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Stockholm preterm interaction-based intervention (SPIBI) - study protocol for an RCT of a 12-month parallel-group post-discharge program for extremely preterm infants and their parents
Stockholm University, Faculty of Social Sciences, Department of Special Education.ORCID iD: 0000-0002-5285-0790
Stockholm University, Faculty of Social Sciences, Department of Special Education.ORCID iD: 0000-0003-2396-4710
Stockholm University, Faculty of Social Sciences, Department of Psychology, Clinical psychology.
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2020 (English)In: BMC Pediatrics, E-ISSN 1471-2431, Vol. 20, no 1, article id 49Article in journal (Refereed) Published
Abstract [en]

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).

Place, publisher, year, edition, pages
2020. Vol. 20, no 1, article id 49
Keywords [en]
child cognitive development, child motor development, early intervention, emotional availability, extreme prematurity, parent-child interaction, pediatrics
National Category
Pediatrics Psychology
Research subject
Pediatrics
Identifiers
URN: urn:nbn:se:su:diva-178772DOI: 10.1186/s12887-020-1934-4ISI: 000512710000001OAI: oai:DiVA.org:su-178772DiVA, id: diva2:1391611
Available from: 2020-02-05 Created: 2020-02-05 Last updated: 2025-09-05Bibliographically approved
In thesis
1. An Interaction-Based Early Intervention During the First Year of Life: Targeting Infants Born Extremely Preterm and Their Parents
Open this publication in new window or tab >>An Interaction-Based Early Intervention During the First Year of Life: Targeting Infants Born Extremely Preterm and Their Parents
2024 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

The first thousand days from conception are crucial for future learning and development throughout life. During the infant year, several sensitive periods for sensorimotor, cognitive and social development coincide, making the period particularly suitable for early intervention (EI). From a special educational perspective, the social and physical environment of a child may either support or hinder future growth. Optimal early learning environments include environmental enrichment, reduced toxic stress and strengths-based support of parent-child interaction.

Being born extremely preterm (EPT <28 gestational weeks) is a biological risk factor, increasing the risk for future disability, academic difficulties and social challenges. The parents are also negatively affected by prematurity. Sweden offers highly specialized neonatal care from 22 GW, resulting in a new population of surviving children.

The aim of this thesis is to evaluate an interaction-based and strengths-based EI for infants born EPT and their parents in a Swedish context. The Stockholm Preterm Interaction-Based Intervention (SPIBI) consists of 10 home visits led by a trained interventionist during the first year at home, focusing on parent-child interaction, family strengths and reduction of toxic stress. The control group received an extended treatment as usual follow-up program (TAU+). The thesis has a mixed methods design and includes three studies.

Study I presents the protocol, including a description of the planning, formulation, theoretical background, theory of change, interventionist training, recruitment, randomization and implementation of the SPIBI. Study II reports the primary outcome of the RCT (N=130, intervention=66 vs. controls=64) and their parents regarding parent-child interaction as measured with the Emotional Availability Scale (EAS) at 12 months corrected age (CA). The EAS consists of the six dimensions: sensitivity, structuring, non-intrusiveness, non-hostility, child responsiveness and child involvement. No significant effect of the EAS at 12 months CA related to the SPIBI was found. In the secondary analysis, analysis of covariances for all EAS dimensions were tested with predefined medical, social, and psychological moderators. The model with the best fit was one for the EAS dimension child involvement (adj R2=.463). A significant effect modifier shows that the SPIBI enhances child involvement in families where the mothers rate themselves as depressed at discharge (F(1, 65)=5.499, p=.023).The parental experience during the first year at home with or without the SPIBI was qualitatively analyzed and reported in Study III (n=17). The results showed that child-related medical concerns were still present a year post-discharge, and that the premature birth experience still affected the parental inner state and family dynamics. Parents in the intervention group (n=8) also pointed out the security the knowledgeable interventionists gave them, while some parents described the SPIBI as important but not necessary.

Overall, this thesis adds to the understanding of the first year at home with a child born EPT. An interaction-based intervention in the home environment is feasible in Sweden. It is possible to unite different professions in an EI in a special educational context. The tested intervention does not affect the emotional availability at 1 year CA, but findings from secondary analyses prompt further research on specific subgroups, particularly families with depressed mothers. 

Place, publisher, year, edition, pages
Stockholm: Department of Special Education, Stockholm University, 2024. p. 134
Keywords
Early intervention, emotional availability, extreme preterm birth, parental experiences, parent-child interaction, home-visiting program, parental mental health, parental support, post-discharge intervention, randomized control trial
National Category
Educational Sciences
Research subject
Special Education
Identifiers
urn:nbn:se:su:diva-227919 (URN)978-91-8014-745-3 (ISBN)978-91-8014-746-0 (ISBN)
Public defence
2024-05-24, Auditorium 4, house 2, Albano, Albanovägen 18 and online via Zoom, public link is available through the department website, Stockholm, 13:00 (English)
Opponent
Supervisors
Available from: 2024-04-29 Created: 2024-04-03 Last updated: 2025-09-05Bibliographically approved

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Zettby, ErikaWestling Allodi, MaraLöwing, KristinaSmedler, Ann-CharlotteWestrup, BjörnÅdén, Ulrika

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