Stockholm Preterm Interaction-Based Intervention

NCT03714633 | Active Not Recruiting

• 1 other identifier: TiSam
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 5

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.

Conditions

Extreme Prematurity

Keywords

cognitive development; motor development; parent-child interaction; parental mental health; strength-based intervention; prematurity

Outcome Measures

Primary Outcomes (1)

• Parent-child interaction

  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.

  12 months corrected age.

Secondary Outcomes (7)

• Child's general development

  24 months corrected age

• Child's executive function

  24 and 36 months corrected age

• Child's motor development 1

  3 months & 12 months corrected age

• Parental depression

  Term age, 12, 24 and 36 months corrected age

• Parental anxiety

  Term age, 12, 24 and 36 months corrected age

Other Outcomes (14)

• Child's neurological development

  3 months, 12 months, 24 months corrected age, hypothesis of higher score for intervention group

• Child's motor development 2

  Term age & 12 months corrected age, hypothesis of higher score for intervention group

• Child's motor development 3

  3 months corrected age

Study Arms (2)

Stockholm Preterm Interaction-Based Intervention (SPIBI)

EXPERIMENTAL

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.

Behavioral: Stockholm Preterm Interaction-Based Intervention (SPIBI)

Control

NO INTERVENTION

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.

Interventions

Stockholm Preterm Interaction-Based Intervention (SPIBI) BEHAVIORAL

Post-discharge intervention to extreme premature infants and their parents

Stockholm Preterm Interaction-Based Intervention (SPIBI)

Eligibility Criteria

• Age: 32 Weeks - 45 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stockholm University: lead
• Karolinska Institutet: collaborator
• Region Stockholm: collaborator
• Centrum för kompetensutveckling inom vård och omsorg, Stockholm University (funding): collaborator
• Clas Groschinskys Minnesfond, Sweden (funding): collaborator
• Queen Silvia Jubilee Fund for research on children and disability, Sweden (funding): collaborator
• Filénska fonden, Sweden (funding): collaborator

Study Sites (5)

Karolinska Hospital, Danderyds Sjukhus neonatalavdelning

Danderyd, 18288, Sweden

Location

Karolinska Hospital Huddinge, neontalavdelningen

Huddinge, 14186, Sweden

Location

Karolinska Hospital

Solna, 171 76, Sweden

Location

Stockholm University

Stockholm, 10691, Sweden

Location

Södersjukhusets neonatalavdelning

Stockholm, 11883, Sweden

Location

Related Publications (8)

• 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.

  PMID: 22406323 BACKGROUND

• 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.

  PMID: 18783797 BACKGROUND

• 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.

  PMID: 19880139 BACKGROUND

• 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.

  PMID: 20645992 BACKGROUND

• 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.

  PMID: 26597166 BACKGROUND

• 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.

  PMID: 32007087 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 33322234 RESULT

Related Links

• Link to project information

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ulrika Ådén, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor of the parent-child interaction using the emotional availability scales is blind to if the child belongs to the intervention Group or Control Group. Several outcomes are self assessment questionnaires, with no masking.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Special Education

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 22, 2018
• Study Start: September 1, 2018
• Primary Completion: January 3, 2023
• Study Completion: December 31, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)