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- Klinische proef NCT03165565
Facilitating Treatment Entry and Family Planning in Substance-using Neonatal Intensive Care Unit (NICU) Mothers
17 november 2020 bijgewerkt door: 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).
Studie Overzicht
Toestand
Voltooid
Studietype
Ingrijpend
Inschrijving (Werkelijk)
64
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Texas
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Houston, Texas, Verenigde Staten, 77030
- The University of Texas Health Science Center at Houston
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Treatment Entry
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Angela Stotts, PhD, The University of Texas Health Science Center, Houston
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
5 juli 2017
Primaire voltooiing (Werkelijk)
3 januari 2020
Studie voltooiing (Werkelijk)
3 januari 2020
Studieregistratiedata
Eerst ingediend
23 mei 2017
Eerst ingediend dat voldeed aan de QC-criteria
23 mei 2017
Eerst geplaatst (Werkelijk)
24 mei 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 november 2020
Laatste update ingediend die voldeed aan QC-criteria
17 november 2020
Laatst geverifieerd
1 november 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HSC-MS-15-0990
- R34DA041465 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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