Parents and Babies Pilot (PAB)
3 de agosto de 2026 atualizado por: Leiszle Rae Lapping-Carr, Northwestern University
Parents and Babies: Pilot Testing an Inclusive Preventive Postpartum Depression Intervention
The goal of this study will be piloting the Parents and Babies perinatal depression prevention intervention to examine its feasibility and acceptability and to obtain preliminary data on its efficacy.
This includes exploring/understanding users' experiences navigating the interventions (e.g., from an implementation perspective) and preliminary evaluations of clinical outcomes, including mental health and minority stress.
With data gathered from this pilot study, we will make final adaptations to the Parents and Babies manuals and plan to develop a randomized-control trial to evaluate efficacy of the intervention.
Visão geral do estudo
Status
Recrutamento
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
16
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Recrutamento
- Northwestern University
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Contato:
- Leiszle Lapping-Carr
- Número de telefone: 312- 503-3814
- E-mail: parentsandbabies@northwestern.edu
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- self-identify as LGBTQ+
- 18 years old or older
- live in the USA or territories
- speak and understand English
- Currently pregnant or within one year of childbirth
- Endorse current mild depressive symptoms or risk factors for postpartum depression
Exclusion Criteria:
- Are unable to consent/have impaired decision making capacity
- Have current active suicidal or homicidal ideation, active psychosis, or current mania
- Are currently experiencing a severe depressive episode
- Do not have audio and/or video capacity for attending group sessions remotely.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Virtual Group
Sessions will be delivered virtually.
Includes participants from across the US.
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Parents and Babies is a 10-session intervention adapted from Mothers and Babies, a nationally recognized intervention for depression during pregnancy and postpartum built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation.
Sessions are delivered virtually and led by a clinical psychologist.
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Experimental: Hybrid Group
Sessions will be delivered virtually with three hybrid sessions with options for in-person attendance.
Includes only participants located in the Chicagoland area.
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Parents and Babies is a 10-session intervention adapted from Mothers and Babies, a nationally recognized intervention for depression during pregnancy and postpartum built on principles of cognitive-behavioral therapy (CBT), attachment theory, and psychoeducation.
Sessions are delivered virtually and led by a clinical psychologist, with an option for in-person participation at three sessions.
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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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Implementation of Parents and Babies skills
Prazo: T2 (immediately post-intervention), T3 (3-months post-intervention)
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Parents and Babies Skill Utilization Survey - 8 item questionnaire to determine the extent to which one agrees that the PAB course taught skills related to the core modules, was useful, and was easy to understand; using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).
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T2 (immediately post-intervention), T3 (3-months post-intervention)
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Patient Health Questionnaire - 9 (PHQ-9)
Prazo: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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The Patient Health Questionnaire-9 is the 9 item depression module of the Patient Health Questionnaire.
It scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Higher scores indicate an increased severity of depression symptoms.
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T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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Perceived Stress Scale (PSS-10)
Prazo: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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The Perceived Stress Scale (PSS-10; Cohen, Kamarch, & Mermelstein,1983) is a 10 item measure of the degree to which situations in one's life are appraised as stressful with responses rated on a 5-point Likert scale (0 =never to 4 =very often).
Higher scores indicate greater perceived stress.
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T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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Generalized Anxiety Disorder Scale (GAD-7)
Prazo: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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The Generalized Anxiety Disorder Scale (Spitzer et.al, 2006) is a 7 item self-report measure used to assess anxiety.
Participants are queried regarding symptoms during the past two weeks and responses are tallied on a four-point Likert scale.
(0 = not at all to 3=nearly every day.)
Higher scores indicate an increased severity of anxiety symptoms.
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T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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Multidimensional Scale of Perceived Social Support (MSPSS)
Prazo: T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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The Multidimensional Scale of Perceived Social Support (Zimet et al. 1988) is a 12-item measure of perceived adequacy of social support from three sources: family, friends, & significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree).
Higher scores in each subscale indicate greater perceived support from that source.
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T1 (prior to starting intervention), T2 (immediately post-intervention), T3 (3 months post-intervention)
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The Acceptability of Intervention Measure (AIM)
Prazo: T2 (immediately post-intervention)
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The Acceptability of Intervention Measure (Weiner et al., 2017) is a four-item measure of implementation outcomes to determine the extent to which one believes an intervention is appealing and satisfactory on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).
Higher scores indicate greater perceived acceptability of the intervention.
|
T2 (immediately post-intervention)
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Intervention Appropriateness Measure (IAM)
Prazo: T2 (immediately post-intervention)
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Intervention Appropriateness Measure (Weiner et al., 2017) is a four-item measure evaluating the extent to which one believes an intervention is suitable, relevant, compatible, and applicable to one's needs on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).
Higher scores indicate greater perceived appropriateness of the intervention.
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T2 (immediately post-intervention)
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Feasibility of Intervention Measure (FIM)
Prazo: T2 (immediately post-intervention)
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Feasibility of Intervention Measure (Weiner et al., 2017) is a four-item survey measuring the perceived feasibility of an intervention on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).
Higher scores indicate greater perceived feasibility of the intervention.
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T2 (immediately post-intervention)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
3 de agosto de 2026
Conclusão Primária (Estimado)
1 de abril de 2027
Conclusão do estudo (Estimado)
1 de abril de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
19 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de maio de 2026
Primeira postagem (Real)
26 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STU00225523
- 5K23MD018092-03 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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