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

July 8, 2024 updated by: Nicolas Berthelot, Université du Québec à Trois-Rivières
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Trois-Rivières, Quebec, Canada, G9A5H7
        • Universite du Quebec à Trois-Rivieres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: STEP-COVID
Participants will participate online to the 6 sessions of the program addressing the psychological experience of pregnancy and supporting reflective capacities.
Behavioral: STEP-COVID
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.
No Intervention: Usual prenatal cares
Participants of the comparison group will receive usual prenatal cares (ex. prenatal classes)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
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
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.
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.
Post-traumatic growth
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.
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.
Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of post-traumatic growth.
Level of satisfaction concerning the intervention
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.
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.
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
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.
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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parental reflective functioning
Time Frame: 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 (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.
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
Change in reflective functioning
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.
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.
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
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.
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
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.
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. The assessment time frame thus covers a period of 7 months.
Self-compassion
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.
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.
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
Time Frame: 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.
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
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.
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.
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.
Parental stress
Time Frame: 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 (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.
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of parental stress.
Maternal bonding
Time Frame: 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 (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.
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of maternal bonding.
Infant general development
Time Frame: Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
The Age and Stage Questionnaire Third Edition (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
Time Frame: Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant 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.
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
Infant temperament
Time Frame: Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament
The Infant Behavior Questionnaire (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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Personality dysfunctions
Time Frame: Administered at one time-point, at the second trimester of pregnancy. The measure will assess current level of personality dysfunctions.
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.
Administered at one time-point, at the second trimester of pregnancy. The measure will assess current level of personality dysfunctions.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université du Québec à Trois-Rivières

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Public Health Agency of Canada (PHAC)
Canada Research Chairs Endowment of the Federal Government of Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STEP COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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