Research problem and specific questions More than 1000 very preterm infants (\< 32 weeks) are born every year in Sweden. They are at high risk of neurodevelopmental disabilities and mental illness throughout the lifespan. The overall purpose is to develop and evaluate a novel e-health intervention aimed at improving neurodevelopment (cognitive, motor, feeding, language, socio-emotional) of very preterm infants by supporting responsive parenting behaviours. The primary research question is whether the intervention improves child neurodevelopment up to 2 years. Further research questions relate to the emotional availability of parents and children, parental stress and overall experience as well as effects on health inequalities and gender effects. Data and method Using a multi-professional approach, the study team have developed a post-discharge "Intervention for Neurodevelopmental Support in Preterm Infants using Responsive parenting and E-health" (INSPIRE). Parents of very preterm infants will be included in the program at hospital discharge and will receive the intervention in 18 sessions over a two year period. The study team have assessed feasibility and refined the intervention in a pilot study including 9 families. This autumn, a randomized clinical trial will be performed to evaluate efficiency: Families will be randomized to the INSPIRE program or standard care. Follow-up and assessment of children (and parents) across a range of crucial domains will be performed up to at least 2 years of age. Societal relevance and utilisation The project will be the first in the world to use a digital e-health solution with video interaction to deliver a post discharge parental support intervention to parents of very preterm infants. The project has great potential to reduce the risk of cognitive impairment, behavioral problems, mental illness and eating disorders in these high risk children, as well as improving mental health and well-being in the parents. Parents of preterm infants are involved as co-creators in developing and evaluating the program. Plan for project realization Currently, there is no similar post-discharge program available. Based on the results, the study team aim to implement a sustainable, nationwide, post-discharge e-health intervention program to improve health in very preterm-born children and their parents, which will also reduce health inequality by ensuring the availability of high-quality support to families living far away from highly specialized health care facilities
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
176
The Intervention for Neurodevelopmental Support in Preterm Infants using Responsive parenting and E-health (INSPIRE) aims to support the infant's neurodevelopment by supporting the parents to develop a responsive approach. The intervention will enhance the infant's social and environmental interactions, focusing on developing both the infant's and parent's strengths, seeking opportunities instead of problems in behaviour, enhancing mutually satisfying interaction and parental empowerment.
Falu County Hospital
Falun, Dalarna County, Sweden
RECRUITINGÖstersund Hospital
Östersund, Jämtland Härjedalen, Sweden
RECRUITINGSunderby Hospital
Södra Sunderbyn, Norrbotten County, Sweden
RECRUITINGKarlstad Hospital
Karlstad, Värmland County, Sweden
RECRUITINGUmeå university hospital
Umeå, Västerbotten County, Sweden
RECRUITINGSundsvall Hospital
Sundsvall, Västernorrland County, Sweden
RECRUITINGÖrebro University Hospital
Örebro, Örebro County, Sweden
RECRUITINGBayley Scales of Infant Development (BSID IV)
Bayley Scales of Infant Development (BSID IV) is a test administered by a psychologist for assessment of general neurodevelopment (cognitive, language and motor) at 24 months corrected age (primary outcome)
Time frame: 24 months corrected age
Alberta infant motor scale (AIMS)
Alberta infant motor scale is a test performed by a physiotherapist, based on live observation or a video recording of the infant. We will use video recordings.
Time frame: 6 months corrected age.
Peabody Developmental Motor Scales (PDMS-2)
Peabody Developmental Motor Scales (PDMS-2) is a test, administered by a physiotherapist, to assess motor function.
Time frame: 24 months corrected age.
Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI IV)
Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI IV) is a test performed by a psychologist for assessment of cognitive development at 5.5 years of age.
Time frame: 5,5 years of age
Movement ABC
Movement ABC is a test administered by a physiotherapist for assessment of motor development at 5.5 years of age.
Time frame: 5,5 years of age
Strengths and Difficulties Questionnaire (SDQ)
Strengths and Difficulties Questionnaire (SDQ) is a parental questionnaire for assessment of behavioural problems
Time frame: 24 months corrected age, 36 months of age and 5,5 years of age
The Infant Toddler Checklist (ITC)
The Infant Toddler Checklist (ITC) is a questionnaire/method to assess early language development
Time frame: 18 months corrected age
The MacArthur-Bates Communicative Development Inventories (MB-CDIs)
The MacArthur-Bates Communicative Development Inventories (MB-CDIs) is a questionnaire/method to assess early language development.
Time frame: 12 and 18 months corrected age.
"Jollerobservation"
"Jollerobservation" is a Swedish standardised protocol for observation of babbling. The observation is performed by a speech- and language pathologist.
Time frame: 12 months corrected age.
The Montreal Children's Hospital Feeding Scale
The Montreal Children's Hospital Feeding Scale are a questionnaire that will be used for assessment of feeding development.
Time frame: 12 months corrected age.
The Emotional Availability Scale (EAS)
The Emotional Availability Scale (EAS) is an observational coding system to assess emotional availability during caregiver-infant interactions regarding both the parent and the child
Time frame: 12 months corrected age and 24 months corrected age.
The Parental Reflective Functioning Questionnaire (PRFQ)
The Parental Reflective Functioning Questionnaire (PRFQ) will be used to assess parents reflective functioning regarding their child's emotional needs
Time frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.
Modified Checklist for Autism in Toddlers (M-CHAT
Modified Checklist for Autism in Toddlers (M-CHAT) is a parental questionnaire for assessment of early signs of autism
Time frame: 24 months corrected age
The Reynell Developmental Language Scales IV (RDLS IV)
The Reynell Developmental Language Scales IV (RDLS IV) will be used for detailed assessment of language development.
Time frame: 36 months of age.
Ages and Stages Questionnaire (ASQ)
Ages and Stages Questionnaire (ASQ) is a parental questionnaire for assessment of general neurodevelopment
Time frame: 24 months corrected age
Swedish Parenthood Stress Questionnarie (SPSQ)
Swedish Parenthood Stress Questionnarie (SPSQ) is a questionnaire that measures stress.
Time frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.
Resilience Scale (RES)
Resilience Scale (RES) is a questionnaire that measures resilience.
Time frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.
Parental Self-Efficacy Scale (PSE)
Parental Self-Efficacy Scale (PSE) is a questionnaire that measures parental self efficacy.
Time frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age, 24 months corrected age, and 36 months of age and 5,5 years of age.
The Hospital Anxiety and Depression scale (HAD)
The Hospital Anxiety and Depression scale (HAD) is a questionnaire that measures anxiety and depression. It will be used to assess parental mental health.
Time frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age.
The State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) is a questionnaire that measures anxiety. It will be used to assess parental mental health.
Time frame: At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age.
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