The Effects of Family Clinic and Municipality (FACAM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 332
- 试验地点
- 4
- 主要终点
- Maternal sensitivity
研究概览
简要总结
This trial is a randomized controlled trial with the aim is to assess the effectiveness of Family Clinic and Municipality (FACAM) to improve mother-child relationship, maternal health, maternal mental health, and the development and well-being of the child.
详细描述
Pregnant women who struggle with psychosocial challenges during pregnancy have a higher risk of preterm birth, giving birth to a child with low birth weight and a higher risk of complications during pregnancy both for mother and child. An early and coordinated intervention to reduce inequality in health may be important for this group of vulnerable women.
The FACAM intervention is developed in Odense with the aim of reducing inequality in health by giving vulnerable pregnant women and their children the best possible start in life by offering an interdisciplinary coordinated support. The support will be offered by Odense municipality, the family clinic (Familieambulatoriet), and local voluntary organizations.
The aim of the trial is to assess the effectiveness of FACAM to improve mother-child relationship, maternal health, maternal mental health, and the development and well-being of the child.
The study is a Randomized Controlled Trial (RCT). A total of 320 pregnant women will be randomized to FACAM or Care as Usual.
Participants are pregnant women categorized as antenatal care group 3 or 4, living in Odense and with a referral to Familieambulatoriet, OUH. Participants must be able to fill out questionnaires in Danish or English.
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)
盲法说明
As the participants are offered extra support as the intervention neither participants nor care providers can 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 women admitted to the Familieambulatorium, and living in Odense municipality
- •Antenatal care group 3 or 4 according to the Danish health authorities' recommendations
排除标准
- •Life-threatening illness in parent or child
- •Not able to fill out questionnaires in Danish or English
- •Child in out of home care after birth
- •Pregnancy with twins
- •Previous participation in the FACAM project
结局指标
主要结局
Maternal sensitivity
时间窗: at child age 12 months
Maternal sensitivity measured by the CIB (Coding Interactive Behavior)
次要结局
- Warwick-Edinburgh Mental Well-being Scale(child age 3 and 12 months)
- Experiences in Close Relationship Scale-Short Form (ECR-S)(Baseline)
- Maternal Sensitivity(at child age 3 months)
- Edinburgh Postnatal depression Scale (EPDS)(child age 3 and 12 months)
- Prenatal Parental reflective functioning questionnaire (P-PRFQ)(Baseline)
- Parental Stress Scale (PSS)(Cild age 3 and 12 months)
- Being a Mother (BAM-13)(child age 3 and 12 months)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, 3 and 12 months)
- Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)(child age 3 and 12 months)
- Parental reflective functioning questionnaire (PRFQ-1)(child age 12 months)
- Ages and Stages Questionnaire 3 (ASQ:3)(child age 3 months)
- Coding interactive bahavior (CIB)(child age 3 and 12 months)
- Activities with child(child age 12 months)