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Stockholm preterm interaction-based intervention (SPIBI) - study protocol for an RCT of a 12-month parallel-group
Erika Baraldi1, Mara Westling Allodi2, Kristina Löwing3,4
1Department of Special Education, Specialpedagogiska institutionen Stockholms universitet, Stockholm University, Frescati Hagväg 10, 106 91, Stockholm, Sweden. erika.baraldi@specped.su.se.
Insights
This study introduces the Stockholm Preterm Interaction-Based Intervention (SPIBI) for extremely preterm infants and their parents. The trial evaluates early intervention
Area of Science:
- Neonatal care and developmental pediatrics.
- Early childhood intervention research.
- Parent-infant relationship studies.
Background:
- Improved neonatal survival increases the number of extremely preterm (EPT) infants facing neurodevelopmental challenges.
- EPT children are at higher risk for cognitive deficits, particularly in executive functions.
- Parent-child interaction and parental mental health are crucial for infant development, irrespective of birth status.
Purpose of the Study:
- To describe the Stockholm Preterm Interaction-Based Intervention (SPIBI) program.
- To outline the design and arrangements of the SPIBI randomized clinical trial.
- To detail the selected outcome measurements for assessing intervention effectiveness.
Main Methods:
- A randomized clinical trial involving EPT infants and their parents post-NICU discharge in Stockholm, Sweden.
- Intervention group receives home visits and telephone support focusing on parental sensitivity and co-regulation.
- Control group receives standard care; outcomes include parent-child interaction, child development, and parental mental health assessed up to 36 months corrected age.
Main Results:
- Primary outcome is emotional availability at 12 months corrected age.
- Secondary outcomes assess child development, parental mental health, and preschool participation.
- Data collection occurs at 3, 12, 24, and 36 months corrected age.
Conclusions:
- The SPIBI trial will provide valuable data on EPT children and their families.
- Positive findings may support clinical implementation for child support, ethical, and health-economic reasons.
- The study contributes to understanding early intervention effectiveness in this vulnerable population.
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).
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