Repouso noturno para mães pós-parto com SUD
Viabilidade piloto de cuidados noturnos para mães no pós-parto com transtorno por uso de substâncias em programas de tratamento residencial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Este estudo de viabilidade piloto de braço único avaliará a implementação de cuidados noturnos para bebês durante a noite, fornecidos aproximadamente 3 noites por semana durante 6 semanas (18 noites no total) para cada uma das 20 a 25 mães com transtornos por uso de substâncias no período pós-parto inicial residentes em uso residencial de substâncias. programas de tratamento de transtornos. Os cuidados noturnos duram oito horas, com uma hora reservada todas as manhãs para fornecer ensino sobre temperamento e dicas específicas do bebê. O programa é uma parceria pública/privada/acadêmica exclusiva com o Departamento de Crianças e Famílias de Massachusetts (DCF), Boston Baby Nurse and Nanny (BBNN), dois programas de tratamento residencial e o Massachusetts General Hospital.
Em parceria com a BBNN, especialistas em cuidados com recém-nascidos interessados em fornecer cuidados temporários para famílias afetadas pelo SUD serão emparelhados com famílias pós-parto que residem em dois programas de tratamento residencial na área de Boston. A New Day em Somerville, MA e a Entre Familia em Mattapan, MA farão parceria com a MGH para recrutar indivíduos para completar uma triagem e ingestão inicial, receber cuidados noturnos e completar uma visita de estudo de acompanhamento na conclusão da intervenção e em 3 meses pós intervenção.
Este estudo usará métodos mistos para entender a viabilidade e aceitabilidade da intervenção piloto, incluindo experiências deste programa piloto através das perspectivas dos participantes do programa, cuidadores temporários, equipe de tratamento residencial noturno e equipe de estudo. Cuidadores temporários e funcionários do programa de tratamento residencial serão convidados a participar de entrevistas depois que cada díade receber suas horas atribuídas de cuidados temporários para refletir sobre a experiência específica deste participante do programa.
BBNN, DCF e a equipe de liderança do programa de tratamento residencial serão convidados a participar de um grupo focal uma vez após a conclusão do estudo para entender a viabilidade, aceitabilidade e implementação deste programa através das lentes de suas organizações. Eles também serão convidados a responder a uma breve pesquisa destinada a avaliar sua percepção da adequação e viabilidade da intervenção.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Descrição
Critério de inclusão:
- Cuidar de uma criança com menos de 12 meses de idade.
- Ser o cuidador principal de seu bebê.
- Ter um diagnóstico DSM-5 de um transtorno por uso de substâncias.
- Atualmente residindo em um programa de tratamento residencial participante
- Falantes de inglês ou espanhol com proficiência limitada em inglês
Critério de exclusão:
- Ter uma doença mental grave não tratada.
- Ter um transtorno de uso de substâncias não tratado ou preocupações existentes de que essa pessoa está usando substâncias ativamente.
- Ter um histórico de violência anterior ou violência por parceiro íntimo em casa.
- Preocupação do provedor em relação à instabilidade ou falta de informação sobre a segurança da casa.
- Não cuidar ativamente de uma criança com menos de 12 meses de idade
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Cuidados noturnos
18 sessões noturnas de cuidado temporário durante seis semanas com habilidades parentais fornecidas por meio de momentos de ensino antes e depois do suporte de cuidados temporários
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(ver descrição acima)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Recruitment
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Maternal Sleep Quantity
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Transtornos Relacionados a Narcóticos
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Transtornos Relacionados a Substâncias
- Distúrbios induzidos quimicamente
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Distúrbios relacionados a opioides
- Distúrbios do Sono Vigília
Outros números de identificação do estudo
- 2025P001377
- K23DA048169 (Concessão/Contrato do NIH dos EUA)
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