Table 4 WHO Trial Registration Data Set (Version 1.3.1). Stockholm Preterm Interaction-Based Intervention
Trial information | Statues of SPIBI | ||
|---|---|---|---|
Primary Registry and Trial Identifying Number | Clinical Trials.gov NCT03714633 | ||
Date of Registration in Primary Registry | 22nd of October 2018 | ||
Secondary Identifying Numbers | No protocol number so far. Manual: TiSam – Tidigt Samspel för prematurfödda barn och deras föräldrar: Interventionunderlag | ||
Source (s) of Monetary or Material Support | Stockholm University, Sweden, department of Special Education, through faculty funds. Karolinska Institutet – department of Women’s and Children’s health, Sweden Stockholm County Council through the collaboration program with Stockholm University 2017–2019 (SU-SLL no. 20160881) Centrum för kompetensutveckling inom vård och omsorg at Stockholm University (CKVO) 2018–19 (no. SU FV 2.1.1–402,417) Clas Groschinskys Minnesfond 2018 (No. SF 18109) Queen Silvia Jubilee Fund for research on children and disability (date of letter of acceptance 13th of December 2017) Filénska fonden 2017/2018 K & A Wallenberg foundation (no. SU FV 2..1.9.1894–18) Lilla Barnets fond (2019-10-01) | ||
Primary Sponsor | Stockholm University | ||
Secondary Sponsor (s) | Karolinska Institutet | ||
Contact for Public Queries | Erika Baraldi, PhD student Stockholm University, erika.baraldi@specped.su.se + 46,812,076,462 | ||
Contact for Scientific Queries | PI: Ulrika Ådén, professor of neonatology Karolinska Institutet ulrika.aden@ki.se + 46,852,480,000 Mara Westling Allodi, professor of Special Education Stockholm University mara.allodi@specped.su.se + 468,162,000, + 46,734,612,522 | ||
Public Title | Tidigt samspelsbaserad intervention för extremt prematurfödda barn (TiSam) | ||
Scientific Title | Stockholm Preterm Interaction-Based Intervention (SPIBI); RCT of a 12-months parallel-group post-discharge program for extreme premature infants and their parents | ||
Countries of Recruitment | Sweden, Stockholm area | ||
Health Condition (s) or Problem (s) Studied | Extreme prematurity, parenthood of extremely preterm children | ||
Intervention (s) | Active comparator: Home-based post-discharge intervention for extremely premature infants 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 1 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. | ||
Control condition: 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. | |||
Key Inclusion and Exclusion Criteria | Inclusion Criteria: • extremely premature born infants • 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 | |||
Study Type | Interventional | ||
Study design Method; randomized Masking; Semi-masked, primary outcome assessor is blind to allocation Assignment; Parallel Purpose; The purpose of the SPIBI is to improve parent-child interaction, child development and parental mental health | |||
Phase; Not fully applicable, Phase II/Phase III | |||
Date of First Enrollment | September 2018 | ||
Sample Size | Planned: 130 | ||
Today (22nd of November 2019): 48 | |||
Recruitment Status | Recruiting | ||
Primary Outcome (s) | Emotional Availability of parent and child measured with Emotional Availability Scales EAS. | ||
Time point: 12 months corrected age | |||
Method: Video Observation of 20 min parent-child interaction, assessed with the manualized method of EAS consisting of 4 parent-specific domains and 2 child-specific domains. | |||
Key Secondary Outcomes | Bayley scales of infant and toddler development third edition, BSID-III | 24 months corrected age | Child assessment |
Behavior Rating of Executive Function Parental version BRIEF-P | 24 and 36 months corrected age | Parent questionnaire of child behavior | |
Alberta Infant Motor Scale, AIMS | 3 and 12 months corrected age | Observation and assessment of child motor development | |
Hospital anxiety and depression scale, HADS | 12, 24 and 36 months corrected age | Parent questionnaire of depressive symptoms | |
State/trait anxiety inventory, STAI | 12, 24 and 36 months corrected age | Parent questionnaire of symptoms of anxiety | |
Parental self-efficacy scale, PSE | 12, 24 and 36 months corrected age | Parent questionnaire of parental self-efficacy | |
Resilience scale, RES | 12, 24 and 36 months corrected age | Parent questionnaire of parental self-efficacy | |
Ethics Review | SPIBI has been approved by the Regional Ethical Review Board in Stockholm ref. 2017/1596–31. | ||
Date of Approval 26th of October 2019. | |||
Contact: Göran Elinder, scientific secretary, kansli@stockholm.epn.se + 46,852,487,000 | |||
Completion date | Last day of recruitment: 31st of August 2020 (anticipated), may be later if target is not reached yet. | ||
Last visit: 31st of August 2021 (anticipated) or 1 year after the ast participant has been recruited. | |||
Data collection completion: 1st of September 2023 (anticipated) | |||
Summary Results | No results yet | ||
IPD sharing statement | Undecided | ||