Facilitating Treatment Entry and Family Planning in Substance-using Neonatal Intensive Care Unit (NICU) Mothers
17 novembre 2020 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
64
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Texas
-
Houston, Texas, États-Unis, 77030
- The University of Texas Health Science Center at Houston
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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).
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Treatment Entry
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 6 months
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 2 months
|
Number of participant who test positive for drug use as assessed by urine drug screen
|
2 months
|
|
Drug use
Délai: 6 months
|
Number of participant who test positive for drug use as assessed by urine drug screen
|
6 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Angela Stotts, PhD, The University of Texas Health Science Center, Houston
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
5 juillet 2017
Achèvement primaire (Réel)
3 janvier 2020
Achèvement de l'étude (Réel)
3 janvier 2020
Dates d'inscription aux études
Première soumission
23 mai 2017
Première soumission répondant aux critères de contrôle qualité
23 mai 2017
Première publication (Réel)
24 mai 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 novembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 novembre 2020
Dernière vérification
1 novembre 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HSC-MS-15-0990
- R34DA041465 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .