Supporting the Transition to and Engagement in Parenthood

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 of STEP (Supporting the Transition to and Engagement in Parenthood): A Prenatal Intervention for Women Who Experienced Childhood Trauma

Conditions
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Mental Health Issue, Trauma, Psychological, Prenatal Stress, Maternal Distress

Intervention / Treatment
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* Behavioral: STEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Severe psychiatric disorders (schizophrenia, bipolar disorder) Severe emotional dysregulation Current self-harm Not sure to keep the child High level of hostility

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEP<br>Participants will participate, online or in-person, to the 8-9 sessions of the program addressing the psychological experience of pregnancy and supporting reflective capacities in relation to trauma and motherhood. | Behavioral: STEP<br>* The program is offered by two facilitators to groups of three to seven women, in-person or online. The program is divided in three phases entitles Becoming a mother; A look at my own history and Looking ahead. The first phase aims to explore and normalize the emotions experienced by the participants in the course of their pregnancy and to support the use of healthy emotion regulation strategies. The second phase aims to support mentalization of trauma, by discussing the nature of trauma and its impact; by validating participants' feelings as understandable responses to trauma; by supporting a reflection on positive and harsh experiences with significant others and the ways both types of experiences influenced participants' mental states; and identifying how participants coped with trauma. In the last phase, discussions focus on participants' needs and strengths, on available resources to support resilience and envision positive and challenging moments with the child.<br>|
| No Intervention: Usual prenatal cares<br>Participants of the comparison group will receive usual prenatal cares (ex. prenatal classes) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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, | 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. | 
| Perception of change in domains of functioning during pregnancy | 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. | 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. | 
| Level of satisfaction concerning the intervention | 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. | 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. | 
| Prenatal reflective functioning | 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. | Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of reflective functions. | 
| Parental reflective functioning | 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. | Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions. | 
| Change in trauma-specific reflective functioning | The Failure to mentalize trauma questionnaire (FMTQ) will be administered at baseline, at the end of the third trimester of pregnancy and at 6-months postpartum. Change between time-points will be assessed. | 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 trauma-specific reflective functioning | 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. | Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Participants are invited to complete a self-report questionnaire of PTSD symptoms (Post-traumatic checklist for DSM-5). Change between baseline and the end of pregnancy will be assessed as well as between baseline and 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 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 | Participants are invited to complete a self-report questionnaire of anger states (STAXI). Change between baseline and the end of pregnancy will be assessed as well as between baseline and 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 | Participants are invited to complete a self-report questionnaire of maternal confidence (Maternal confidence questionnaire). Change between baseline and the end of pregnancy will be assessed. | 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 antenatal attachment | Participants are invited to complete a self-report questionnaire of antenatal attachment (Maternal antenatal attachment scale). Change between baseline and the end of pregnancy will be assessed. | 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 | Participants are invited to complete a self-report questionnaire of self-compassion 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. | 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 | Participants will be referred to community agencies for resources based on need during their participation to STEP. Their utilization of other resources will be assessed using self-reported questionnaires at the end of the third trimester of pregnancy and at 6 months postpartum | From the third trimester of pregnancy to 6 months postpartum. The assessment time frame thus covers a period of 7 months. | 
| Change in emotion regulation strategies | Participants are invited to complete a self-report questionnaire of emotion regulation strategies (CERQ). Change between baseline and the end of pregnancy, as well as between baseline and 6 months postpartum will be assessed. | 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. | 
| Post-traumatic growth | Participants are invited to complete a self-report questionnaire of post-traumatic growth 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. | 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 | Participants are invited to complete a self-report questionnaire of parental stress 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. | Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of parental stress. | 
| Maternal bonding | Participants are invited to complete a self-report questionnaire of maternal bonding 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. | Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of maternal bonding. | 
| Maternal competence | Participants are invited to complete a self-report questionnaire of maternal sense of competence 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. | Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of perceived maternal competence.. | 
| Depression | Participants are invited to complete a self-report questionnaire of post-partum depression at the end of the third trimester of pregnancy and 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 separately for each time point. | 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. | 
| Maternal behaviors | Mother-infant interactions will be realized and videotaped for subsequent coding of maternal behaviors around 12-months postpartum. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention | Administered at one time-point, around 12-months postpartum. The measure will assess current maternal behaviors.. | 
| 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 | 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, | 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 general development | The ASQ-3 will be administered at 6-months postnatal to assess infant development. | Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development. | 
| Infant socio-emotional development | The ASQ-SE will be administered at 6-months postnatal to assess infant socio-emotional development. | Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development. | 
| Infant temperament | The IBQ will be administered at 6-months postnatal to assess infant temperament | Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mentalization, Maternal bonding, Trauma, Well-being, Attachment, Pregnancy