Supporting the Transition to and Engagement in Parenthood

NCT04829864 | Completed Phase 1

• 1 other identifier: STEP Phase 2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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 Outcomes (17)

• 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

  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

  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 perception of parental competence

  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 antenatal attachment

  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

  Administered at one time-point, at the end of the third trimester of pregnancy. The measure will assess current level of self-compassion.

Other Outcomes (4)

• Change in Inflammation

  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

  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

  Administered at one time-point, at the second trimester of pregnancy. The measure will assess current level of personality dysfunctions.

Study Arms (2)

STEP

EXPERIMENTAL

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

Usual prenatal cares

NO INTERVENTION

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

Interventions

STEP BEHAVIORAL

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.

STEP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe psychiatric disorders (schizophrenia, bipolar disorder)
• Severe emotional dysregulation
• Current self-harm
• Not sure to keep the child
• High level of hostility

Sponsors & Collaborators

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

Study Sites (2)

Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale

Québec, Quebec, G1C3S2, Canada

Location

Centre intégré de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec

Trois-Rivières, Quebec, G6P 6N2, Canada

Location

Related Links

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MeSH Terms

Conditions

Psychological Trauma; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: April 2, 2021
• Study Start: June 15, 2018
• Primary Completion: March 15, 2022
• Study Completion: May 15, 2023
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)