Stockholm Preterm Interaction-Based Intervention

Overview

Extreme premature Children will at discharge from Karolinska Hospital and Södersjukhuset in Stockholm be asked to participate in a study, examining the effects of a home-visit based post-discharge program aiming at facilitating the interaction between infants and parents, improving the development of the children, and the parental mental health. The study is a randomized controlled Trial (RCT), hence 50% of the participants will be offered treatment as usual (TAU) with addition of an extended follow-up program. The interaction-based program consists of one initial visit at the hospital followed by nine home-visits and two telephone calls during the child's first year of life. The interventionists are skilled Healthcare professionals with several years of experience from caring for premature infants and their parents. All interventionists have successfully completed a one year further education program, delivered one day per week and containing theoretical lectures, practice with actual cases, supervision on the cases, visits to the different parts of the neonatal care chain and discussions with a representative from the premature family association Sweden.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2021

Detailed Description

Detailed description of the intervention: the purpose of the initial visit at the neonatal unit or hospital ward where the child is still treated is to establish the foundation for the interventionist/family relationship and give the parent(-s) the opportunity to show the interventionist the environment where the infant has spent his/her first 3-5 months in life. Home-visit 1-3 and two telephone calls are provided before the child is three months corrected age. The focus of these home visits is to observe child and parent at home and validate the child's strengths and competences as well as enhancing the parent-child interaction, building on strengths. The child's strengths and interests will be summarized in a logbook owned by the parents. During home-visit 4-8 the interventionist, step by step and always with great regard to the child's level of development, will support the parent in using the home-environment in a developmental supporting manner for the child, find suitable objects/toys at home for the child to examine with mouth, hands and body, confirm the child's abilities and give suggestions on how to stimulate the child's further development. The logbook will now also contain suggestions for supporting the next developmental step, which will be formulated by the interventionist together with the parent. The ninth and last home-visit will emphasize the child's progress during the past year, look through the family logbook and both summarize the past year and talk about the next developmental step for the future. The intervention group receives the standard follow-up program just as the control group and will be referred to specialized care when needed. Compared to children not participating in the study, the study participants will receive an extended follow-up program, with assessment and questionnaires at term age, 3 months corrected age, 12 months corrected age, 24 months corrected age and 36 months corrected age. The research process and the study protocol have been published, see references below.

Interventions

  • Behavioral: Stockholm Preterm Interaction-Based Intervention (SPIBI)
    • Post-discharge intervention to extreme premature infants and their parents

Arms, Groups and Cohorts

  • Experimental: Stockholm Preterm Interaction-Based Intervention (SPIBI)
    • Home-based post-discharge intervention for extreme premature babies and their parents. The intervention consists of one hospital visit, nine home-visits and two telephone calls during the first year corrected age, specifically from one week before discharge to 12 months corrected age. The intervention is strengths-based working with the infant-parent interaction, supporting infant development and strengthening the parent in his/her role.
  • No Intervention: Control
    • The participants of the Control Group receives treatment as usual, which consists of a regular follow-up program with neurodevelopmental assessment at term age, 3 months corrected age, 12 months corrected age, 24 months corrected age and 66 months corrected age. Compared to children not participating in the study, the control group will receive an extended follow-up program, with assessment and questionnaires at term age, 3 months corrected age, 12 months corrected age, 24 months corrected age and 36 months corrected age. Participants in the control group will be referred to specialized care when needed.

Clinical Trial Outcome Measures

Primary Measures

  • Parent-child interaction
    • Time Frame: 12 months corrected age.
    • Emotional availability scales, EAS The scale has four parental dimensions; sensitivity, structure, non-intrusiveness, non-hostility and two child dimensions; child responsiveness and child involvement. Each subscale has a maximum score of 29 and a direct score of 1-7. Hypothesis of higher scores in intervention group.

Secondary Measures

  • Child’s general development
    • Time Frame: 24 months corrected age
    • Bayley scales of infant and toddler development (third edition; Bayley-III), measuring cognition, language, and motor development. Composite scores are standardized to mean (SD) scores of 100 (15), based on age-matched normative data. Higher scores in intervention group
  • Child’s executive function
    • Time Frame: 24 and 36 months corrected age
    • Behaviour Rating of Executive Function Parental version BRIEF-P. All the 5 subscales will be used. Hypothesis of less executive problems in intervention group.
  • Child’s motor development 1
    • Time Frame: 3 months & 12 months corrected age
    • Alberta Infant Motor Scale, AIMS. Range 0 – 58 points, with a hypothesis of higher scores for intervention group
  • Parental depression
    • Time Frame: Term age, 12, 24 and 36 months corrected age
    • Hospital anxiety and depression scale, HADS. Range depression subscale 0-21, range anxiety subscale 0-21. Hypothesis of lower scores in the intervention-parental group.
  • Parental anxiety
    • Time Frame: Term age, 12, 24 and 36 months corrected age
    • State/trait anxiety inventory, STAI. Maximum 80 points for the State-scale, and maximum 80 points for the trait-scale. Hypothesis of lower scores in the intervention-parental group
  • Parental self-efficacy
    • Time Frame: Term age, 12, 24 and 36 months corrected age
    • parental self-efficacy scale, PSE. PSE has 24 items at term age and 12 and 24 months and 48 items int he form for older ages, all items rated in a 0-10 scale. Hypothesis of higher score for intervention group at 12,24 and 36 months.
  • Parental resilience
    • Time Frame: Term age, 12, 24 and 36 months corrected age
    • Resilience scale, RES. RES is a 25-items scale with a 7-point Likert scale. Hypothesis of higher scores in the intervention group.

Participating in This Clinical Trial

Inclusion Criteria

  • extremely premature born babies – close to discharge from their neonatal intensive care unit hospital stay at Stockholm county council (Stockholms Läns Landsting). Exclusion Criteria:

  • Children with parent/parents who do not communicate in Swedish or English. – Patients not residing in Stockholm county. – Acute surgery patients who will spend a lot of time at hospitals far from Stockholm

Gender Eligibility: All

Minimum Age: 32 Weeks

Maximum Age: 45 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stockholm University
  • Collaborator
    • Karolinska Institutet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Professor Mara Westling Allodi, Professor in Special Education – Stockholm University
  • Overall Official(s)
    • Ulrika Ådén, MD PhD, Principal Investigator, Karolinska Institutet
  • Overall Contact(s)
    • Erika Baraldi, PhD Student, +46812076462, erika.baraldi@specped.su.se

References

Verkerk G, Jeukens-Visser M, Houtzager B, Koldewijn K, van Wassenaer A, Nollet F, Kok J. The infant behavioral assessment and intervention program in very low birth weight infants; outcome on executive functioning, behaviour and cognition at preschool age. Early Hum Dev. 2012 Aug;88(8):699-705. doi: 10.1016/j.earlhumdev.2012.02.004. Epub 2012 Mar 10.

Koldewijn K, Wolf MJ, van Wassenaer A, Meijssen D, van Sonderen L, van Baar A, Beelen A, Nollet F, Kok J. The Infant Behavioral Assessment and Intervention Program for very low birth weight infants at 6 months corrected age. J Pediatr. 2009 Jan;154(1):33-38.e2. doi: 10.1016/j.jpeds.2008.07.039. Epub 2008 Sep 10.

Koldewijn K, van Wassenaer A, Wolf MJ, Meijssen D, Houtzager B, Beelen A, Kok J, Nollet F. A neurobehavioral intervention and assessment program in very low birth weight infants: outcome at 24 months. J Pediatr. 2010 Mar;156(3):359-65. doi: 10.1016/j.jpeds.2009.09.009. Epub 2009 Nov 2.

Meijssen DE, Wolf MJ, Koldewijn K, van Wassenaer AG, Kok JH, van Baar AL. Parenting stress in mothers after very preterm birth and the effect of the Infant Behavioural Assessment and Intervention Program. Child Care Health Dev. 2011 Mar;37(2):195-202. doi: 10.1111/j.1365-2214.2010.01119.x.

Spittle A, Orton J, Anderson PJ, Boyd R, Doyle LW. Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants. Cochrane Database Syst Rev. 2015 Nov 24;(11):CD005495. doi: 10.1002/14651858.CD005495.pub4. Review.

Baraldi E, Allodi MW, Löwing K, Smedler AC, Westrup B, Ådén U. 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. BMC Pediatr. 2020 Feb 1;20(1):49. doi: 10.1186/s12887-020-1934-4.

Baraldi, E., Westling Allodi, M., Löwing, K., Smedler, A.-C., Westrup, B., & Ådén, U. (2019). Clinical Protocol & Research Process of Stockholm Preterm Interaction-Based Intervention, SPIBI. Pediatric Research, 86(Suppl.), 54-55. https://doi.org/10.1038/s41390-019-0521-6

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