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Supporting the Transition to and Engagement in Parenthood (STEP)

13. Juni 2022 aktualisiert von: Nicolas Berthelot, Université du Québec à Trois-Rivières

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

110

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Übliche Schwangerschaftsvorsorge
Die Teilnehmer der Vergleichsgruppe erhalten die übliche Schwangerschaftsvorsorge (z. B. Geburtsvorbereitungskurse)
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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Wahrnehmung von Veränderungen in Funktionsbereichen während der Schwangerschaft
Zeitfenster: Wird zu einem bestimmten Zeitpunkt am Ende des dritten Schwangerschaftstrimesters verabreicht. Der Teilnehmer berichtet über wahrgenommene Veränderungen während der letzten 9 Monate.
Wir haben ein Instrument entwickelt, das die eigene Wahrnehmung von Veränderungen (negative Veränderungen zu positiven Veränderungen) in mehreren Funktionsbereichen bewertet, einschließlich der Qualität der Beziehung zum Partner; die Qualität der Beziehung zu bedeutenden anderen, Selbstwertgefühl; Emotionserkennung, -regulierung und -ausdruck; soziale Unterstützung und elterliches Vertrauen. Diese Bereiche werden separat bewertet.
Wird zu einem bestimmten Zeitpunkt am Ende des dritten Schwangerschaftstrimesters verabreicht. Der Teilnehmer berichtet über wahrgenommene Veränderungen während der letzten 9 Monate.
Grad der Zufriedenheit mit der Intervention
Zeitfenster: Die Zufriedenheit wird nach jeder Sitzung des Programms und nach dessen Ende bewertet. Die Zufriedenheit wird somit zwischen dem zweiten Schwangerschaftstrimester und der 36. Schwangerschaftswoche für einen Gesamtzeitraum von bis zu 7 Monaten beurteilt.
Die Teilnehmer werden gebeten, nach jeder Sitzung und am Ende des Programms einen Selbstberichtsfragebogen auszufüllen, in dem sie anhand einer Likert-Skala ihre Zufriedenheit bewerten. Am Ende des Programms wird außerdem ein halbstrukturiertes Interview geführt, das qualitative Informationen über ihre Wertschätzung des Programms liefert.
Die Zufriedenheit wird nach jeder Sitzung des Programms und nach dessen Ende bewertet. Die Zufriedenheit wird somit zwischen dem zweiten Schwangerschaftstrimester und der 36. Schwangerschaftswoche für einen Gesamtzeitraum von bis zu 7 Monaten beurteilt.
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
Zeitfenster: 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,
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
Zeitfenster: 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.
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
Zeitfenster: 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.
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.
Change in trauma-specific reflective functioning
Zeitfenster: 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.
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
Zeitfenster: 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.
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of reflective functions.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Veränderung der Wahrnehmung der elterlichen Kompetenz
Zeitfenster: Die Daten werden bei der Rekrutierung (2. Schwangerschaftstrimester) und in der 36. Schwangerschaftswoche erhoben. Der Begutachtungszeitraum umfasst somit einen Zeitraum von 7 Monaten.
Die Teilnehmer werden gebeten, einen Selbstberichtsfragebogen zum mütterlichen Selbstvertrauen auszufüllen (Fragebogen zum mütterlichen Selbstvertrauen). Die Veränderung zwischen dem Ausgangswert und dem Ende der Schwangerschaft wird beurteilt.
Die Daten werden bei der Rekrutierung (2. Schwangerschaftstrimester) und in der 36. Schwangerschaftswoche erhoben. Der Begutachtungszeitraum umfasst somit einen Zeitraum von 7 Monaten.
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
Zeitfenster: 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
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
Zeitfenster: 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
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of parental stress.
Maternal bonding
Zeitfenster: 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.
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of maternal bonding.
Maternal competence
Zeitfenster: 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.
Administered at one time-point, at the 6-months postpartum assessment. The measure will assess current level of perceived maternal competence..
Depression
Zeitfenster: 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.
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
Zeitfenster: 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
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
Zeitfenster: 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,
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
Zeitfenster: 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.
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
Infant socio-emotional development
Zeitfenster: 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.
Administered at one time-point, at 6-moths postpartum. The measure will assess current level of infant development.
Infant temperament
Zeitfenster: 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
Administered at one time-point, at 6-moths postpartum.The measure will assess current infant temperament

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Inflammation
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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
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
Zeitfenster: 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.
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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Université du Québec à Trois-Rivières

Mitarbeiter

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Juni 2018

Primärer Abschluss (Tatsächlich)

15. März 2022

Studienabschluss (Voraussichtlich)

15. Mai 2023

Studienanmeldedaten

Zuerst eingereicht

4. März 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. März 2021

Zuerst gepostet (Tatsächlich)

2. April 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Juni 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juni 2022

Zuletzt verifiziert

1. Juni 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STEP Phase 2

Plan für individuelle Teilnehmerdaten (IPD)

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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