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Completed

NCT Number: NCT04829864

Supporting the Transition to and Engagement in Parenthood

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.

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Key information

Conditions

Trauma, Psychological Maternal Distress Mental Disorders Mental Health Issue Prenatal Stress Psychological Trauma Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale, Québec, Quebec, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

    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,

  2. Perception of change in domains of functioning during pregnancy

    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.

    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.

  3. Level of satisfaction concerning the intervention

    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.

    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.

  4. Prenatal reflective functioning

    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.

    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.

  5. Parental reflective functioning

    Time frame: Administered 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.

  6. Change in trauma-specific reflective functioning

    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.

    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.

  7. Change in trauma-specific reflective functioning

    Time frame: Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.

    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 outcomes

  1. 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

    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.

    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

  2. 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

    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.

    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

  3. Change in perception of parental competence

    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.

    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.

  4. Change in antenatal attachment

    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.

    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.

  5. Self-compassion

    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.

    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.

  6. Connection to care

    Time frame: From 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

  7. Change in emotion regulation strategies

    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.

    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.

  8. Post-traumatic growth

    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.

    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.

  9. Parental stress

    Time frame: Administered 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.

  10. Maternal bonding

    Time frame: Administered 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.

  11. Maternal competence

    Time frame: Administered 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.

  12. Depression

    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.

    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.

  13. Maternal behaviors

    Time frame: Administered 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

  14. 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

    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.

    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,

  15. Infant general development

    Time frame: Administered 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.

  16. Infant socio-emotional development

    Time frame: Administered 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.

  17. Infant temperament

    Time frame: Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament

    The IBQ will be administered at 6-months postnatal to assess infant temperament

Other outcomes

  1. Change in Inflammation

    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.

    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.

  2. Change in cortisol

    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.

    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.

  3. Personality dysfunctions

    Time frame: Administered 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

  4. Change in intimate partner violence

    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.

    Participants are invited to complete a self-report questionnaire of intimate partner violence. Change between baseline and 6 months postpartum will be assessed.

Sponsors and collaborators

Lead sponsor

Université du Québec à Trois-Rivières

Other

Collaborators

  • Canada Research Chairs Endowment of the Federal Government of Canada
  • Public Health Agency of Canada (PHAC)
  • Social Sciences and Humanities Research Council of Canada

Registry information

Official study title

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

Acronym: STEP

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Apr 2, 2021
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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