Clinical trial NCT04829864: Supporting the Transition to and Engagement in Parenthood
Official title: Phase 2 of STEP (Supporting the Transition to and Engagement in Parenthood): A Prenatal Intervention for Women Who Experienced Childhood Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Trauma, Psychological
Prenatal Stress
Mental Health Issue
Maternal Distress
Keywords: Mentalization
Maternal bonding
Trauma
Well-being
Attachment
Pregnancy
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
name: Social Sciences and Humanities Research Council of Canada
name: Canada Research Chairs Endowment of the Federal Government of Canada
First posted: 2021-04-02
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 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.
measure: Perception of change in domains of functioning during pregnancy
timeFrame: 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.
measure: Level of satisfaction concerning the intervention
timeFrame: 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.
measure: Prenatal reflective functioning
timeFrame: Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of reflective functions.
measure: Parental reflective functioning
timeFrame: Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
measure: Change in trauma-specific reflective functioning
timeFrame: 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.
measure: Change in trauma-specific reflective functioning
timeFrame: Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
Secondary outcomes:
measure: 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
timeFrame: 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.
measure: 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
timeFrame: 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.
measure: Change in perception of parental competence
timeFrame: 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.
measure: Change in antenatal attachment
timeFrame: 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.
measure: Self-compassion
timeFrame: Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of self-compassion.
measure: Connection to care
timeFrame: From the third trimester of pregnancy to 6 months postpartum. The assessment time frame thus covers a period of 7 months.
measure: Change in emotion regulation strategies
timeFrame: 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.
measure: Post-traumatic growth
timeFrame: Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of post-traumatic growth.
measure: Parental stress
timeFrame: Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of parental stress.
measure: Maternal bonding
timeFrame: Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of maternal bonding.
measure: Maternal competence
timeFrame: Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of perceived maternal competence..
measure: Depression
timeFrame: 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.
measure: Maternal behaviors
timeFrame: Administered at one time-point, around 12-months postpartum. The measure will assess current maternal behaviors..
measure: 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
timeFrame: 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.
measure: Infant general development
timeFrame: Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
measure: Infant socio-emotional development
timeFrame: Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
measure: Infant temperament
timeFrame: Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament
Other outcomes:
measure: Change in Inflammation
timeFrame: 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.
measure: Change in cortisol
timeFrame: 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.
measure: Personality dysfunctions
timeFrame: Administered at one time-point, at the second trimester of pregnancy. The measure will assess current level of personality dysfunctions.
measure: Change in intimate partner violence
timeFrame: 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.
Locations:
city: Québec
country: Canada
facility: Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre intégré de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
state: Quebec
Study officials:
References: