Clinical trial NCT05419167: STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic
Official title: STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psychological
Mental Health Issue
Prenatal Stress
Maternal Distress
COVID-19 Pandemic
Keywords: Mentalization
Well-being
Pregnancy
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
name: Canada Research Chairs Endowment of the Federal Government of Canada
First posted: 2022-06-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

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: 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: 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: 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.
Secondary outcomes:
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 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 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. The 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: 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: 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: Personality dysfunctions
timeFrame: Administered at one time-point, at the second trimester of pregnancy. The measure will assess current level of personality dysfunctions.
Locations:
city: Trois-Rivières
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
References: