- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04829864
Supporting the Transition to and Engagement in Parenthood (STEP)
13. juni 2022 oppdatert av: 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
110
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Quebec
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Québec, Quebec, Canada, G1C3S2
- Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale
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Trois-Rivières, Quebec, Canada, G6P 6N2
- Centre intégré de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Vanlige prenatale omsorger
Deltakere i sammenligningsgruppen vil motta vanlige svangerskapsomsorg (f.eks.
prenatale klasser)
|
|
Eksperimentell: 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Oppfatning av endring i funksjonsdomener under graviditet
Tidsramme: Administrert på ett tidspunkt, på slutten av tredje trimester av svangerskapet. Deltakeren vil rapportere om opplevde endringer i løpet av de siste 9 månedene.
|
Vi utviklet et instrument som vurderer ens oppfatning av endring (negativ endring til positiv endring) på tvers av flere funksjonsdomener, inkludert kvaliteten på forholdet til partneren; kvaliteten på forholdet til betydelige andre, selvtillit; følelsesgjenkjenning, regulering og uttrykk; sosial støtte og foreldrenes tillit.
Disse domenene vil bli vurdert separat.
|
Administrert på ett tidspunkt, på slutten av tredje trimester av svangerskapet. Deltakeren vil rapportere om opplevde endringer i løpet av de siste 9 månedene.
|
Nivå av tilfredshet med intervensjonen
Tidsramme: Tilfredsheten vurderes etter hver økt av programmet og etter avslutningen. Tilfredsheten vurderes dermed mellom andre trimester av svangerskapet og 36 uker av svangerskapet, for en total tidsramme på opptil 7 måneder.
|
Deltakerne inviteres til å fylle ut et selvrapporteringsskjema som vurderer deres tilfredshet etter hver økt og på slutten av programmet, ved hjelp av en Likert-skala.
Et semistrukturert intervju blir også administrert på slutten av programmet som vil gi kvalitativ informasjon om deres verdsettelse av programmet.
|
Tilfredsheten vurderes etter hver økt av programmet og etter avslutningen. Tilfredsheten vurderes dermed mellom andre trimester av svangerskapet og 36 uker av svangerskapet, for en total tidsramme på opptil 7 måneder.
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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Change in trauma-specific reflective functioning
Tidsramme: 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
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Endring i oppfatning av foreldres kompetanse
Tidsramme: Data vil bli samlet inn ved rekruttering (2. trimester av svangerskapet) og ved 36-uker av svangerskapet. Vurderingstidsrammen dekker dermed en periode på 7 måneder.
|
Deltakerne inviteres til å fylle ut et selvrapporterende spørreskjema om mors tillit (Maternal confidence questionnaire).
Endring mellom baseline og slutten av svangerskapet vil bli vurdert.
|
Data vil bli samlet inn ved rekruttering (2. trimester av svangerskapet) og ved 36-uker av svangerskapet. Vurderingstidsrammen dekker dermed en periode på 7 måneder.
|
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
Tidsramme: 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
Tidsramme: 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.
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Change in antenatal attachment
Tidsramme: 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
Tidsramme: 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.
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Connection to care
Tidsramme: 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.
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Change in emotion regulation strategies
Tidsramme: 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
Tidsramme: 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.
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Parental stress
Tidsramme: 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
Tidsramme: 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.
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Maternal competence
Tidsramme: 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..
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Depression
Tidsramme: 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.
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Maternal behaviors
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Inflammation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. juni 2018
Primær fullføring (Faktiske)
15. mars 2022
Studiet fullført (Forventet)
15. mai 2023
Datoer for studieregistrering
Først innsendt
4. mars 2021
Først innsendt som oppfylte QC-kriteriene
31. mars 2021
Først lagt ut (Faktiske)
2. april 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. juni 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. juni 2022
Sist bekreftet
1. juni 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STEP Phase 2
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