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Supporting the Transition to and Engagement in Parenthood

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04829864
Acronym
STEP
Enrollment
110
Registered
2021-04-02
Start date
2018-06-15
Completion date
2023-05-15
Last updated
2024-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Distress, Mental Health Issue, Prenatal Stress, Trauma, Psychological

Keywords

Mentalization, Maternal bonding, Trauma, Well-being, Attachment, Pregnancy

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.

Interventions

BEHAVIORALSTEP

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.

Sponsors

Public Health Agency of Canada (PHAC)
CollaboratorOTHER_GOV
Social Sciences and Humanities Research Council of Canada
CollaboratorOTHER
Canada Research Chairs Endowment of the Federal Government of Canada
CollaboratorOTHER_GOV
Université du Québec à Trois-Rivières
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Level of satisfaction concerning the interventionSatisfaction 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.
Change in trauma-specific reflective functioningData 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 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.
Parental reflective functioningAdministered 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 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.
Prenatal reflective functioningAdministered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of reflective functions.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.
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 postpartumData 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,
Perception of change in domains of functioning during pregnancyAdministered 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.

Secondary

MeasureTime frameDescription
Connection to careFrom 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
Change in emotion regulation strategiesData 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 (CERQ). Change between baseline and the end of pregnancy, as well as between baseline and 6 months postpartum will be assessed.
Post-traumatic growthAdministered 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 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 stressAdministered 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 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 competenceAdministered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of perceived 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.
DepressionData will be collected at 36-weeks of pregnancy and at 6-months postpartum. The assessment time frame thus covers a period of 7 months.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 behaviorsAdministered at one time-point, around 12-months postpartum. The measure will assess current 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 postpartumData 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,
Infant general developmentAdministered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.The ASQ-3 will be administered at 6-months postnatal to assess infant development.
Infant socio-emotional developmentAdministered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.The ASQ-SE will be administered at 6-months postnatal to assess infant socio-emotional development.
Infant temperamentAdministered at one time-point, at 6-moths postpartum.The measure will assess current infant temperamentThe IBQ will be administered at 6-months postnatal to assess infant temperament
Maternal bondingAdministered 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 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 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 postpartumData 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 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 postpartumData 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 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 competenceData 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.
Change in antenatal attachmentData 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 antenatal attachment (Maternal antenatal attachment scale). Change between baseline and the end of pregnancy will be assessed.
Self-compassionAdministered 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 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.

Other

MeasureTime frameDescription
Change in InflammationData 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.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.
Change in intimate partner violenceData 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 of intimate partner violence. Change between baseline and 6 months postpartum will be assessed.
Personality dysfunctionsAdministered 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
Change in cortisolData 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.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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026