- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05419167
STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic
June 14, 2022 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
Active, not recruiting
Intervention / Treatment
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
Interventional
Enrollment (Actual)
100
Phase
- 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
-
-
Quebec
-
Trois-Rivières, Quebec, Canada, G9A5H7
- Université du Québec à Trois-Rivières
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
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 |
Intervention / Treatment |
---|---|
Experimental: STEP-COVID
Participants will participate online to the 6 sessions of the program addressing the psychological experience of pregnancy and supporting reflective capacities.
|
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
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
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
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.
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)
September 1, 2020
Primary Completion (Actual)
December 10, 2021
Study Completion (Anticipated)
December 10, 2022
Study Registration Dates
First Submitted
June 13, 2022
First Submitted That Met QC Criteria
June 13, 2022
First Posted (Actual)
June 15, 2022
Study Record Updates
Last Update Posted (Actual)
June 21, 2022
Last Update Submitted That Met QC Criteria
June 14, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on COVID-19 Pandemic
-
Laval UniversityCISSS de Chaudière-Appalaches; VITAM: Research Center on Sustainable Health; Centre... and other collaboratorsRecruiting
-
Assiut UniversityDoaa M.EL ShehabyUnknownCovid 19 Pandemic From Ethical View
-
University of JordanAysha Alkhayat; Mariam Aljweesri; Reem Alharbi; Zahraa AljazzafCompleted
-
Sialkott College of Physical TherapyCompletedBurnout, Psychological | Covid-19 PandemicPakistan
-
Charite University, Berlin, GermanyRecruitingAnxiety Related to the COVID-19 PandemicGermany
-
University Hospital, BrestCompletedIdentify Emerging Health Challenges for Children With Motor Disabilities and Their Parents Facing the COVID-19 PandemicFrance
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
Hospices Civils de LyonCompletedEmergency Department Staff During the COVID-19 Pandemic | Emergency Department Staff's Level of StressFrance
-
University of PadovaNorthwell Health; Donald and Barbara Zucker School of Medicine at Hofstra/NorthwellUnknownMental Health Wellness 1 | PandemicGreece
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 VaccinesIndonesia
Clinical Trials on STEP-COVID
-
Northwestern UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...Completed
-
Reuth Rehabilitation HospitalCompletedAcquired Brain InjuryIsrael
-
Friends Research Institute, Inc.Baylor College of Medicine; Children's Hospital of Philadelphia; San Diego State... and other collaboratorsCompleted
-
Pro-Change Behavior SystemsCompletedSmoking Cessation | Poor Nutrition | Life Stress
-
Region StockholmKarolinska InstitutetActive, not recruiting
-
Karolinska InstitutetVastra Gotaland Region; Region StockholmNot yet recruiting
-
Taisho Pharmaceutical Co., Ltd.CompletedHealthy VolunteerJapan
-
Rush University Medical CenterUniversity of Illinois at Chicago; Michigan State UniversityActive, not recruitingPhysical ActivityUnited States
-
University Hospital, MontpellierDirection Générale de l'Offre de SoinsNot yet recruitingNeurodevelopmental Disorders | Autism Spectrum Disorder | SiblingsFrance
-
VU University of AmsterdamFreie Universität Berlin; World Health Organization; Ministry of Public Health...Completed