Clinical trial NCT03165565: Facilitating Treatment Entry and Family Planning in Substance-using Neonatal Intensive Care Unit (NICU) Mothers
Official title: Facilitating Treatment Entry and Family Planning in Substance-using NICU Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-05-24
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Treatment Entry
timeFrame: 8 weeks
measure: Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
timeFrame: 2 months
measure: Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
timeFrame: 6 months
measure: HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
timeFrame: 2 months
measure: HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
timeFrame: 6 months
Secondary outcomes:
measure: Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 2 months
measure: Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: 6 months
measure: Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
timeFrame: 2 months
measure: Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
timeFrame: 6 months
measure: Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
timeFrame: 2 months
measure: Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
timeFrame: 6 months
measure: Number of participants whose infant had routine follow-up pediatric appointments
timeFrame: 6 months
measure: Number of participants whose infant had acute care visits
timeFrame: 6 months
measure: Number of participants whose infant had emergency department visits
timeFrame: 6 months
measure: Number of participants whose infant was re-hospitalized
timeFrame: 6 months
measure: Number of participants who lost custody of the infant
timeFrame: 6 months
measure: Number of participants for which any additional abuse or neglect complaints were filed after baseline
timeFrame: 6 months
measure: Drug use
timeFrame: 2 months
measure: Drug use
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Angela Stotts, PhD
role: PRINCIPAL_INVESTIGATOR
References: