SUD가 있는 산모를 위한 야간 휴식
주거 치료 프로그램에서 약물 사용 장애가 있는 산후 산모를 위한 야간 임시 간호의 시범적 타당성
연구 개요
상세 설명
이 단일 부문 파일럿 타당성 연구는 산후 초기에 약물 사용 장애가 있는 산모 20~25명 각각에게 6주 동안 주당 약 3일 밤(총 18일) 제공되는 야간 영아 휴식 간호의 구현을 평가할 것입니다. 장애 치료 프로그램. 야간 임시 간호는 8시간 동안 지속되며, 매일 아침 한 시간은 유아의 기질과 단서에 대한 교육을 제공합니다. 이 프로그램은 Massachusetts Department of Children and Families(DCF), Boston Baby Nurse and Nanny(BBNN), 2개의 주거 치료 프로그램 및 Massachusetts General Hospital과의 고유한 공공/민간/학술 파트너십입니다.
BBNN과 협력하여 SUD의 영향을 받는 가족에게 임시 간호를 제공하는 데 관심이 있는 신생아 관리 전문가는 보스턴 지역의 두 주거 치료 프로그램에 거주하는 산후 가족과 짝을 이룰 것입니다. 매사추세츠주 서머빌의 New Day와 매사추세츠주 마타판의 Entre Familia는 MGH와 협력하여 개인을 모집하여 스크리닝 및 기준선 섭취를 완료하고, 야간 임시 간호를 받고, 개입 완료 시 및 3개월에 후속 연구 방문을 완료할 예정입니다. 사후 개입.
이 연구는 프로그램 참여자, 휴식 간병인, 상주 치료 야간 직원 및 연구 직원의 관점을 통해 이 파일럿 프로그램의 경험을 포함하여 파일럿 개입의 타당성과 수용 가능성을 이해하기 위해 혼합 방법을 사용할 것입니다. 휴식 간병인과 거주 치료 프로그램 직원은 이 프로그램 참가자의 구체적인 경험을 반영하기 위해 각 부부가 할당된 휴식 간병 시간을 받은 후 인터뷰에 참여하도록 초대됩니다.
BBNN, DCF 및 주거 치료 프로그램 리더십 스태프는 조직의 렌즈를 통해 이 프로그램의 타당성, 수용성 및 구현을 이해하기 위해 연구 완료 시 초점 그룹에 한 번 참여하도록 초대됩니다. 그들은 또한 개입의 적절성과 타당성에 대한 인식을 평가하기 위한 간단한 설문조사에 참여하도록 초대될 것입니다.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Mattapan, Massachusetts, 미국, 02126
- Entre Familia Residential Treatment Program
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Somerville, Massachusetts, 미국, 02143
- New Day Residential Treatment Program
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 생후 12개월 미만의 유아 돌보기.
- 아기의 주요 보호자가 되는 것.
- 물질 사용 장애에 대한 DSM-5 진단을 받았습니다.
- 현재 참여 주거 치료 프로그램에 거주하고 있습니다.
- 제한된 영어 능력을 가진 영어 또는 스페인어 구사자
제외 기준:
- 치료받지 않은 심각한 정신 건강 질환이 있습니다.
- 치료받지 않은 물질 사용 장애가 있거나 이 사람이 물질을 적극적으로 사용하고 있다는 우려가 있습니다.
- 가정에서 이전 폭력 또는 친밀한 파트너 폭력의 역사가 있습니다.
- 가정 안전에 대한 정보 부족 또는 불안정성에 대한 공급자의 우려.
- 생후 12개월 미만의 유아를 적극적으로 양육하지 않음
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 야간 휴식 케어
임시 간호 지원 전후에 가르칠 수 있는 순간을 통해 부모 기술이 제공되는 6주 동안 18회의 야간 임시 간호 세션
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(위 설명 참조)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment
기간: Period from signing study consent form to completing screening and baseline, ranged from 1d to several weeks, on average less than a week
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Number of individuals who study consent AND completed screening and baseline, this being eligible to start intervention
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Period from signing study consent form to completing screening and baseline, ranged from 1d to several weeks, on average less than a week
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Participation in Intervention
기간: Completion of consent and screening/baseline through end of intervention period, approximately 6 weeks
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Reciept of any nights of respite care during the intervention period
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Completion of consent and screening/baseline through end of intervention period, approximately 6 weeks
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Study Feasibility
기간: At completion of the intervention, up to six weeks following the completion
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Count of total number individuals completing intervention and retained through study follow up
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At completion of the intervention, up to six weeks following the completion
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Study Acceptability
기간: At completion of the intervention, up to six weeks after last night of respite.
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Feedback in semi-structured interviews with participants
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At completion of the intervention, up to six weeks after last night of respite.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maternal Sleep Quantity
기간: Measurement began between 1 week and 1 day before starting respite and continued until at least one day after respite care ended, maximum of 8 weeks
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Measurement of total sleep using actigraphy device in a 24hr period
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Measurement began between 1 week and 1 day before starting respite and continued until at least one day after respite care ended, maximum of 8 weeks
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Ability to Fall Asleep
기간: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Insomnia Sleep Index (Measured on a scale of 0-28).
Insomnia symptoms were assessed using a brief insomnia symptom score capturing difficulty initiating sleep, maintaining sleep, and sleep satisfaction.
Higher scores indicate greater insomnia severity.
This measure was analyzed as a single continuous outcome reflecting insomnia symptom burden.
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Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Sleep Quality
기간: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Single Item Sleep Quality Scale; Overall perceived sleep quality was assessed using a single-item self-report measure asking participants to rate their global sleep quality over a recent time period. Higher scores reflect better perceived sleep quality. Single-item sleep quality measures have demonstrated sensitivity to change and strong correlations with multi-item sleep scales in postpartum populations. Participants rate their overall sleep quality using a single-item self-report measure. Scores range from 0 to 10, where 0 = terrible sleep quality and 10 = excellent sleep quality. Higher scores indicate better perceived sleep quality. |
Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Postpartum Sleep Quality
기간: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Postpartum-specific sleep quality was measured using the Postpartum Sleep Quality Scale is a caregiver-reported measure of postpartum sleep quality. The PSQS includes the following subscales: Infant-Related Sleep Disruption subscale: range 0-42 Physical Symptoms subscale: range 0-42 Total PSQS score: range 0-84, calculated by summing item responses across subscales. For all PSQS scores, higher values indicate worse postpartum sleep quality and greater sleep burden. |
Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Maternal Mental Health - Depression
기간: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Patient Health Questionnaire-8: Depressive symptoms were measured using the PHQ-8, an 8-item self-report scale assessing core symptoms of depression over the past two weeks.
Items are scored from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 24.
The PHQ-8 is a unidimensional measure and is widely used in postpartum and population-based studies.
A higher score indicates greater degree of depressive symptoms
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Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Maternal Mental Health - Anxiety
기간: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Anxiety symptoms were assessed using the GAD-7, a validated 7-item self-report measure of generalized anxiety symptoms over the past two weeks.
Items are scored on a 0-3 Likert scale, yielding a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity.
The GAD-7 is unidimensional and has demonstrated strong reliability and validity in perinatal populations.
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Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Recovery Capitol
기간: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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The BARC-10 is a 10-item self-report measure assessing personal, social, and community resources that support recovery from substance use disorder. Each item is scored from 1 to 6 and summed to create a total score. Total score range: 10-60 Higher scores indicate greater recovery capital and a better recovery-related outcome. The scale is analyzed as a single total score. |
Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Parental Stress
기간: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Parenting Stress Index-Short Form (PSI-SF). The PSI-SF is a 36-item caregiver-reported measure that yields three subscale scores and a Total Stress Score: Parental Distress (PD): range 12-60 Parent-Child Dysfunctional Interaction (P-CDI): range 12-60 Difficult Child (DC): range 12-60 Total Stress Score: range 36-180, calculated as the sum of the three subscales Higher scores indicate greater parenting stress and a worse outcome. |
Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Parental Bonding
기간: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Postpartum Bonding Questionnaire (PBQ); The PBQ is a 25-item caregiver-reported measure assessing disturbances in the parent-infant relationship. It includes the following subscales: Impaired Bonding: range 0-60 Rejection and Anger: range 0-36 Infant-Focused Anxiety: range 0-20 Risk of Abuse: range 0-12 Total PBQ score: range 0-100, calculated by summing all items Higher scores indicate greater bonding difficulties and a worse outcome. |
Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Parental Self-efficacy
기간: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Parenting self-efficacy was measured using the Perceived Maternal Parenting Self-Efficacy Scale, a multi-item self-report instrument assessing caregivers' confidence in their parenting skills and ability to manage parenting tasks. The Perceived Maternal Parenting Self-Efficacy Scale is a 20-item self-report measure assessing caregivers' confidence in their parenting abilities and performance of parenting tasks. Total score range: 20-80 (20 items scored 1-4 and summed) Higher scores indicate greater parenting self-efficacy and a better outcome. The scale is analyzed as a total score. |
Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Social Support
기간: Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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Perceived social support in the postpartum period was assessed using the Postpartum Social Support Screening tool, a caregiver-reported measure evaluating emotional, instrumental, and informational support.
The scale includes multiple items and is commonly analyzed as a total score reflecting overall perceived support.
There are 9 total questions that range from 1 (none of the time) to 5 (all of the time) and the total score is summed.
The scores can range from 9-45 and and high score indicate higher postpartum social support.
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Measured at baseline, at completion of intervention (up to six weeks post completion), and at three months following intervention (up to six weeks following three month post intervention)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Davida M Schiff, MD, Massachusetts General Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025P001377
- K23DA048169 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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