Répit de nuit pour les mères post-partum avec SUD
Faisabilité pilote des soins de relève de nuit pour les mères en post-partum souffrant de troubles liés à l'utilisation de substances dans les programmes de traitement en établissement
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Cette étude de faisabilité pilote à un seul bras évaluera la mise en œuvre de soins de relève pendant la nuit pour les nourrissons fournis environ 3 nuits par semaine pendant 6 semaines (18 nuits au total) à chacune des 20 à 25 mères souffrant de troubles liés à l'utilisation de substances au début de la période post-partum résidant dans un établissement résidentiel. programmes de traitement des troubles. Les soins de relève de nuit dureront huit heures, avec une heure réservée chaque matin pour fournir un enseignement sur le tempérament et les signaux spécifiques au nourrisson. Le programme est un partenariat public/privé/académique unique avec le Massachusetts Department of Children and Families (DCF), Boston Baby Nurse and Nanny (BBNN), deux programmes de traitement résidentiel et le Massachusetts General Hospital.
En partenariat avec BBNN, les experts en soins néonatals intéressés à fournir des soins de relève aux familles touchées par le SUD seront jumelés à des familles post-partum résidant dans deux programmes de traitement résidentiel dans la région de Boston. New Day à Somerville, MA et Entre Familia à Mattapan, MA s'associeront à MGH pour recruter des personnes pour effectuer un dépistage et une admission de base, recevoir des soins de relève de nuit et effectuer une visite d'étude de suivi à la fin de l'intervention et à 3 mois après intervention.
Cette étude utilisera des méthodes mixtes pour comprendre la faisabilité et l'acceptabilité de l'intervention pilote, y compris les expériences de ce programme pilote à travers les perspectives des participants au programme, des soignants de relève, du personnel de traitement résidentiel de nuit et du personnel de l'étude. Les soignants de relève et le personnel du programme de traitement en établissement seront invités à participer à des entrevues après que chaque dyade aura reçu ses heures de soins de relève pour réfléchir à l'expérience spécifique de ce participant au programme.
BBNN, DCF et le personnel de direction du programme de traitement résidentiel seront invités à participer à un groupe de discussion une fois à la fin de l'étude pour comprendre la faisabilité, l'acceptabilité et la mise en œuvre de ce programme à travers le prisme de leurs organisations. Ils seront également invités à répondre à un court sondage visant à évaluer leur perception de la pertinence et de la faisabilité de l'intervention.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Mattapan, Massachusetts, États-Unis, 02126
- Entre Familia Residential Treatment Program
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Somerville, Massachusetts, États-Unis, 02143
- New Day Residential Treatment Program
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La description
Critère d'intégration:
- Garde d'un enfant de moins de 12 mois.
- Être le principal gardien de leur bébé.
- Avoir un diagnostic DSM-5 d'un trouble lié à l'utilisation de substances.
- Résidant actuellement dans un programme de traitement résidentiel participant
- Anglophones ou hispanophones ayant une maîtrise limitée de l'anglais
Critère d'exclusion:
- Avoir une maladie mentale grave non traitée.
- Avoir un trouble lié à l'utilisation de substances non traité ou des inquiétudes existantes que cette personne consomme activement des substances.
- Avoir des antécédents de violence ou de violence conjugale à la maison.
- Préoccupation du fournisseur concernant l'instabilité ou le manque d'information sur la sécurité à domicile.
- Ne pas élever activement un enfant de moins de 12 mois
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Soins de nuit de relève
18 séances de soins de relève de nuit sur six semaines avec des compétences parentales fournies à travers des moments propices à l'apprentissage avant et après les soins de relève
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(voir descriptif ci-dessus)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Recruitment
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Maternal Sleep Quantity
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Davida M Schiff, MD, Massachusetts General Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025P001377
- K23DA048169 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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