emotional availability scales (EAS).

Results: At 1-year CA, data were collected from 115/130 (89%) of the included children. There were no significant group differences in emotional availability at 12 months CA. A secondary analysis showed an effect modifier in families with mothers self-rated as depressed at discharge, with the outcome favouring intervention in the EAS dimension of child involvement.

Conclusion: The SPIBI had no significant main effect on emotional availability at 12 months CA. Children of self-reported depressed mothers displayed superior involvement behaviour in the intervention group, prompting further research on risk groups and potential modifications of post-discharge interventions.

With increasing survival rates of children born extremely preterm (EPT), before gestational week 28, the post-discharge life of these families has gained significant research interest. Quantitative studies of parental experiences post-discharge have previously reported elevated levels depressive symptoms, posttraumatic stress-disorder and anxiety among the parents. The current investigation aims to qualitatively explore the situation for parents of children born EPT in Sweden during the first year at home. Semi-structured interviews were performed with 17 parents of 14 children born EPT; eight parents were from an early intervention group and nine parents from a group that received treatment as usual, with extended follow-up procedures. Three main themes were identified using a thematic analytic approach: child-related concerns, the inner state of the parent, and changed family dynamics. Parents in the intervention group also expressed themes related to the intervention, as a sense of security and knowledgeable interventionists. The results are discussed in relation to different concepts of health, parent–child interaction and attachment, and models of the recovery processes. In conclusion, parents describe the first year at home as a time of prolonged parental worries for the child as well as concerns regarding the parent’s own emotional state.