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Natpusterum for postpartum mødre med SUD

18. august 2026 opdateret af: Davida M. Schiff, MD, Massachusetts General Hospital

Pilotgennemførlighed af natteaflastning for mødre efter fødslen med stofbrugsforstyrrelser i beboelsesbehandlingsprogrammer

Denne enarmede pilotgennemførlighedsundersøgelse vil evaluere implementeringen af ​​spædbørnspasning og forældrefærdigheder til mødre med stofmisbrug i den tidlige postpartum-periode, der bor i behandlingsprogrammer for stofmisbrug i boliger.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Denne enkeltarms pilotgennemførlighedsundersøgelse vil evaluere implementeringen af ​​aflastningspasning til spædbørn natten over, der ydes ca. 3 nætter om ugen i 6 uger (i alt 18 nætter) til hver af 20-25 mødre med stofmisbrug i den tidlige postpartum-periode, der bor i stofmisbrug programmer til behandling af lidelser. Aflastning natten over vil vare i otte timer, med en time reserveret hver morgen til at give undervisning om spædbarnsspecifikke temperament og signaler. Programmet er et unikt offentligt/privat/akademisk partnerskab med Massachusetts Department of Children and Families (DCF), Boston Baby Nurse and Nanny (BBNN), to boligbehandlingsprogrammer og Massachusetts General Hospital.

I samarbejde med BBNN vil eksperter i nyfødtpleje, der er interesseret i at give aflastning til familier, der er ramt af SUD, blive parret med familier efter fødslen, der bor i to boligbehandlingsprogrammer i Boston-området. New Day i Somerville, MA og Entre Familia i Mattapan, MA vil samarbejde med MGH for at rekruttere personer til at gennemføre en screening og baseline-indtagelse, modtage natteaflastning og gennemføre et opfølgende studiebesøg ved afslutningen af ​​interventionen og efter 3 måneder efter intervention.

Denne undersøgelse vil bruge blandede metoder til at forstå gennemførligheden og acceptabiliteten af ​​pilotinterventionen, herunder erfaringer fra dette pilotprogram gennem perspektiverne fra programdeltagere, aflastningspersonale, personale, der overnatter på overnatningssteder og undersøgelsespersonale. Aflastningspersonale og personale i behandlingsprogrammet vil blive inviteret til at deltage i interviews, efter at hver dyade har modtaget deres tildelte timers aflastning for at reflektere over denne programdeltagers specifikke oplevelse.

BBNN, DCF og ledelsespersonale i behandlingsprogrammet vil blive inviteret til at deltage i en fokusgruppe én gang ved afslutningen af ​​undersøgelsen for at forstå gennemførligheden, acceptablen og implementeringen af ​​dette program gennem deres organisationers linse. De vil også blive inviteret til at deltage i en kort undersøgelse med det formål at vurdere deres opfattelse af interventionens hensigtsmæssighed og gennemførlighed.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

41

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Massachusetts
      • Mattapan, Massachusetts, Forenede Stater, 02126
        • Entre Familia Residential Treatment Program
      • Somerville, Massachusetts, Forenede Stater, 02143
        • New Day Residential Treatment Program

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Pasning af et spædbarn under 12 måneder.
  • At være den primære vicevært for deres spædbarn.
  • At have en DSM-5 diagnose af en stofmisbrugsforstyrrelse.
  • Bor i øjeblikket i et deltagende behandlingsprogram
  • Engelsktalende eller spansktalende med begrænsede engelskkundskaber

Ekskluderingskriterier:

  • At have en ubehandlet alvorlig psykisk sygdom.
  • Har en ubehandlet stofmisbrugsforstyrrelse eller eksisterende bekymringer om, at denne person aktivt bruger stoffer.
  • At have en historie med tidligere vold eller vold i nære relationer i hjemmet.
  • Leverandørens bekymring vedrørende ustabilitet eller mangel på information om sikkerhed i hjemmet.
  • Ikke aktivt forældre til et spædbarn under 12 måneder

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Nataflastning
18 aflastningssessioner natten over i løbet af seks uger med forældrefærdigheder leveret gennem lærebare øjeblikke før og efter aflastningshjælp
(se beskrivelsen ovenfor)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment
Tidsramme: Period from signing study consent form to completing screening and baseline, ranged from 1d to several weeks, on average less than a week
Number of individuals who study consent AND completed screening and baseline, this being eligible to start intervention
Period from signing study consent form to completing screening and baseline, ranged from 1d to several weeks, on average less than a week
Participation in Intervention
Tidsramme: Completion of consent and screening/baseline through end of intervention period, approximately 6 weeks
Reciept of any nights of respite care during the intervention period
Completion of consent and screening/baseline through end of intervention period, approximately 6 weeks
Study Feasibility
Tidsramme: At completion of the intervention, up to six weeks following the completion
Count of total number individuals completing intervention and retained through study follow up
At completion of the intervention, up to six weeks following the completion
Study Acceptability
Tidsramme: At completion of the intervention, up to six weeks after last night of respite.
Feedback in semi-structured interviews with participants
At completion of the intervention, up to six weeks after last night of respite.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maternal Sleep Quantity
Tidsramme: 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
Measurement of total sleep using actigraphy device in a 24hr period
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
Ability to Fall Asleep
Tidsramme: 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)
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.
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)
Sleep Quality
Tidsramme: 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)

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)
Postpartum Sleep Quality
Tidsramme: 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)

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)
Maternal Mental Health - Depression
Tidsramme: 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)
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
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)
Maternal Mental Health - Anxiety
Tidsramme: 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)
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.
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)
Recovery Capitol
Tidsramme: 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)

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)
Parental Stress
Tidsramme: 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)

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)
Parental Bonding
Tidsramme: 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)

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)
Parental Self-efficacy
Tidsramme: 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)

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)
Social Support
Tidsramme: 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)
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.
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Davida M Schiff, MD, Massachusetts General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. december 2022

Primær færdiggørelse (Faktiske)

30. april 2025

Studieafslutning (Faktiske)

30. april 2025

Datoer for studieregistrering

Først indsendt

15. februar 2023

Først indsendt, der opfyldte QC-kriterier

25. februar 2023

Først opslået (Faktiske)

27. februar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2025P001377
  • K23DA048169 (U.S. NIH-bevilling/kontrakt)

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