The Effectiveness of MInding the Baby in a Danish Community Sample
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Maternal sensitivity measured by the CIB (Coding Interactive Behavior)
研究概览
简要总结
Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. MTB is delivered by an interdisciplinary team. Ten Danish sites will be randomized to training at time 1 or 2 and recruit usual care control families before they receive the training. Families are assessed before they give birth and when their child is three months, one and two years old with a range of assessments including maternal sensitivity, parent mental Health, child development, and health related register data. The aim of the trial is to assess the effectiveness of Minding the Baby to improve mother-child relations and the mental health of parents and children.
详细描述
Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. The focus of the intervention is to reduce negative infant and maternal outcomes and strengthen the attachment relationship. MTB is delivered by an interdisciplinary team of highly skilled practitioners, who have health and social work experience, integrating advanced practice nursing and mental health care for mothers and infants. In the proposed Randomised Control Trial (RCT) the investigators will study the efficacy of this innovative intervention across ten Danish sites. Site staff will be trained at two sessions one year apart. Sites are randomized to training at time 1 or 2. All sites will recruit treatment as usual control families before they receive the training and start offering the intervention to all families. Potential participants will be approached by a local front staff member (e.g. midwife, helath visitor or social worker) who will inform mothers of the project in the early pregnancy. Consenting eligible participants will be assessed before they give birth and when their child is three months, one and two years old.
The effectiveness of the MTB programme will be evaluated by assessing a range of maternal and infant outcomes, including maternal sensitivity, parent mental Health, child development, and register data on e.g. infant maltreatment and neglect, hospitalization, income, immunization. By combining parent report, observational and register data researchers will get a unique opportunity to advance knowledge regarding effective ways to support some of the youngest and most vulnerable children in Denmark.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
As the intervention is a home visiting intervention participants and care providers cannot be blinded. Outcome assessor and data analyst will be blinded.
入排标准
- 年龄范围
- 15 Years 至 —(Child, Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant vulnerable women
排除标准
- •Current severe substance abuse
- •Severe psychotic illness
- •Profound or severe learning disabilities
- •Life-threatening illness in parent or child
- •Non-Danish speaking
结局指标
主要结局
Maternal sensitivity measured by the CIB (Coding Interactive Behavior)
时间窗: at child age 24 months
Maternal sensitivity
次要结局
- Coding interactive bahavior (CIB)(child age 12 and 24 months)
- Maternal sensitivity measured by the CIB (Coding Interactive Behavior)(Child age 12 months)
- Parental Stress Scale (PSS)(12 ,24 months)
- SEAM Family profile(12 months)
- Parent behavior Inventory (PBI)(12 and 24 months)
- Edinburgh Postnatal depression Scale (EPDS)(3, 12 , 24 months)
- Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)(3, 12 and 24 months)
- Parental reflective functioning questionnaire (PRFQ-1)(12 and 24 months)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, 3, 12,24 months)
- Being a Mother (BAM-13)(3 months)
- Warwick-Edinburgh Mental Well-being Scale(Baseline, 3, 12 , 24 months)
- 2-5(24 months)
- Prenatal Parental reflective functioning questionnaire (P-PRFQ)(Baseline)
- Ages and Stages Questionnaire 3 (ASQ:3)(3 months)
- Acitvities with child(12 and 24 months)
- PTSD-8(Baseline, 12 and 24 months)
- Experiences in Close Relationship Scale-Short Form (ECR-S)(Baseline, 12, 24 months)
研究者
Maiken Pontoppidan
Researcher
VIVE - The Danish Center for Social Science Research
