Phase 2 of STEP (Supporting the Transition to and Engagement in Parenthood): A Prenatal Intervention for Women Who Experienced Childhood Trauma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Parental reflective functioning
研究概览
简要总结
STEP (Supporting the Transition to and Engagement in Parenthood) is a manualized group intervention for pregnant women exposed to early life adversity designed to foster emotion regulation and reflective capacities in participants.
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 —（Adult, Older 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
Parental reflective functioning
时间窗: Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
Participants will complete the Parental Reflective Functioning Questionnaire at 6 months postpartum. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.
Change in trauma-specific reflective functioning
时间窗: Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
Participants will participate to the Trauma Meaning Making Interview (TMMI) at 6-months postnatal. The interview will be subsequently coded for trauma-specific reflective functioning. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.
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,
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.
Prenatal reflective functioning
时间窗: Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of reflective functions.
Participants will complete the Pregnancy Interview at the end of the third trimester of pregnancy. The interview will be subsequently coded for prenatal reflective functioning. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.
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.
次要结局
- Infant general development(Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.)
- Post-traumatic growth(Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of post-traumatic growth.)
- Parental stress(Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of parental stress.)
- Change in anger 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(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 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.)
- 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(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.)
- Infant socio-emotional development(Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.)
- Change in post-traumatic stress symptoms 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(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 antenatal attachment(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.)
- 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.)
- Connection to care(From the third trimester of pregnancy to 6 months postpartum. The assessment time frame thus covers a period of 7 months.)
- Maternal bonding(Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of maternal bonding.)
- Maternal competence(Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of perceived maternal competence..)
- Maternal behaviors(Administered at one time-point, around 12-months postpartum. The measure will assess current maternal behaviors..)
- 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.)
- Depression(Data will be collected at 36-weeks of pregnancy and at 6-months postpartum. The assessment time frame thus covers a period of 7 months.)
- Infant temperament(Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament)
研究者
Nicolas Berthelot
Professor
Université du Québec à Trois-Rivières