Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health (INSPIRE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 7
- 主要终点
- Bayley Scales of Infant Development (BSID IV)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Infant born before 32 GV, or with birth weight under 1500 gr.
排除标准
- •Parent(s) younger than 18 ya.
- •Chromosomal abnormalities, congenital syndromes that may affect the child's development.
- •Parents unable to understand Swedish.
- •Parents with severe mental illness or a physical medical condition requiring extensive inpatient care.
- •Families without a stable living situation, such as parental substance abuse, homelessness, or family living under threat of deportation from Sweden.
- •Families that have previously participated in the INSPIRE study or the INSPIRE pilot study.
研究组 & 干预措施
Controll group
Standard care
INSPIRE-intervention
Intervention group, recieving the INSPIRE-intervention
干预措施: Neurodevelopmental support (Behavioral)
结局指标
主要结局
Bayley Scales of Infant Development (BSID IV)
时间窗: 24 months corrected age
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)
次要结局
- Alberta infant motor scale (AIMS)(6 months corrected age.)
- Peabody Developmental Motor Scales (PDMS-2)(24 months corrected age.)
- Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI IV)(5,5 years of age)
- Movement ABC(5,5 years of age)
- Strengths and Difficulties Questionnaire (SDQ)(24 months corrected age, 36 months of age and 5,5 years of age)
- The Infant Toddler Checklist (ITC)(18 months corrected age)
- The MacArthur-Bates Communicative Development Inventories (MB-CDIs)(12 and 18 months corrected age.)
- "Jollerobservation"(12 months corrected age.)
- The Montreal Children's Hospital Feeding Scale(12 months corrected age.)
- The Emotional Availability Scale (EAS)(12 months corrected age and 24 months corrected age.)
- The Parental Reflective Functioning Questionnaire (PRFQ)(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(24 months corrected age)
- The Reynell Developmental Language Scales IV (RDLS IV)(36 months of age.)
- Ages and Stages Questionnaire (ASQ)(24 months corrected age)
- Swedish Parenthood Stress Questionnarie (SPSQ)(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)(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)(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)(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)(At enrollment (at 38-42 weeks postmenstrual age), at 12 months corrected age and 5,5 years of age.)