Facilitating Treatment Entry and Family Planning in Substance-using Neonatal Intensive Care Unit (NICU) Mothers
17 de novembro de 2020 atualizado por: Angela L Stotts, The University of Texas Health Science Center, Houston
Facilitating Treatment Entry and Family Planning in Substance-using NICU Mothers
The purpose of this pilot study is to assess whether the hospital-based, adaptive behavioral intervention strategy promotes treatment entry and reduces risk of additional substance-exposed pregnancies (SEPs), as well as HIV and Hepatitis C Virus (HCV) risks among substance-using NICU mothers.
Additionally, to assess whether the intervention increases use of professional obstetrical/gynecological resources for contraception to reduce substance-exposed pregnancies (SEPs).
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
64
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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Texas
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Houston, Texas, Estados Unidos, 77030
- The University of Texas Health Science Center at Houston
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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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- have an infant in the NICU at Children's Memorial Hermann Hospital (CMHH)
- have a positive urine drug screen at delivery or have an infant with a positive urine or meconium drug screen or self-reported drug use to a healthcare provider or had a documented positive drug screen during pregnancy
- have access to a telephone.
Exclusion Criteria:
- currently attending substance abuse treatment
- severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
- inability to read, write, speak English or Spanish
- inability or unwillingness to provide signed consent for participation; (5) inability or unwillingness to meet study requirements.
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: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: MI and ACT
Participants will receive behavioral therapy including Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
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Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
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Comparador Ativo: Conventional Care
Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers.
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Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers.
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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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Treatment Entry
Prazo: 8 weeks
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Number of participants having at least one treatment session at a licensed substance use facility or with a licensed counselor
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8 weeks
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Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Prazo: 2 months
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Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
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2 months
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Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Prazo: 6 months
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Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
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6 months
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HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
Prazo: 2 months
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HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
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2 months
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HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
Prazo: 6 months
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HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Prazo: 2 months
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Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
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2 months
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Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Prazo: 6 months
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Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
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6 months
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Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Prazo: 2 months
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Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
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2 months
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Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Prazo: 6 months
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Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
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6 months
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Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
Prazo: 2 months
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This self-report measure of psychological flexibility will assess a participant's willingness to have undesirable thoughts and feelings related to drug use while still pursuing self-identified goals.
This version of the AAQ was specifically developed for substance-abusing populations.
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2 months
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Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
Prazo: 6 months
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This self-report measure of psychological flexibility will assess a participant's willingness to have undesirable thoughts and feelings related to drug use while still pursuing self-identified goals.
This version of the AAQ was specifically developed for substance-abusing populations.
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6 months
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Number of participants whose infant had routine follow-up pediatric appointments
Prazo: 6 months
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Medical records will be used, with participant consent, to assess the number of participants whose infant had routine follow-up pediatric appointments.
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6 months
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Number of participants whose infant had acute care visits
Prazo: 6 months
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Medical records will be used, with participant consent, to assess the number of participants whose infant had acute care visits.
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6 months
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Number of participants whose infant had emergency department visits
Prazo: 6 months
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Medical records will be used, with participant consent, to assess the number of participants whose infant had emergency department visits.
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6 months
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Number of participants whose infant was re-hospitalized
Prazo: 6 months
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Medical records will be used, with participant consent, to assess the number of participants whose infant was re-hospitalized.
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6 months
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Number of participants who lost custody of the infant
Prazo: 6 months
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Medical records will be used, with participant consent, and additionally the research team will collaborate with the NICU social worker and the assigned child protective services (CPS) caseworker, with participant consent, to obtain information about the number of participants who lost custody of the infant.
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6 months
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Number of participants for which any additional abuse or neglect complaints were filed after baseline
Prazo: 6 months
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Medical records will be used, with participant consent, and additionally the research team will collaborate with the NICU social worker and the assigned child protective services (CPS) caseworker, with participant consent, to obtain information about the number of participants for which any additional abuse or neglect complaints were filed after baseline.
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6 months
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Drug use
Prazo: 2 months
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Number of participant who test positive for drug use as assessed by urine drug screen
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2 months
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Drug use
Prazo: 6 months
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Number of participant who test positive for drug use as assessed by urine drug screen
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6 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Colaboradores
Investigadores
- Investigador principal: Angela Stotts, PhD, The University of Texas Health Science Center, Houston
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)
5 de julho de 2017
Conclusão Primária (Real)
3 de janeiro de 2020
Conclusão do estudo (Real)
3 de janeiro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
23 de maio de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de maio de 2017
Primeira postagem (Real)
24 de maio de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de novembro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de novembro de 2020
Última verificação
1 de novembro de 2020
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HSC-MS-15-0990
- R34DA041465 (Concessão/Contrato do NIH dos EUA)
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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