Nachtruhe für postpartale Mütter mit SUD
Pilotdurchführbarkeit der nächtlichen Erholungspflege für Mütter nach der Geburt mit Substanzgebrauchsstörung in stationären Behandlungsprogrammen
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Diese einarmige Pilot-Durchführbarkeitsstudie wird die Implementierung einer nächtlichen Entlastungsbetreuung für Säuglinge bewerten, die etwa 3 Nächte pro Woche für 6 Wochen (insgesamt 18 Nächte) für jede von 20 - 25 Müttern mit Substanzkonsumstörungen in der frühen Zeit nach der Geburt bereitgestellt wird, die in einem häuslichen Drogenkonsum leben Programme zur Behandlung von Störungen. Die Nachtpflege dauert acht Stunden, wobei jeden Morgen eine Stunde reserviert ist, um Unterricht über kindspezifisches Temperament und Hinweise zu geben. Das Programm ist eine einzigartige öffentliche/private/akademische Partnerschaft mit dem Massachusetts Department of Children and Families (DCF), Boston Baby Nurse and Nanny (BBNN), zwei stationären Behandlungsprogrammen und dem Massachusetts General Hospital.
In Zusammenarbeit mit BBNN werden Experten für Neugeborenenpflege, die daran interessiert sind, Familien, die von SUD betroffen sind, Entlastungspflege anzubieten, mit postpartalen Familien zusammengebracht, die in zwei stationären Behandlungsprogrammen im Raum Boston leben. New Day in Somerville, MA und Entre Familia in Mattapan, MA werden mit MGH zusammenarbeiten, um Personen zu rekrutieren, die ein Screening und eine Basisaufnahme durchführen, eine nächtliche Erholungspflege erhalten und nach Abschluss der Intervention und nach 3 Monaten einen Folgestudienbesuch absolvieren nach Eingriff.
Diese Studie wird gemischte Methoden verwenden, um die Durchführbarkeit und Akzeptanz der Pilotintervention zu verstehen, einschließlich der Erfahrungen dieses Pilotprogramms aus der Perspektive der Programmteilnehmer, der Pflegekräfte, der Mitarbeiter der stationären Behandlung über Nacht und des Studienpersonals. Entlastungsbetreuer und Mitarbeiter des stationären Behandlungsprogramms werden eingeladen, an Interviews teilzunehmen, nachdem jede Dyade ihre zugeteilten Stunden der Entlastungspflege erhalten hat, um über die spezifischen Erfahrungen dieses Programmteilnehmers nachzudenken.
BBNN, DCF und leitende Mitarbeiter des stationären Behandlungsprogramms werden eingeladen, einmal nach Abschluss der Studie an einer Fokusgruppe teilzunehmen, um die Machbarkeit, Akzeptanz und Umsetzung dieses Programms durch die Linse ihrer Organisationen zu verstehen. Sie werden auch eingeladen, an einer kurzen Umfrage teilzunehmen, die darauf abzielt, ihre Wahrnehmung der Angemessenheit und Durchführbarkeit der Intervention zu bewerten.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Massachusetts
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Mattapan, Massachusetts, Vereinigte Staaten, 02126
- Entre Familia Residential Treatment Program
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Somerville, Massachusetts, Vereinigte Staaten, 02143
- New Day Residential Treatment Program
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Beschreibung
Einschlusskriterien:
- Betreuung eines Kleinkindes unter 12 Monaten.
- Die primäre Bezugsperson für ihr Kind sein.
- Eine DSM-5-Diagnose einer Substanzgebrauchsstörung haben.
- Derzeit wohnhaft in einem teilnehmenden stationären Behandlungsprogramm
- Englisch- oder spanischsprachige Personen mit begrenzten Englischkenntnissen
Ausschlusskriterien:
- Eine unbehandelte schwere psychische Erkrankung haben.
- Eine unbehandelte Substanzgebrauchsstörung oder bestehende Bedenken haben, dass diese Person aktiv Substanzen konsumiert.
- Vorgeschichte von früherer Gewalt oder Gewalt durch Intimpartner zu Hause.
- Besorgnis des Anbieters bezüglich Instabilität oder fehlender Informationen zur häuslichen Sicherheit.
- Keine aktive Erziehung eines Säuglings unter 12 Monaten
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Nachtpflege
18 nächtliche Entlastungspflegesitzungen über sechs Wochen mit elterlichen Fähigkeiten, die durch lehrbare Momente vor und nach der Entlastungspflegeunterstützung vermittelt werden
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(siehe Beschreibung oben)
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Recruitment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Maternal Sleep Quantity
Zeitfenster: 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
Zeitfenster: 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)
|
|
Sleep Quality
Zeitfenster: 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)
|
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Postpartum Sleep Quality
Zeitfenster: 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)
|
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Maternal Mental Health - Depression
Zeitfenster: 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
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
|
Parental Bonding
Zeitfenster: 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)
|
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Parental Self-efficacy
Zeitfenster: 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)
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Social Support
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Davida M Schiff, MD, Massachusetts General Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025P001377
- K23DA048169 (US NIH Stipendium/Vertrag)
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