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

The University of Texas System (UT)

Status: Completed

Conditions: Substance Use Disorders

Treatments: Behavioral: Conventional Care; Behavioral: Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03165565

R34DA041465 (U.S. NIH Grant/Contract)

HSC-MS-15-0990

Details and patient eligibility

About

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).

Enrollment: 64 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

64 participants in 2 patient groups

MI and ACT

Experimental group

Description:

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

Treatment:

Behavioral: Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT)

Conventional Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Conventional Care