MAMA NO STRESS Project. The Effects of the "HAPPY MAMA" Intervention: a Field Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 主要终点
- Assessing a change of the Parental Stress Scale (PSS): The main outcome measures are the Parental Stress Scale (PSS) for change between the baseline and the follow-up (four time points).
研究概览
简要总结
This study evaluates the effects of a postpartum intervention in increasing the maternal well-being and self-efficacy of Italian women in the first one to six months after childbirth, as well as in reducing postpartum depression and stress.
The intervention will use the motivational interviewing against high levels of daily stress. One third of participants will be exposed to a 3,5 hours group intervention approximately 1 month after delivery, one third will be exposed to an individual intervention in the same period and one third will receive no intervention. Participants will be followed with stress and depression questionnaires.
详细描述
Aim
The aim of this study is to assess the effectiveness of an intervention, called "HAPPY MAMA", in reducing postpartum stress level, increasing the parenting self-efficacy and the maternal well-being of Italian women in the first one to six months after childbirth.
Design of the study
The study will be an experimental pilot field trial. The present research will be a multi-centric study to be conducted in three different hospitals in Rome. The CONSORT statement will be followed to perform the research.
Eligibility criteria for participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •The following eligibility criteria will be applied:
- •Participant must be a woman aged 18 years old or older;
- •Participant must be able to communicate in Italian.
- •They following
排除标准
- •will be applied:
- •women will be excluded from the study if they or their babies have serious health problems;
- •the baby was born at <37 weeks gestation, weighed <2500 g;
- •the baby has the APGAR score <7 immediately after birth (17).
研究组 & 干预措施
Collective Intervention "G"
HAPPY MAMA intervention will follow the following steps: listening and establishing relationship phases; analysis of the problems; definition of the problem and the goal of intervention.
The duration will be of 3.5 hours in one day and the intervention will happen in "Sapienza" University of Rome, in a group of 15 women.
This group fill in an on line questtionarie for four times, the first before the intervention.
干预措施: Collective Intervention "G" (Behavioral)
Individual Intervention "I"
The same intervention of "G" group (HAPPY MAMA), but at individual level and the intervention will happen at the participants' house.
This group fill in an on line questtionarie for four times, the first before the intervention.
干预措施: Individual Intervention "I" (Behavioral)
Control group "C"
The women from this group will not receive any intervention. This group fill in an on-line questtionarie for four times.
结局指标
主要结局
Assessing a change of the Parental Stress Scale (PSS): The main outcome measures are the Parental Stress Scale (PSS) for change between the baseline and the follow-up (four time points).
时间窗: 4 weeks after the delivery or 2/3 days before the intervention; 2 months after delivery or 2 weeks after the intervention; 3 months after delivery; 6ths after delivery.
The PSS scale consisted of 18 items rated on a 5-point Likert scale. The total score was obtained by summing up the value for each item. A higher score indicates a higher level of parental stress. An Italian version of the questionnaire will be used. A follow-up of the PSS score will be computed.
次要结局
- Assessing a change of the Karitane Parenting Confidence Scale (KPCS). The secondary outcome measures are theKaritane Parenting Confidence Scale (KPCS) for change between the baseline and the follow-up (four time points).(4 weeks after delivery or 2/3 days before the intervention; 2 months after delivery or 2 weeks after the intervention; 3 months after delivery; 6 months after delivery.)
- Assessing a change of the Edinburgh Postnatal Depression Scale (EPDS). The secondary outcome measures are the Edinburgh Postnatal Depression Scale (EPDS) for change between the baseline and the follow-up (four time points).(4 weeks after delivery or 2/3 days before the intervention; 2 months after delivery or 2 weeks after the intervention; 3 months after delivery; 6 months after delivery.)
研究者
Giuseppe La Torre
Professor
University of Roma La Sapienza