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

NCT03165565 | Completed

• 2 other identifiers: HSC-MS-15-0990R34DA041465
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (14)

• 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)

  6 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)

  6 months

• Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)

  2 months

Study Arms (2)

MI and ACT

EXPERIMENTAL

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)

Conventional Care

ACTIVE COMPARATOR

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

Interventions

Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) BEHAVIORAL

Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).

MI and ACT

Conventional Care BEHAVIORAL

Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers.

Conventional Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Angela Stotts, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 24, 2017
• Study Start: July 5, 2017
• Primary Completion: January 3, 2020
• Study Completion: January 3, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

US (1)