STEP-COVID for Fetal Distress

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Université du Québec à Trois-Rivières, Trois-Rivières, Canada
Fetal Distress+7 More
STEP-COVID - Behavioral
Eligibility
18+
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Fetal Distress
  • COVID-19 Pandemics
  • Psychological
  • Mental Health Issue
  • Prenatal Stress

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 12 Secondary · Reporting Duration: 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.

Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
Infant general development
Infant socio-emotional development
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
Parental reflective functioning
Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament
Infant temperament
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of maternal bonding.
Maternal bonding
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of parental stress.
Parental stress
Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of post-traumatic growth.
Post-traumatic growth
Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of self-compassion.
Self-compassion
Month 9
Perception of change in domains of functioning during pregnancy
Administered at one time-point, at the second trimester of pregnancy. The measure will assess current level of personality dysfunctions.
Personality dysfunctions
Month 7
Change in antenatal attachment
Change in perception of parental competence
Month 7
Change in emotion regulation strategies
Month 13
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
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
Change in reflective functioning
Month 7
Connection to care
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.
Level of satisfaction concerning the intervention

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Usual prenatal cares
1 of 2
STEP-COVID
1 of 2
Active Control
Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: STEP-COVID · No Placebo Group · Phase 1

STEP-COVID
Behavioral
Experimental Group · 1 Intervention: STEP-COVID · Intervention Types: Behavioral
Usual prenatal caresNoIntervention Group · 1 Intervention: Usual prenatal cares · Intervention Types:

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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.
Closest Location: Université du Québec à Trois-Rivières · Trois-Rivières, Canada
Photo of quebec 1Photo of quebec 2Photo of quebec 3
2008First Recorded Clinical Trial
0 TrialsResearching Fetal Distress
13 CompletedClinical Trials

Who is running the clinical trial?

Public Health Agency of Canada (PHAC)OTHER_GOV
38 Previous Clinical Trials
88,559 Total Patients Enrolled
Canada Research Chairs Endowment of the Federal Government of CanadaOTHER_GOV
12 Previous Clinical Trials
186 Total Patients Enrolled
Université du Québec à Trois-RivièresLead Sponsor
34 Previous Clinical Trials
3,727 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are interested in reflecting about your experience of pregnancy and willing to attend weekly sessions in group setting.
You must speak French as your first language.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.