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Clinical Trials/NCT03165565
NCT03165565
Completed
Not Applicable

Facilitating Treatment Entry and Family Planning in Substance-using NICU Mothers

The University of Texas Health Science Center, Houston1 site in 1 country64 target enrollmentJuly 5, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use Disorders
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
64
Locations
1
Primary Endpoint
Treatment Entry
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
July 5, 2017
End Date
January 3, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Angela L Stotts

Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Treatment Entry

Time Frame: 8 weeks

Number of participants having at least one treatment session at a licensed substance use facility or with a licensed counselor

Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)

Time Frame: 6 months

Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)

HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)

Time Frame: 6 months

HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)

Secondary Outcomes

  • 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)(6 months)
  • Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)(6 months)
  • Number of participants whose infant had routine follow-up pediatric appointments(6 months)
  • Number of participants whose infant had acute care visits(6 months)
  • Number of participants whose infant had emergency department visits(6 months)
  • Number of participants whose infant was re-hospitalized(6 months)
  • 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(6 months)
  • Drug use(6 months)

Study Sites (1)

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