Stockholm Preterm Interaction-Based Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stockholm Preterm Interaction-Based Intervention

Conditions
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Extreme Prematurity

Intervention / Treatment
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* Behavioral: Stockholm Preterm Interaction-Based Intervention (SPIBI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 32 Weeks
Maximum Age: 45 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stockholm Preterm Interaction-Based Intervention (SPIBI)<br>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)<br>* Post-discharge intervention to extreme premature infants and their parents<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child's general development | 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 | 24 months corrected age | 
| Child's executive function | Behaviour Rating of Executive Function Parental version BRIEF-P. All the 5 subscales will be used. Hypothesis of less executive problems in intervention group. | 24 and 36 months corrected age | 
| Child's motor development 1 | Alberta Infant Motor Scale, AIMS. Range 0 - 58 points, with a hypothesis of higher scores for intervention group | 3 months & 12 months corrected age | 
| Parental depression | 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. | Term age, 12, 24 and 36 months corrected age | 
| Parental anxiety | 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 | Term age, 12, 24 and 36 months corrected age | 
| Parental self-efficacy | 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. | Term age, 12, 24 and 36 months corrected age | 
| Parental resilience | Resilience scale, RES. RES is a 25-items scale with a 7-point Likert scale. Hypothesis of higher scores in the intervention group. | Term age, 12, 24 and 36 months corrected age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive development, motor development, parent-child interaction, parental mental health, strength-based intervention, prematurity