Supporting the Transition to and Engagement in Parenthood (STEP)

Phase 2 of STEP (Supporting the Transition to and Engagement in Parenthood): A Prenatal Intervention for Women Who Experienced Childhood Trauma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mental Health Issue; Trauma, Psychological; Maternal Distress; Prenatal Stress
• Intervention / Treatment: Behavioral: STEP

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1C3S2
      • Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale
    • Trois-Rivières, Quebec, Canada, G6P 6N2
      • Centre intégré de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual prenatal cares; Participants of the comparison group will receive usual prenatal cares (ex. prenatal classes)
Experimental: STEP; 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.	Behavioral: STEP; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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.	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 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,	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.
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.	Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of reflective functions.
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.	Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
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.	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 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.	Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 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	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 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	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 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.	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.
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.	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	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	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.	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.
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.	Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of post-traumatic growth.
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.	Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of parental stress.
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.	Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of maternal bonding.
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.	Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of perceived maternal competence..
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.	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.
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	Administered at one time-point, around 12-months postpartum. The measure will assess current maternal behaviors..
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,	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.
Infant general development	The 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	The ASQ-SE 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	The 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
Change in Inflammation	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.	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 cortisol	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.	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.
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.
Change in intimate partner violence	Participants are invited to complete a self-report questionnaire of intimate partner violence. Change between baseline and 6 months postpartum 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.

Collaborators and Investigators

• Sponsor: Université du Québec à Trois-Rivières
• Collaborators: Public Health Agency of Canada (PHAC); Canada Research Chairs Endowment of the Federal Government of Canada; Social Sciences and Humanities Research Council of Canada

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): March 15, 2022
• Study Completion (Anticipated): May 15, 2023

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Well-being; Trauma; Attachment; Mentalization; Maternal bonding
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Wounds and Injuries; Psychological Trauma
• Other Study ID Numbers: STEP Phase 2

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