search
Back to results

STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic

Primary Purpose

Psychological, Mental Health Issue, Prenatal Stress

Status
Active
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
STEP-COVID
Sponsored by
Université du Québec à Trois-Rivières
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychological focused on measuring Mentalization, Well-being, Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Université du Québec à Trois-Rivières

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

STEP-COVID

Usual prenatal cares

Arm Description

Participants will participate online to the 6 sessions of the program addressing the psychological experience of pregnancy and supporting reflective capacities.

Participants of the comparison group will receive usual prenatal cares (ex. prenatal classes)

Outcomes

Primary Outcome Measures

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.
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.
Post-traumatic growth
Participants are invited to complete a self-report questionnaire of post-traumatic growth (Post-traumatic Growth Inventory) 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.
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.
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.

Secondary Outcome Measures

Parental reflective functioning
Participants will complete the Parental Reflective Functioning Questionnaire (PRFQ) 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 reflective functioning
The Reflective Functioning Questionnaire (RFQ-8) 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.
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.
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.
Self-compassion
Participants are invited to complete a self-report questionnaire of self-compassion (Self-Compassion Scale) 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
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.
Change in emotion regulation strategies
Participants are invited to complete a self-report questionnaire of emotion regulation strategies (Cognitive Emotion Regulation Questionnaire). Change between baseline and the end of pregnancy, as well as between baseline and 6 months postpartum will be assessed.
Parental stress
Participants are invited to complete a self-report questionnaire of parental stress (Parenting Stress Index) 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 bonding
Participants are invited to complete a self-report questionnaire of maternal bonding (Maternal postnatal attachment scale) 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.
Infant general development
The Age and Stage Questionnaire Third Edition (ASQ-3) will be administered at 6-months postnatal to assess infant development.
Infant socio-emotional development
The Ages & Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2) will be administered at 6-months postnatal to assess infant socio-emotional development.
Infant temperament
The Infant Behavior Questionnaire (IBQ) will be administered at 6-months postnatal to assess infant temperament

Full Information

First Posted
June 13, 2022
Last Updated
June 14, 2022
Sponsor
Université du Québec à Trois-Rivières
Collaborators
Public Health Agency of Canada (PHAC), Canada Research Chairs Endowment of the Federal Government of Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT05419167
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
December 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université du Québec à Trois-Rivières
Collaborators
Public Health Agency of Canada (PHAC), Canada Research Chairs Endowment of the Federal Government of Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological, Mental Health Issue, Prenatal Stress, Maternal Distress, COVID-19 Pandemic
Keywords
Mentalization, Well-being, Pregnancy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STEP-COVID
Arm Type
Experimental
Arm Description
Participants will participate online to the 6 sessions of the program addressing the psychological experience of pregnancy and supporting reflective capacities.
Arm Title
Usual prenatal cares
Arm Type
No Intervention
Arm Description
Participants of the comparison group will receive usual prenatal cares (ex. prenatal classes)
Intervention Type
Behavioral
Intervention Name(s)
STEP-COVID
Intervention Description
The program is offered by two facilitators to groups of three to six women, online in a synchronous mode. The intervention is divided into two phases, each including three sessions. The first 3 sessions aim to explore how the participants feel, to better understand what makes them feel this way, to allow them to exchange with other people who are going through similar experiences, and to support the ability to manage stress and more unpleasant emotions. The following three sessions aim to enable participants to refocus on their experience of pregnancy and motherhood by giving them the opportunity to reflect upon how they wish to be as mothers, upon how their personal history influences their experience of pregnancy and motherhood, upon the moments that, as mothers, might be the most pleasant and those that will require more adaptations, and upon identifying the needs they have or expect to have after childbirth as well as the resources available to them to meet these needs.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
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.
Title
Perception of change in domains of functioning during pregnancy
Description
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.
Time Frame
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.
Title
Post-traumatic growth
Description
Participants are invited to complete a self-report questionnaire of post-traumatic growth (Post-traumatic Growth Inventory) 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.
Time Frame
Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of post-traumatic growth.
Title
Level of satisfaction concerning the intervention
Description
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.
Time Frame
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.
Title
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
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Parental reflective functioning
Description
Participants will complete the Parental Reflective Functioning Questionnaire (PRFQ) 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.
Time Frame
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
Title
Change in reflective functioning
Description
The Reflective Functioning Questionnaire (RFQ-8) 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.
Time Frame
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.
Title
Change in perception of parental competence
Description
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.
Time Frame
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.
Title
Change in antenatal attachment
Description
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.
Time Frame
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.
Title
Self-compassion
Description
Participants are invited to complete a self-report questionnaire of self-compassion (Self-Compassion Scale) 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.
Time Frame
Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of self-compassion.
Title
Connection to care
Description
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.
Time Frame
From the third trimester of pregnancy to 6 months postpartum. The assessment time frame thus covers a period of 7 months.
Title
Change in emotion regulation strategies
Description
Participants are invited to complete a self-report questionnaire of emotion regulation strategies (Cognitive Emotion Regulation Questionnaire). Change between baseline and the end of pregnancy, as well as between baseline and 6 months postpartum will be assessed.
Time Frame
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.
Title
Parental stress
Description
Participants are invited to complete a self-report questionnaire of parental stress (Parenting Stress Index) 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.
Time Frame
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of parental stress.
Title
Maternal bonding
Description
Participants are invited to complete a self-report questionnaire of maternal bonding (Maternal postnatal attachment scale) 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.
Time Frame
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of maternal bonding.
Title
Infant general development
Description
The Age and Stage Questionnaire Third Edition (ASQ-3) will be administered at 6-months postnatal to assess infant development.
Time Frame
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
Title
Infant socio-emotional development
Description
The Ages & Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2) will be administered at 6-months postnatal to assess infant socio-emotional development.
Time Frame
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
Title
Infant temperament
Description
The Infant Behavior Questionnaire (IBQ) will be administered at 6-months postnatal to assess infant temperament
Time Frame
Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament
Other Pre-specified Outcome Measures:
Title
Personality dysfunctions
Description
Personality dysfunctions are assessed at baseline and will be considered as a moderator of the intervention effectiveness. Personality dysfunctions will be measured using the Self and Interpersonal Functioning Rating Scale, a 24-item self-report questionnaire designed to assess the four core elements of personality pathology (Identity, Self-direction, Empathy, and Intimacy) from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Level of Personality Functioning for personality disorders.
Time Frame
Administered at one time-point, at the second trimester of pregnancy. The measure will assess current level of personality dysfunctions.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Université du Québec à Trois-Rivières
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G9A5H7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic

We'll reach out to this number within 24 hrs