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Facilitating Treatment Entry and Family Planning in Substance-using Neonatal Intensive Care Unit (NICU) Mothers

17 november 2020 uppdaterad av: 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

64

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • The University of Texas Health Science Center at Houston

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: MI and ACT
Participants will receive behavioral therapy including Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
Beteende: Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT)
Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
Aktiv komparator: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment Entry
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 6 months
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 2 months
Number of participant who test positive for drug use as assessed by urine drug screen
2 months
Drug use
Tidsram: 6 months
Number of participant who test positive for drug use as assessed by urine drug screen
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The University of Texas Health Science Center, Houston

Samarbetspartners

National Institute on Drug Abuse (NIDA)

Utredare

  • Huvudutredare: Angela Stotts, PhD, The University of Texas Health Science Center, Houston

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 juli 2017

Primärt slutförande (Faktisk)

3 januari 2020

Avslutad studie (Faktisk)

3 januari 2020

Studieregistreringsdatum

Först inskickad

23 maj 2017

Först inskickad som uppfyllde QC-kriterierna

23 maj 2017

Första postat (Faktisk)

24 maj 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 november 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 november 2020

Senast verifierad

1 november 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HSC-MS-15-0990
  • R34DA041465 (U.S.S. NIH-anslag/kontrakt)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Substansmissbruk

Kliniska prövningar på Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT)

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