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Supporting the Transition to and Engagement in Parenthood (STEP)

13 giugno 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

110

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Solite cure prenatali
I partecipanti al gruppo di confronto riceveranno le consuete cure prenatali (es. classi prenatali)
Sperimentale: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percezione del cambiamento nei domini del funzionamento durante la gravidanza
Lasso di tempo: Somministrato in un determinato momento, alla fine del terzo trimestre di gravidanza. Il partecipante riferirà sui cambiamenti percepiti durante gli ultimi 9 mesi.
Abbiamo sviluppato uno strumento che valuta la propria percezione del cambiamento (da cambiamento negativo a cambiamento positivo) attraverso molteplici domini di funzionamento, inclusa la qualità della relazione con il partner; la qualità della relazione con gli altri significativi, l'autostima; riconoscimento, regolazione ed espressione delle emozioni; sostegno sociale e fiducia dei genitori. Questi domini saranno valutati separatamente.
Somministrato in un determinato momento, alla fine del terzo trimestre di gravidanza. Il partecipante riferirà sui cambiamenti percepiti durante gli ultimi 9 mesi.
Grado di soddisfazione riguardo all'intervento
Lasso di tempo: Soddisfazione valutata dopo ogni sessione del programma e dopo la sua conclusione. La soddisfazione viene quindi valutata tra il secondo trimestre di gravidanza e le 36 settimane di gravidanza, per un periodo di tempo totale fino a 7 mesi.
I partecipanti sono invitati a compilare un questionario di autovalutazione valutando il loro livello di soddisfazione dopo ogni sessione e alla fine del programma, utilizzando una scala Likert. Alla fine del programma viene anche somministrato un colloquio semi-strutturato che fornirà informazioni qualitative sul loro apprezzamento del programma.
Soddisfazione valutata dopo ogni sessione del programma e dopo la sua conclusione. La soddisfazione viene quindi valutata tra il secondo trimestre di gravidanza e le 36 settimane di gravidanza, per un periodo di tempo totale fino a 7 mesi.
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cambiamento nella percezione della competenza genitoriale
Lasso di tempo: I dati saranno raccolti al reclutamento (2° trimestre di gravidanza) ea 36 settimane di gravidanza. Il periodo di valutazione copre quindi un periodo di 7 mesi.
I partecipanti sono invitati a compilare un questionario di autovalutazione della fiducia materna (questionario di fiducia materna). Verrà valutata la variazione tra il basale e la fine della gravidanza.
I dati saranno raccolti al reclutamento (2° trimestre di gravidanza) ea 36 settimane di gravidanza. Il periodo di valutazione copre quindi un periodo di 7 mesi.
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Inflammation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Université du Québec à Trois-Rivières

Collaboratori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 giugno 2018

Completamento primario (Effettivo)

15 marzo 2022

Completamento dello studio (Anticipato)

15 maggio 2023

Date di iscrizione allo studio

Primo inviato

4 marzo 2021

Primo inviato che soddisfa i criteri di controllo qualità

31 marzo 2021

Primo Inserito (Effettivo)

2 aprile 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 giugno 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 giugno 2022

Ultimo verificato

1 giugno 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STEP Phase 2

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sponsor e collaboratori

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CROs by country

CROs in Trinidad & Tobago

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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