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

Phase 1

Completed

• Conditions: Maternal Distress; Mental Health Issue; COVID-19 Pandemic; Prenatal Stress; Psychological
• Interventions: Behavioral: STEP-COVID

• Registration Number: NCT05419167
• Lead Sponsor: Université du Québec à Trois-Rivières

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.

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-12-10
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-15
• Study Completion: 2022-12-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STEP-COVID	STEP-COVID	Participants will participate online to the 6 sessions of the program addressing the psychological experience of pregnancy and supporting reflective capacities.

Primary Outcome Measures

Name	Time	Method
Post-traumatic growth	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.
Perception of change in domains of functioning during pregnancy	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.
Level of satisfaction concerning the intervention	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.
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	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.
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	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.
Parental reflective functioning	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.
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.	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.
Maternal bonding	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.
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.	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.
Connection to care	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.
Infant general development	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.
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.	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 emotion regulation strategies	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.
Parental stress	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.
Infant temperament	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
Infant socio-emotional development	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.

Trial Locations

Locations (1)

Université du Québec à Trois-Rivières; 🇨🇦 Trois-Rivières, Quebec, Canada