Supporting the Transition to and Engagement in Parenthood
- Conditions
- Trauma, PsychologicalPrenatal StressMaternal DistressMental Health Issue
- Interventions
- Behavioral: STEP
- Registration Number
- NCT04829864
- Lead Sponsor
- Université du Québec à Trois-Rivières
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 110
- 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
- Severe psychiatric disorders (schizophrenia, bipolar disorder)
- Severe emotional dysregulation
- Current self-harm
- Not sure to keep the child
- High level of hostility
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description STEP STEP 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.
- Primary Outcome Measures
Name Time Method Parental reflective functioning 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 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method 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. 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.
Infant general development Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development. The ASQ-3 will be administered at 6-months postnatal to assess infant development.
Parental stress Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of 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.
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. 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
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. 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.
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. 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,
Infant socio-emotional development Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development. The ASQ-SE will be administered at 6-months postnatal to assess infant socio-emotional 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. 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
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. 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.
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. 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.
Connection to care From the third trimester of pregnancy to 6 months postpartum. The assessment time frame thus covers a period of 7 months. 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
Maternal bonding Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of 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.
Maternal competence Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of perceived 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.
Maternal behaviors Administered at one time-point, around 12-months postpartum. The measure will assess current 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
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. 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.
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. 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.
Infant temperament Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament The IBQ will be administered at 6-months postnatal to assess infant temperament
Trial Locations
- Locations (2)
Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
🇨🇦Québec, Quebec, Canada
Centre intégré de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
🇨🇦Trois-Rivières, Quebec, Canada