Parents and Babies Pilot (PAB)
2026년 6월 1일 업데이트: Leiszle Rae Lapping-Carr, Northwestern University
Parents and Babies: Pilot Testing an Inclusive Preventive Postpartum Depression Intervention
The goal of this study will be piloting the Parents and Babies perinatal depression prevention intervention to examine its feasibility and acceptability and to obtain preliminary data on its efficacy.
This includes exploring/understanding users' experiences navigating the interventions (e.g., from an implementation perspective) and preliminary evaluations of clinical outcomes, including mental health and minority stress.
With data gathered from this pilot study, we will make final adaptations to the Parents and Babies manuals and plan to develop a randomized-control trial to evaluate efficacy of the intervention.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
16
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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연락하다:
- Leiszle Lapping-Carr
- 전화번호: 312- 503-3814
- 이메일: parentsandbabies@northwestern.edu
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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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- self-identify as LGBTQ+
- 18 years old or older
- live in the USA or territories
- speak and understand English
- Currently pregnant or within one year of childbirth
- Endorse current mild depressive symptoms or risk factors for postpartum depression
Exclusion Criteria:
- Are unable to consent/have impaired decision making capacity
- Have current active suicidal or homicidal ideation, active psychosis, or current mania
- Are currently experiencing a severe depressive episode
- Do not have audio and/or video capacity for attending group sessions remotely.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Virtual Group
Sessions will be delivered virtually.
Includes participants from across the US.
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Parents and Babies is a 10-session intervention adapted from Mothers and Babies, a nationally recognized intervention for depression during pregnancy and postpartum built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation.
Sessions are delivered virtually and led by a clinical psychologist.
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실험적: Hybrid Group
Sessions will be delivered virtually with three hybrid sessions with options for in-person attendance.
Includes only participants located in the Chicagoland area.
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Parents and Babies is a 10-session intervention adapted from Mothers and Babies, a nationally recognized intervention for depression during pregnancy and postpartum built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation.
Sessions are delivered virtually and led by a clinical psychologist, with an option for in-person participation at three sessions.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Implementation of Parents and Babies skills
기간: T2 (immediately post-intervention), T3 (3-months post-intervention)
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Parents and Babies Skill Utilization Survey - 8 item questionnaire to determine the extent to which one agrees that the PAB course taught skills related to the core modules, was useful, and was easy to understand; using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).
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T2 (immediately post-intervention), T3 (3-months post-intervention)
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Patient Health Questionnaire - 9 (PHQ-9)
기간: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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The Patient Health Questionnaire-9 is the 9 item depression module of the Patient Health Questionnaire.
It scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Higher scores indicate an increased severity of depression symptoms.
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T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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Perceived Stress Scale (PSS-10)
기간: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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The Perceived Stress Scale (PSS-10; Cohen, Kamarch, & Mermelstein,1983) is a 10 item measure of the degree to which situations in one's life are appraised as stressful with responses rated on a 5-point Likert scale (0 =never to 4 =very often).
Higher scores indicate greater perceived stress.
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T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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Generalized Anxiety Disorder Scale (GAD-7)
기간: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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The Generalized Anxiety Disorder Scale (Spitzer et.al, 2006) is a 7 item self-report measure used to assess anxiety.
Participants are queried regarding symptoms during the past two weeks and responses are tallied on a four-point Likert scale.
(0 = not at all to 3=nearly every day.)
Higher scores indicate an increased severity of anxiety symptoms.
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T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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Multidimensional Scale of Perceived Social Support (MSPSS)
기간: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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The Multidimensional Scale of Perceived Social Support (Zimet et al. 1988) is a 12-item measure of perceived adequacy of social support from three sources: family, friends, & significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree).
Higher scores in each subscale indicate greater perceived support from that source.
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T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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The Acceptability of Intervention Measure (AIM)
기간: T2 (immediately post-intervention)
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The Acceptability of Intervention Measure (Weiner et al., 2017) is a four-item measure of implementation outcomes to determine the extent to which one believes an intervention is appealing and satisfactory on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).
Higher scores indicate greater perceived acceptability of the intervention.
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T2 (immediately post-intervention)
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Intervention Appropriateness Measure (IAM)
기간: T2 (immediately post-intervention)
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Intervention Appropriateness Measure (Weiner et al., 2017) is a four-item measure evaluating the extent to which one believes an intervention is suitable, relevant, compatible, and applicable to one's needs on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).
Higher scores indicate greater perceived appropriateness of the intervention.
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T2 (immediately post-intervention)
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Feasibility of Intervention Measure (FIM)
기간: T2 (immediately post-intervention)
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Feasibility of Intervention Measure (Weiner et al., 2017) is a four-item survey measuring the perceived feasibility of an intervention on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).
Higher scores indicate greater perceived feasibility of the intervention.
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T2 (immediately post-intervention)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2027년 4월 1일
연구 완료 (추정된)
2027년 4월 1일
연구 등록 날짜
최초 제출
2026년 5월 19일
QC 기준을 충족하는 최초 제출
2026년 5월 19일
처음 게시됨 (실제)
2026년 5월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 1일
마지막으로 확인됨
2026년 6월 1일
추가 정보
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. .