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

NCT ID: NCT03165565

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-05

Study Completion Date

2020-01-03

Brief Summary

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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).

Detailed Description

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Conditions

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Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MI and ACT

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Conventional Care

Intervention Type BEHAVIORAL

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

Interventions

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

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Angela L Stotts

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela Stotts, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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R34DA041465

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-15-0990

Identifier Type: -

Identifier Source: org_study_id