Early Prevention of Social Inequality in Health - an Interdisciplinary and Cross-sectorial Intervention for Vulnerable Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Maternal sensitivity
研究概览
简要总结
The aim of the project is to develop and evaluate an interdisciplinary and cross-sectorial intervention targeting pregnant women with psychosocial vulnerabilities. The objective is to 1) detect depression, anxiety and personality disorders in the pregnant women, 2) to increase knowledge sharing across the health care sectors and 3) strengthen the parents' parenting skills and thereby support a secure attachment between parents and child and thus promoting the child's well-being.
The overriding hypothesis is that an early multi-stringed, interdisciplinary and cross-sectorial intervention, with a long-term perspective from the early pregnancy throughout the child's first years of life, can effectively prevent disorders in the parent-child relation. The approach is to detect and treat depression, anxiety and personality disorders in the mother and strengthen the parents' parenting skills in families with maternal psychosocial vulnerabilities. The hypothesis indicates that the over-all intervention will result in improved interaction between child and parents which will make it possible to detect higher maternal sensitivity and a higher level of well-being among both children and parents in the intervention group compared to the control group.
The projects' specific hypotheses are;
- A systematic screening for anxiety, depression and personality disorders in the midwifery consultation will imply more pregnant women with symptoms of anxiety, depression and personality disorders being detected and offered treatment in the intervention group compared to the control group.
- Knowledge sharing across health care sectors will improve by the implementation of a joint consultation involving the vulnerable pregnant woman/families, the midwife and the health visitor and by a systematic transmission of information when the woman leaves the post-natal ward and is transferred to the health visitor.
- Parental skills in psychosocial vulnerable pregnant women and their partners can be strengthened by a parental training program and by education and dialogue about perceived challenges and breast-feeding. Parents in the intervention group will therefore gain greater knowledge on what it takes to make breast-feeding work successfully, be able to interact more appropriate with their children, and improve their mentalization skills and experience less stress compared to parents in the control group.
详细描述
Design, material and method:
The project will be conducted as a randomized controlled trial. The intervention group will receive a specific intervention and the control group will receive care as usual, in this context the standard treatment in antenatal care for vulnerable pregnant women and by the health visitor.
Study setting:
The intervention will be executed on Herlev-Gentofte Hospital in Denmark and in four of the affiliated municipalities: Ballerup, Gentofte, Herlev and Rødovre.
Target group:
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with psychological/psychiatric problems (care level 3*)
- •Pregnant women with severe social problems, either economic or familiar (care level 3*)
- •Pregnant women from the municipality of Ballerup, Gentofte, Herlev and Rødovre
排除标准
- •Pregnant women that exclusively has incident or chronic somatic illnesses (care level 3*)
- •Pregnant women with problems related to alcohol, drugs and/or medicine (care level 4*)
- •Pregnant women that does not speak/understand the Danish language
- •Pregnant women under the age of 18
- •The following diagnosis: Active eating disorder, Severe depression , Psychosis, Schizophrenia, Bipolar disorder.
结局指标
主要结局
Maternal sensitivity
时间窗: The mother-child relation will be videotaped and assessed during a home-visit by the health visitor after the intervention is finished when the child is around 9 months old.
Sensitive responses, that is the ability to respond appropriately to the child's attachment needs, has consistently been found to be the most reliable predictor of attachment security. The intervention, including The Circle of Security, has the aim to promote maternal sensitivity. The measurement tool "Coding Interactive Behaviour" (CIB) will be used to code maternal sensitivity towards the child. Maternal sensitivity is observed during 5 minutes interaction (free play) between mother and infant. CIB has good psychometric properties and has been validated in multiple longitudinal studies across cultures and across age groups (from newborn to adolescent). The system has previously been used for the purpose of research of the relation between a child and a mother with mental illness(es). Moreover, it has been used to evaluate the effectiveness of interventions.
次要结局
- Prenatal Parental Reflective Functioning Questionnaire(Baseline)
- Parental Reflective Functioning Questionnaire(Second follow-up:15 months after baseline (child 9 months old))
- The Parenting Stress Index(Second follow-up:15 months after baseline (child 9 months old))
- Edinburgh Postnatal Depression Scale(Baseline, first follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old))
- Maternal Antenatal Attachment Scale(Baseline)
- Ages and Stages Questionnaire - Social Emotional(Second follow-up:15 months after baseline (child 9 months old))
- Attitude towards breast-feeding(Baseline)
- Birth weight(At birth)
- Length at birth(At birth)
- Questions regarding the intervention(First and second follow up)
- Family and Social Support Scale(First follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old))
- Head circumference at birth(At birth)
- Experiences in Close Relationship - revised version(Baseline, first follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old))
- APGAR-score(At birth)
- Maternal sensitivity(The mother-child relation will be videotaped and assessed during a home-visit by the health visitor when the child is around 1 month.)
- Warwick Edinburg Mental Well-being Scale(Baseline, first follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old))
- Breast-feeding status(First follow-up: 7 months after baseline (child 1 month old) and second follow-up:15 months after baseline (child 9 months old))