Supporting the Transition to and Engagement in Parenthood (STEP)
Primary Purpose
Trauma, Psychological, Prenatal Stress, Mental Health Issue
Status
Active
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
STEP
Sponsored by
About this trial
This is an interventional supportive care trial for Trauma, Psychological focused on measuring Mentalization, Maternal bonding, Trauma, Well-being, Attachment, Pregnancy
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
Sites / Locations
- Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
- Centre intégré de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
STEP
Usual prenatal cares
Arm Description
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.
Participants of the comparison group will receive usual prenatal cares (ex. prenatal classes)
Outcomes
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
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,
Perception of change in domains of functioning during pregnancy
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
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.
Prenatal reflective functioning
Participants will complete the Pregnancy Interview at the end of the third trimester of pregnancy. The interview will be subsequently coded for prenatal reflective functioning. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.
Parental reflective functioning
Participants will complete the Parental Reflective Functioning Questionnaire 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 trauma-specific reflective functioning
The Failure to mentalize trauma questionnaire (FMTQ) 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 trauma-specific reflective functioning
Participants will participate to the Trauma Meaning Making Interview (TMMI) at 6-months postnatal. The interview will be subsequently coded for trauma-specific reflective functioning. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.
Secondary Outcome Measures
Change in post-traumatic stress symptoms 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
Participants are invited to complete a self-report questionnaire of PTSD symptoms (Post-traumatic checklist for DSM-5). Change between baseline and the end of pregnancy will be assessed as well as between baseline and 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
Participants are invited to complete a self-report questionnaire of anger states (STAXI). Change between baseline and the end of pregnancy will be assessed as well as between baseline and 6-months postpartum
Change in perception of parental competence
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.
Change in antenatal attachment
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.
Self-compassion
Participants are invited to complete a self-report questionnaire of self-compassion 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.
Connection to care
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
Change in emotion regulation strategies
Participants are invited to complete a self-report questionnaire of emotion regulation strategies (CERQ). Change between baseline and the end of pregnancy, as well as between baseline and 6 months postpartum will be assessed.
Post-traumatic growth
Participants are invited to complete a self-report questionnaire of post-traumatic growth 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.
Parental stress
Participants are invited to complete a self-report questionnaire of parental stress 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.
Maternal bonding
Participants are invited to complete a self-report questionnaire of maternal bonding 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.
Maternal competence
Participants are invited to complete a self-report questionnaire of maternal sense of competence 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.
Depression
Participants are invited to complete a self-report questionnaire of post-partum depression at the end of the third trimester of pregnancy and 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 separately for each time point.
Maternal behaviors
Mother-infant interactions will be realized and videotaped for subsequent coding of maternal behaviors around 12-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 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
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,
Infant general development
The ASQ-3 will be administered at 6-months postnatal to assess infant development.
Infant socio-emotional development
The ASQ-SE will be administered at 6-months postnatal to assess infant socio-emotional development.
Infant temperament
The IBQ will be administered at 6-months postnatal to assess infant temperament
Full Information
NCT ID
NCT04829864
First Posted
March 4, 2021
Last Updated
June 13, 2022
Sponsor
Université du Québec à Trois-Rivières
Collaborators
Public Health Agency of Canada (PHAC), Social Sciences and Humanities Research Council of Canada, Canada Research Chairs Endowment of the Federal Government of Canada
1. Study Identification
Unique Protocol Identification Number
NCT04829864
Brief Title
Supporting the Transition to and Engagement in Parenthood
Acronym
STEP
Official Title
Phase 2 of STEP (Supporting the Transition to and Engagement in Parenthood): A Prenatal Intervention for Women Who Experienced Childhood Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
May 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université du Québec à Trois-Rivières
Collaborators
Public Health Agency of Canada (PHAC), Social Sciences and Humanities Research Council of Canada, Canada Research Chairs Endowment of the Federal Government of Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
STEP (Supporting the Transition to and Engagement in Parenthood) is a manualized group intervention for pregnant women exposed to early life adversity designed to foster emotion regulation and reflective capacities in participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Psychological, Prenatal Stress, Mental Health Issue, Maternal Distress
Keywords
Mentalization, Maternal bonding, Trauma, Well-being, Attachment, Pregnancy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STEP
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual prenatal cares
Arm Type
No Intervention
Arm Description
Participants of the comparison group will receive usual prenatal cares (ex. prenatal classes)
Intervention Type
Behavioral
Intervention Name(s)
STEP
Intervention Description
The program is offered by two facilitators to groups of three to seven women, in-person or online. The program is divided in three phases entitles "Becoming a mother"; "A look at my own history" and "Looking ahead". The first phase aims to explore and normalize the emotions experienced by the participants in the course of their pregnancy and to support the use of healthy emotion regulation strategies. The second phase aims to support mentalization of trauma, by discussing the nature of trauma and its impact; by validating participants' feelings as understandable responses to trauma; by supporting a reflection on positive and harsh experiences with significant others and the ways both types of experiences influenced participants' mental states; and identifying how participants coped with trauma. In the last phase, discussions focus on participants' needs and strengths, on available resources to support resilience and envision positive and challenging moments with the child.
Primary Outcome Measure Information:
Title
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
Description
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,
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.
Title
Perception of change in domains of functioning during pregnancy
Description
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.
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.
Title
Level of satisfaction concerning the intervention
Description
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.
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.
Title
Prenatal reflective functioning
Description
Participants will complete the Pregnancy Interview at the end of the third trimester of pregnancy. The interview will be subsequently coded for prenatal reflective functioning. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.
Time Frame
Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of reflective functions.
Title
Parental reflective functioning
Description
Participants will complete the Parental Reflective Functioning Questionnaire 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.
Time Frame
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
Title
Change in trauma-specific reflective functioning
Description
The Failure to mentalize trauma questionnaire (FMTQ) 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.
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.
Title
Change in trauma-specific reflective functioning
Description
Participants will participate to the Trauma Meaning Making Interview (TMMI) at 6-months postnatal. The interview will be subsequently coded for trauma-specific reflective functioning. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention.
Time Frame
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
Secondary Outcome Measure Information:
Title
Change in post-traumatic stress symptoms 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
Description
Participants are invited to complete a self-report questionnaire of PTSD symptoms (Post-traumatic checklist for DSM-5). Change between baseline and the end of pregnancy will be assessed as well as between baseline and 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.
Title
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
Description
Participants are invited to complete a self-report questionnaire of anger states (STAXI). Change between baseline and the end of pregnancy will be assessed as well as between baseline and 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.
Title
Change in perception of parental competence
Description
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.
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.
Title
Change in antenatal attachment
Description
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.
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.
Title
Self-compassion
Description
Participants are invited to complete a self-report questionnaire of self-compassion 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.
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.
Title
Connection to care
Description
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
Time Frame
From the third trimester of pregnancy to 6 months postpartum. The assessment time frame thus covers a period of 7 months.
Title
Change in emotion regulation strategies
Description
Participants are invited to complete a self-report questionnaire of emotion regulation strategies (CERQ). Change between baseline and the end of pregnancy, as well as between baseline and 6 months postpartum will be assessed.
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.
Title
Post-traumatic growth
Description
Participants are invited to complete a self-report questionnaire of post-traumatic growth 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.
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.
Title
Parental stress
Description
Participants are invited to complete a self-report questionnaire of parental stress 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.
Time Frame
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of parental stress.
Title
Maternal bonding
Description
Participants are invited to complete a self-report questionnaire of maternal bonding 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.
Time Frame
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of maternal bonding.
Title
Maternal competence
Description
Participants are invited to complete a self-report questionnaire of maternal sense of competence 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.
Time Frame
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of perceived maternal competence..
Title
Depression
Description
Participants are invited to complete a self-report questionnaire of post-partum depression at the end of the third trimester of pregnancy and 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 separately for each time point.
Time Frame
Data will be collected at 36-weeks of pregnancy and at 6-months postpartum. The assessment time frame thus covers a period of 7 months.
Title
Maternal behaviors
Description
Mother-infant interactions will be realized and videotaped for subsequent coding of maternal behaviors around 12-months postpartum. Scores in participants to the intervention will be compared to scores of matched controls who did not participate to the intervention
Time Frame
Administered at one time-point, around 12-months postpartum. The measure will assess current maternal behaviors..
Title
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
Description
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,
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.
Title
Infant general development
Description
The ASQ-3 will be administered at 6-months postnatal to assess infant development.
Time Frame
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
Title
Infant socio-emotional development
Description
The ASQ-SE will be administered at 6-months postnatal to assess infant socio-emotional development.
Time Frame
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
Title
Infant temperament
Description
The IBQ will be administered at 6-months postnatal to assess infant temperament
Time Frame
Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament
Other Pre-specified Outcome Measures:
Title
Change in Inflammation
Description
Inflammation will be assessed using blood samples at baseline, at the end of the third trimester of pregnancy and around 6 months postpartum. Change between baseline and the end of pregnancy, as well as between baseline and 6 months postpartum will be assessed.
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.
Title
Change in cortisol
Description
Systemic cortisol will be assessed using blood samples at baseline, at the end of the third trimester of pregnancy and around 6 months postpartum. Change between baseline and the end of pregnancy, as well as between baseline and 6 months postpartum will be assessed.
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.
Title
Personality dysfunctions
Description
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
Time Frame
Administered at one time-point, at the second trimester of pregnancy. The measure will assess current level of personality dysfunctions.
Title
Change in intimate partner violence
Description
Participants are invited to complete a self-report questionnaire of intimate partner violence. Change between baseline and 6 months postpartum will be assessed.
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1C3S2
Country
Canada
Facility Name
Centre intégré de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G6P 6N2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.projetstep.ca
Description
Related Info
URL
http://www.stepproject.ca
Description
Related Info
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Supporting the Transition to and Engagement in Parenthood
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