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

NCT05419167 | Completed Phase 1

• 1 other identifier: STEP COVID
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological; Mental Health Issue; Prenatal Stress; Maternal Distress; COVID-19 Pandemic

Keywords

Mentalization; Well-being; Pregnancy

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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

  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

  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

  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 Outcomes (12)

• Parental reflective functioning

  Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.

• Change in reflective functioning

  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

  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

  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

  Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of self-compassion.

Other Outcomes (1)

• Personality dysfunctions

  Administered at one time-point, at the second trimester of pregnancy. The measure will assess current level of personality dysfunctions.

Study Arms (2)

STEP-COVID

EXPERIMENTAL

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

Behavioral: STEP-COVID

Usual prenatal cares

NO INTERVENTION

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

Interventions

STEP-COVID BEHAVIORAL

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.

STEP-COVID

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Severe psychiatric disorders (schizophrenia, bipolar disorder)
• Severe emotional dysregulation
• Current self-harm
• Not sure to keep the child
• High level of hostility

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead
• Public Health Agency of Canada (PHAC): collaborator
• Canada Research Chairs Endowment of the Federal Government of Canada: collaborator

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A5H7, Canada

Location

Related Publications (1)

• Berthelot N, Garon-Bissonnette J, Drouin-Maziade C, Bergeron V, Series T. STEP-COVID: a pilot study of a prenatal intervention for pregnant women during the COVID-19 pandemic. Sci Rep. 2023 Apr 20;13(1):6466. doi: 10.1038/s41598-023-33369-8.

  PMID: 37081093 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 15, 2022
• Study Start: September 1, 2020
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2022
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)