Stockholm Preterm Interaction-Based Intervention
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 10
- 主要终点
- Parent-child interaction
研究概览
简要总结
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.
详细描述
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.
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
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 32 Weeks 至 45 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •extremely premature born babies
- •close to discharge from their neonatal intensive care unit hospital stay at Stockholm county council (Stockholms Läns Landsting).
排除标准
- •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
结局指标
主要结局
Parent-child interaction
时间窗: 12 months corrected age.
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.
次要结局
- Child's general development(24 months corrected age)
- Child's motor development 1(3 months & 12 months corrected age)
- Parental self-efficacy(Term age, 12, 24 and 36 months corrected age)
- Child's executive function(24 and 36 months corrected age)
- Parental resilience(Term age, 12, 24 and 36 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)
研究者
Professor Mara Westling Allodi
Professor in Special Education
Stockholm University