Clinical trial NCT03714633: Stockholm Preterm Interaction-Based Intervention
Official title: Stockholm Preterm Interaction-Based Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Extreme Prematurity
Keywords: cognitive development
motor development
parent-child interaction
parental mental health
strength-based intervention
prematurity
Lead sponsor: Stockholm University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Region Stockholm
name: Centrum för kompetensutveckling inom vård och omsorg, Stockholm University (funding)
name: Clas Groschinskys Minnesfond, Sweden (funding)
name: Queen Silvia Jubilee Fund for research on children and disability, Sweden (funding)
name: Filénska fonden, Sweden (funding)
First posted: 2018-10-22
Enrollment: 130
Sex: ALL
Minimum age (years): 32
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parent-child interaction
timeFrame: 12 months corrected age.
Secondary outcomes:
measure: Child's general development
timeFrame: 24 months corrected age
measure: Child's executive function
timeFrame: 24 and 36 months corrected age
measure: Child's motor development 1
timeFrame: 3 months & 12 months corrected age
measure: Parental depression
timeFrame: Term age, 12, 24 and 36 months corrected age
measure: Parental anxiety
timeFrame: Term age, 12, 24 and 36 months corrected age
measure: Parental self-efficacy
timeFrame: Term age, 12, 24 and 36 months corrected age
measure: Parental resilience
timeFrame: Term age, 12, 24 and 36 months corrected age
Other outcomes:
measure: Child's neurological development
timeFrame: 3 months, 12 months, 24 months corrected age, hypothesis of higher score for intervention group
measure: Child's motor development 2
timeFrame: Term age & 12 months corrected age, hypothesis of higher score for intervention group
measure: Child's motor development 3
timeFrame: 3 months corrected age
measure: Child's general development
timeFrame: 12 months, 24 months, 36 months corrected age, hypothesis that the parents of the intervention group scoring their children higher
measure: Child's strengths and difficulties
timeFrame: 24 and 36 months corrected age, hypothesis of less difficulties and more strengths scored by parents in the intervention group
measure: Child's autistic symptoms
timeFrame: 24 months corrected age
measure: Infant temperament
timeFrame: 12 months corrected age
measure: Parental satisfaction with the intervention
timeFrame: 12 months corrected age
measure: Pre-school educators' view of the child's engagement in preschool
timeFrame: 24 and 36 months corrected age
measure: Pre-school educators' view of the child's interaction in preschool
timeFrame: 24 and 36 months corrected age
measure: Pre-school educators' view of the child's playtime in preschool
timeFrame: 24 and 36 months corrected age
measure: Pre-school educators' view of the child in preschool
timeFrame: 24 or 36 months corrected age, depending on when the child has entered preschool
measure: Pre-school educators' view of the child's level of function in preschool
timeFrame: 24 and 36 months corrected age
measure: Parent-child interaction long-term
timeFrame: 24 months corrected age
Locations:
city: Danderyd
country: Sweden
facility: Karolinska Hospital, Danderyds Sjukhus neonatalavdelning
city: Huddinge
country: Sweden
facility: Karolinska Hospital Huddinge, neontalavdelningen
city: Solna
country: Sweden
facility: Karolinska Hospital
city: Stockholm
country: Sweden
facility: Stockholm University
city: Stockholm
country: Sweden
facility: Södersjukhusets neonatalavdelning
Study officials:
affiliation: Karolinska Institutet
name: Ulrika Ådén, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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;2015(11):CD005495. doi: 10.1002/14651858.CD005495.pub4.
citation: Baraldi E, Allodi MW, Lowing K, Smedler AC, Westrup B, Aden 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.
citation: 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
citation: Baraldi E, Allodi MW, Smedler AC, Westrup B, Lowing K, Aden U. Parents' Experiences of the First Year at Home with an Infant Born Extremely Preterm with and without Post-Discharge Intervention: Ambivalence, Loneliness, and Relationship Impact. Int J Environ Res Public Health. 2020 Dec 13;17(24):9326. doi: 10.3390/ijerph17249326.