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Supporting the Transition to and Engagement in Parenthood (STEP)

2022년 6월 13일 업데이트: 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.

연구 개요

상태

모집하지 않고 적극적으로

개입 / 치료

연구 유형

중재적

등록 (실제)

110

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 일반적인 산전 관리
비교 그룹의 참가자는 일반적인 산전 관리(예: 산전 수업)
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
임신 중 기능 영역의 변화에 ​​대한 인식
기간: 임신 3분기 말에 한 번에 투여합니다. 참가자는 지난 9개월 동안 감지된 변화에 대해 보고합니다.
우리는 파트너와의 관계의 질을 포함하여 기능의 여러 영역에 걸쳐 변화에 대한 인식(긍정적인 변화에 대한 부정적인 변화)을 평가하는 도구를 개발했습니다. 중요한 타인과의 관계의 질, 자존감; 감정 인식, 조절 및 표현; 사회적 지지와 부모의 신뢰. 이러한 도메인은 별도로 평가됩니다.
임신 3분기 말에 한 번에 투여합니다. 참가자는 지난 9개월 동안 감지된 변화에 대해 보고합니다.
개입에 대한 만족도
기간: 프로그램의 각 세션과 종료 후 평가된 만족도. 따라서 만족도는 임신 2기부터 임신 36주까지 총 7개월 동안 평가됩니다.
참가자는 리커트 척도를 사용하여 각 세션 후와 프로그램 종료 시 만족도를 평가하는 자가 보고 설문지를 작성하도록 초대됩니다. 반 구조화 된 인터뷰는 또한 프로그램의 감사에 관한 질적 정보를 제공하는 프로그램의 끝에 관리됩니다.
프로그램의 각 세션과 종료 후 평가된 만족도. 따라서 만족도는 임신 2기부터 임신 36주까지 총 7개월 동안 평가됩니다.
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
부모역량에 대한 인식의 변화
기간: 데이터는 모집(임신 2기) 및 임신 36주에 수집됩니다. 따라서 평가 기간은 7개월입니다.
참가자들은 모성 신뢰도에 대한 자가 보고 설문지(모성 신뢰도 설문지)를 작성하도록 초대됩니다. 기준선과 임신 말기 사이의 변화를 평가합니다.
데이터는 모집(임신 2기) 및 임신 36주에 수집됩니다. 따라서 평가 기간은 7개월입니다.
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Change in Inflammation
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 6월 15일

기본 완료 (실제)

2022년 3월 15일

연구 완료 (예상)

2023년 5월 15일

연구 등록 날짜

최초 제출

2021년 3월 4일

QC 기준을 충족하는 최초 제출

2021년 3월 31일

처음 게시됨 (실제)

2021년 4월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 6월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 6월 13일

마지막으로 확인됨

2022년 6월 1일

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

정신 건강 문제에 대한 임상 시험

STEP에 대한 임상 시험

3
구독하다