Nattpust for mødre etter fødsel med SUD
Pilotgjennomførbarhet for nattavlastning for mødre etter fødsel med rusforstyrrelser i behandlingsprogrammer for boliger
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Denne enarmspilotstudien vil evaluere implementeringen av avlastning for spedbarn over natten som tilbys omtrent 3 netter per uke i 6 uker (totalt 18 netter) til hver av 20 - 25 mødre med rusforstyrrelser i den tidlige postpartumperioden som bor i rusbruk i hjemmet. behandlingsprogrammer for lidelser. Avlastning over natten vil vare i åtte timer, med én time reservert hver morgen for å gi undervisning om spedbarnsspesifikke temperament og signaler. Programmet er et unikt offentlig/privat/akademisk partnerskap med Massachusetts Department of Children and Families (DCF), Boston Baby Nurse and Nanny (BBNN), to boligbehandlingsprogrammer og Massachusetts General Hospital.
I samarbeid med BBNN, vil nyfødtomsorgseksperter som er interessert i å gi avlastning til familier som er berørt av SUD, kobles sammen med postpartum-familier som bor i to boligbehandlingsprogrammer i Boston-området. New Day i Somerville, MA og Entre Familia i Mattapan, MA vil samarbeide med MGH for å rekruttere individer for å fullføre en screening og baselineinntak, motta nattavlastning og fullføre et oppfølgingsstudiebesøk ved fullføring av intervensjonen og etter 3 måneder etter intervensjon.
Denne studien vil bruke blandede metoder for å forstå gjennomførbarheten og akseptabiliteten av pilotintervensjonen, inkludert erfaringer fra dette pilotprogrammet gjennom perspektivene til programdeltakere, avlastningsgivere, overnattingspersonale og studiepersonell. Avlastere og ansatte i behandlingsprogrammet vil bli invitert til å delta i intervjuer etter at hver dyade har mottatt sine tildelte timer med avlastning for å reflektere over denne programdeltakerens spesifikke opplevelse.
BBNN, DCF og ledere for behandlingsprogrammet vil bli invitert til å delta i en fokusgruppe én gang etter fullføringen av studien for å forstå gjennomførbarheten, akseptabiliteten og implementeringen av dette programmet gjennom linsen til deres organisasjoner. De vil også bli invitert til å ta en kort spørreundersøkelse som tar sikte på å vurdere deres oppfatning av intervensjonens hensiktsmessighet og gjennomførbarhet.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Massachusetts
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Mattapan, Massachusetts, Forente stater, 02126
- Entre Familia Residential Treatment Program
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Somerville, Massachusetts, Forente stater, 02143
- New Day Residential Treatment Program
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- Omsorg for et spedbarn under 12 måneder.
- Å være den primære omsorgspersonen for spedbarnet deres.
- Å ha en DSM-5 diagnose av en rusforstyrrelse.
- Bor for tiden i et deltakende behandlingsprogram for boliger
- Engelsktalende eller spansktalende med begrensede engelskkunnskaper
Ekskluderingskriterier:
- Å ha en ubehandlet alvorlig psykisk lidelse.
- Har en ubehandlet rusmisbruksforstyrrelse eller eksisterende bekymring for at denne personen aktivt bruker stoffer.
- Har en historie med tidligere vold eller partnervold i hjemmet.
- Leverandørens bekymring angående ustabilitet eller mangel på informasjon om hjemmesikkerhet.
- Å ikke aktivt oppdra et spedbarn under 12 måneder
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Nattavlastning
18 avlastningsøkter over natten over seks uker med foreldreferdigheter gitt gjennom lærebare øyeblikk før og etter avlastningsstøtte
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(se beskrivelse ovenfor)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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
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
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Completion of consent and screening/baseline through end of intervention period, approximately 6 weeks
|
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Study Feasibility
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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
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)
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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)
|
|
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.
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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
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)
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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
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)
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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
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)
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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
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)
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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
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)
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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.
|
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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Davida M Schiff, MD, Massachusetts General Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025P001377
- K23DA048169 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
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