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STEP for Maternal Distress (STEP Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Université du Québec à Trois-Rivières

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

STEP Trial Summary

This trial is testing a STEP program to see if it can help pregnant women who have experienced early life adversity to better regulate their emotions and to think more reflectively.

Eligible Conditions

Psychological Trauma
Prenatal Stress
Mental Health Issue
Maternal Distress

STEP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 trauma-specific reflective functioning

Level of satisfaction concerning the intervention

+3 more

Secondary outcome measures

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 anger 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 antenatal attachment

+14 more

Other outcome measures

Inflammation

Change in cortisol

Change in intimate partner violence

+1 more

STEP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: STEPExperimental Treatment1 Intervention

Participants will participate, online or in-person, to the 8-9 sessions of the program addressing the psychological experience of pregnancy and supporting reflective capacities in relation to trauma and motherhood.

Group II: Usual prenatal caresActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

STEP

2014

Completed Phase 3

~80

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Université du Québec à Trois-RivièresLead Sponsor

43 Previous Clinical Trials

4,323 Total Patients Enrolled

Public Health Agency of Canada (PHAC)OTHER_GOV

45 Previous Clinical Trials

97,023 Total Patients Enrolled

Canada Research Chairs Endowment of the Federal Government of CanadaOTHER_GOV

12 Previous Clinical Trials

176 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals is this experiment trying to accomplish?

"This research aims to evaluate the impact of maternal functioning over pregnant women's satisfaction, infant general development, motherly competence and parental bonding. Participants will be monitored from their second trimester up until 36-weeks gestation for a total duration that could reach seven months. The assessments conducted after each session and at the conclusion of the program shall quantify changes in perception while postpartum questionnaires on maternal competence and attachment are used to determine success with regards to these domains."

Answered by AI

Are any new participants being accepted at this time for the trial?

"Clinicaltrials.gov confirms that this medical study, which was first posted on June 15th 2018, is not actively recruiting at the moment. Despite this fact, 812 other clinical trials are currently looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Supporting the Transition to and Engagement in Parenthood

Nicolas Berthelot 2018. "Supporting the Transition to and Engagement in Parenthood". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04829864.