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

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).

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders
• Intervention / Treatment: Behavioral: Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT); Behavioral: Conventional Care

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MI and ACT; Participants will receive behavioral therapy including Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).	Behavioral: Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT); Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Entry	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)	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)	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)	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)	HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)	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)	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)	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)	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)	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)	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	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	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	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	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	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	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	Number of participant who test positive for drug use as assessed by urine drug screen	2 months
Drug use	Number of participant who test positive for drug use as assessed by urine drug screen	6 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Angela Stotts, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2017
• Primary Completion (Actual): January 3, 2020
• Study Completion (Actual): January 3, 2020

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: HSC-MS-15-0990; R34DA041465 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No