STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Post-traumatic growth
研究概览
简要总结
STEP-COVID (Supporting the Transition to and Engagement in Parenthood during the COVID-19 pandemic) is a manualized group intervention for pregnant women during the COVID-19 pandemic designed to foster emotion regulation and reflective capacities in participants.
详细描述
The program aims to (a) support mentalization in relation to oneself, motherhood and the relationship with the child to be born, (b) reduce isolation by allowing participants to exchange about the positive aspects and the challenges of pregnancy and motherhood with other women, (c) explore what pregnant women are going through in the context of the pandemic, (d) allow participants to repossess their experience of pregnancy in the current context of insecurity and fear, and (e) consider new ways of coping with stress and unpleasant emotions. The program is manualized and uses structured activities based on theoretical grounds and empirical research during which facilitators share information, animate reflective activities, and facilitate exchanges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women ages 18+ years
- •Interested in reflecting about their experience of pregnancy and willing to attend weekly sessions in group setting.
- •Must speak French as their first language
排除标准
- •Severe psychiatric disorders (schizophrenia, bipolar disorder)
- •Severe emotional dysregulation
- •Current self-harm
- •Not sure to keep the child
- •High level of hostility
结局指标
主要结局
Post-traumatic growth
时间窗: Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of post-traumatic growth.
Participants are invited to complete a self-report questionnaire of post-traumatic growth (Post-traumatic Growth Inventory) at the end of the third trimester of pregnancy. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.
Perception of change in domains of functioning during pregnancy
时间窗: Administered at one time-point, at the end of the third trimester of pregnancy. The participant will report on perceived changes during the last 9 months.
We developed an instrument assessing one's perception of change (negative change to positive change) across multiple domains of functioning including the quality of the relationship with the partner; the quality of the relationship with significant others, self-esteem; emotion recognition, regulation and expression; social support and parental confidence. These domains will be assessed separately.
Level of satisfaction concerning the intervention
时间窗: Satisfaction assessed after each session of the program and after its ending. Satisfaction is thus assessed between the second trimester of pregnancy and 36-weeks of pregnancy, for a total time frame up to 7-months.
Participants are invited to complete a self-report questionnaire assessing their level of satisfaction after each session and at the end of the program, using a Likert scale. A semi-structured interview is also administered at the end of the program that will provide qualitative information regarding their appreciation of the program.
Change in psychological distress from baseline (2nd trimester of pregnancy) to the end of the third trimester of pregnancy (around 36 weeks) and from baseline to 6-months postpartum
时间窗: Data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. The assessment time frame thus covers a period of 13 months.
Participants are invited to complete a self-report questionnaire (Kessler Distress Scale) assessing psychological distress. Change between baseline and end of pregnancy will be assessed, as well as between baseline and 6-month postpartum.
Change in affective states from baseline (2nd trimester of pregnancy) to the end of the third trimester of pregnancy (around 36 weeks) and from baseline to 6-months postpartum
时间窗: Data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. The assessment time frame thus covers a period of 13 months.
Participants are invited to complete a self-report questionnaire (Positive and Negative Affect Scale) assessing positive and negative affects. Change between baseline and end of pregnancy will be assessed as well as between baseline and 6-month postpartum.
次要结局
- Change in antenatal attachment(Data will be collected at recruitment (2nd trimester of pregnancy) and at 36-weeks of pregnancy. The assessment time frame thus covers a period of 7 months.)
- Parental reflective functioning(Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.)
- Self-compassion(Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of self-compassion.)
- Maternal bonding(Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of maternal bonding.)
- Change in perception of parental competence(Data will be collected at recruitment (2nd trimester of pregnancy) and at 36-weeks of pregnancy. The assessment time frame thus covers a period of 7 months.)
- Connection to care(From the third trimester of pregnancy to 6 months postpartum. The assessment time frame thus covers a period of 7 months.)
- Infant general development(Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.)
- Change in reflective functioning(Data will be collected at recruitment (2nd trimester of pregnancy), at 36-weeks of pregnancy and at 6-months postnatal. The assessment time frame thus covers a period of 13 months.)
- Change in emotion regulation strategies(Data will be collected at recruitment (2nd trimester of pregnancy) and at 36-weeks of pregnancy. he assessment time frame thus covers a period of 7 months.)
- Parental stress(Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of parental stress.)
- Infant temperament(Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament)
- Infant socio-emotional development(Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.)
研究者
Nicolas Berthelot
Full professor
Université du Québec à Trois-Rivières