- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03165565
Facilitating Treatment Entry and Family Planning in Substance-using Neonatal Intensive Care Unit (NICU) Mothers
17 de noviembre de 2020 actualizado 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
64
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- The University of Texas Health Science Center at Houston
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: MI and ACT
Participants will receive behavioral therapy including Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
|
Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
|
Comparador activo: 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.
|
Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Treatment Entry
Periodo de tiempo: 8 weeks
|
Number of participants having at least one treatment session at a licensed substance use facility or with a licensed counselor
|
8 weeks
|
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Periodo de tiempo: 2 months
|
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
|
2 months
|
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Periodo de tiempo: 6 months
|
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
|
6 months
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
Periodo de tiempo: 2 months
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
|
2 months
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
Periodo de tiempo: 6 months
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Periodo de tiempo: 2 months
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
|
2 months
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Periodo de tiempo: 6 months
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
|
6 months
|
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Periodo de tiempo: 2 months
|
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
|
2 months
|
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Periodo de tiempo: 6 months
|
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
|
6 months
|
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
Periodo de tiempo: 2 months
|
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.
|
2 months
|
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
Periodo de tiempo: 6 months
|
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.
|
6 months
|
Number of participants whose infant had routine follow-up pediatric appointments
Periodo de tiempo: 6 months
|
Medical records will be used, with participant consent, to assess the number of participants whose infant had routine follow-up pediatric appointments.
|
6 months
|
Number of participants whose infant had acute care visits
Periodo de tiempo: 6 months
|
Medical records will be used, with participant consent, to assess the number of participants whose infant had acute care visits.
|
6 months
|
Number of participants whose infant had emergency department visits
Periodo de tiempo: 6 months
|
Medical records will be used, with participant consent, to assess the number of participants whose infant had emergency department visits.
|
6 months
|
Number of participants whose infant was re-hospitalized
Periodo de tiempo: 6 months
|
Medical records will be used, with participant consent, to assess the number of participants whose infant was re-hospitalized.
|
6 months
|
Number of participants who lost custody of the infant
Periodo de tiempo: 6 months
|
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.
|
6 months
|
Number of participants for which any additional abuse or neglect complaints were filed after baseline
Periodo de tiempo: 6 months
|
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.
|
6 months
|
Drug use
Periodo de tiempo: 2 months
|
Number of participant who test positive for drug use as assessed by urine drug screen
|
2 months
|
Drug use
Periodo de tiempo: 6 months
|
Number of participant who test positive for drug use as assessed by urine drug screen
|
6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Angela Stotts, PhD, The University of Texas Health Science Center, Houston
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
5 de julio de 2017
Finalización primaria (Actual)
3 de enero de 2020
Finalización del estudio (Actual)
3 de enero de 2020
Fechas de registro del estudio
Enviado por primera vez
23 de mayo de 2017
Primero enviado que cumplió con los criterios de control de calidad
23 de mayo de 2017
Publicado por primera vez (Actual)
24 de mayo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
17 de noviembre de 2020
Última verificación
1 de noviembre de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HSC-MS-15-0990
- R34DA041465 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Trastornos por uso de sustancias
-
Nanfang Hospital of Southern Medical UniversityShenzhen People's Hospital; Second Affiliated Hospital of Guangzhou Medical UniversityAún no reclutandoLesiones Pancreáticas Sólidas | USE-FNB
-
Asan Medical CenterDesconocidoUSE-PAAF | CitodiagnósticoCorea, república de
-
Milton S. Hershey Medical CenterNational Cancer Institute (NCI)Activo, no reclutandoQuiste pancreático | USE-PAAFEstados Unidos
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityTerminadoCáncer de recto | USE-PAAF | Pathological Complete RemissionPorcelana
-
National Cheng-Kung University HospitalDesconocidoMétodo de succión húmeda basado en heparina en EUS Biopsia con aguja fina de masa pancreática sólidaNeoplasias pancreáticas | Ultrasonografía endoscópica | USE-PAAFTaiwán