Relevo nocturno para madres posparto con SUD
Factibilidad piloto de cuidado de relevo nocturno para madres posparto con trastorno por uso de sustancias en programas de tratamiento residencial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Este estudio piloto de factibilidad de un solo brazo evaluará la implementación del cuidado de relevo infantil durante la noche proporcionado aproximadamente 3 noches por semana durante 6 semanas (18 noches en total) a cada una de 20 a 25 madres con trastornos por uso de sustancias en el período posparto temprano que residen en residencias por uso de sustancias. programas de tratamiento de trastornos. El cuidado de relevo durante la noche tendrá una duración de ocho horas, con una hora reservada cada mañana para brindar enseñanza sobre el temperamento y las señales específicas del bebé. El programa es una asociación pública/privada/académica única con el Departamento de Niños y Familias de Massachusetts (DCF), Boston Baby Nurse and Nanny (BBNN), dos programas de tratamiento residencial y el Hospital General de Massachusetts.
Al asociarse con BBNN, los expertos en atención de recién nacidos interesados en brindar atención de relevo a las familias afectadas por SUD se unirán con familias posparto que residen en dos programas de tratamiento residencial en el área de Boston. New Day en Somerville, MA y Entre Familia en Mattapan, MA se asociarán con MGH para reclutar personas para completar una evaluación y una admisión inicial, recibir cuidado de relevo nocturno y completar una visita de estudio de seguimiento al finalizar la intervención y a los 3 meses. post intervención.
Este estudio utilizará métodos mixtos para comprender la viabilidad y aceptabilidad de la intervención piloto, incluidas las experiencias de este programa piloto a través de las perspectivas de los participantes del programa, los cuidadores de relevo, el personal de tratamiento residencial durante la noche y el personal del estudio. Se invitará a los cuidadores de relevo y al personal del programa de tratamiento residencial a participar en entrevistas después de que cada díada reciba las horas asignadas de cuidado de relevo para reflexionar sobre la experiencia específica de este participante del programa.
BBNN, DCF y el personal de liderazgo del programa de tratamiento residencial serán invitados a participar en un grupo de enfoque una vez que finalice el estudio para comprender la viabilidad, la aceptabilidad y la implementación de este programa a través de la lente de sus organizaciones. También se les invitará a realizar una breve encuesta destinada a evaluar su percepción de la idoneidad y viabilidad de la intervención.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Mattapan, Massachusetts, Estados Unidos, 02126
- Entre Familia Residential Treatment Program
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Somerville, Massachusetts, Estados Unidos, 02143
- New Day Residential Treatment Program
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
- Cuidado de un bebé menor de 12 meses de edad.
- Ser el cuidador principal de su bebé.
- Tener un diagnóstico DSM-5 de un trastorno por uso de sustancias.
- Actualmente reside en un programa de tratamiento residencial participante
- Hablantes de inglés o español con dominio limitado del inglés
Criterio de exclusión:
- Tener una enfermedad mental grave no tratada.
- Tener un trastorno por uso de sustancias no tratado o preocupaciones existentes de que esta persona está usando sustancias activamente.
- Tener antecedentes de violencia previa o violencia de pareja íntima en el hogar.
- Preocupación del proveedor con respecto a la inestabilidad o la falta de información sobre la seguridad en el hogar.
- No criar activamente a un bebé menor de 12 meses de edad
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Cuidado de relevo nocturno
18 sesiones nocturnas de cuidado de relevo durante seis semanas con habilidades de los padres proporcionadas a través de momentos de enseñanza antes y después de los apoyos de cuidado de relevo
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(ver descripción arriba)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recruitment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maternal Sleep Quantity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Davida M Schiff, MD, Massachusetts General Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Trastornos relacionados con narcóticos
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Trastornos relacionados con sustancias
- Trastornos inducidos químicamente
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Trastornos relacionados con opioides
- Trastornos del sueño y la vigilia
Otros números de identificación del estudio
- 2025P001377
- K23DA048169 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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