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

NCT ID: NCT05419167

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-12-10

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

STEP-COVID

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

Group Type: EXPERIMENTAL

STEP-COVID

Intervention Type: 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.

Usual prenatal cares

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role: collaborator

Canada Research Chairs Endowment of the Federal Government of Canada

OTHER_GOV

Sponsor Role: collaborator

Université du Québec à Trois-Rivières

OTHER

Sponsor Role: lead

Responsible Party

Nicolas Berthelot

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 37081093 (View on PubMed)

Other Identifiers

STEP COVID

Identifier Type: -

Identifier Source: org_study_id