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

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT)
Conventional Care
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MI and ACT

Conventional Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Treatment Entry
Number of participants having at least one treatment session at a licensed substance use facility or with a licensed counselor
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)
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)
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)
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)

Secondary Outcome Measures

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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
Drug use
Number of participant who test positive for drug use as assessed by urine drug screen
Drug use
Number of participant who test positive for drug use as assessed by urine drug screen

Full Information

First Posted
May 23, 2017
Last Updated
November 17, 2020
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03165565
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
January 3, 2020 (Actual)
Study Completion Date
January 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MI and ACT
Arm Type
Experimental
Arm Description
Participants will receive behavioral therapy including Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
Arm Title
Conventional Care
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT)
Intervention Description
Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
Intervention Type
Behavioral
Intervention Name(s)
Conventional Care
Intervention Description
Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers.
Primary Outcome Measure Information:
Title
Treatment Entry
Description
Number of participants having at least one treatment session at a licensed substance use facility or with a licensed counselor
Time Frame
8 weeks
Title
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Description
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Time Frame
2 months
Title
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Description
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
Time Frame
6 months
Title
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
Description
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
Time Frame
2 months
Title
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
Description
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Description
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame
2 months
Title
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Description
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame
6 months
Title
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Description
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Time Frame
2 months
Title
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Description
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
Time Frame
6 months
Title
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
Description
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.
Time Frame
2 months
Title
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
Description
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.
Time Frame
6 months
Title
Number of participants whose infant had routine follow-up pediatric appointments
Description
Medical records will be used, with participant consent, to assess the number of participants whose infant had routine follow-up pediatric appointments.
Time Frame
6 months
Title
Number of participants whose infant had acute care visits
Description
Medical records will be used, with participant consent, to assess the number of participants whose infant had acute care visits.
Time Frame
6 months
Title
Number of participants whose infant had emergency department visits
Description
Medical records will be used, with participant consent, to assess the number of participants whose infant had emergency department visits.
Time Frame
6 months
Title
Number of participants whose infant was re-hospitalized
Description
Medical records will be used, with participant consent, to assess the number of participants whose infant was re-hospitalized.
Time Frame
6 months
Title
Number of participants who lost custody of the infant
Description
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.
Time Frame
6 months
Title
Number of participants for which any additional abuse or neglect complaints were filed after baseline
Description
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.
Time Frame
6 months
Title
Drug use
Description
Number of participant who test positive for drug use as assessed by urine drug screen
Time Frame
2 months
Title
Drug use
Description
Number of participant who test positive for drug use as assessed by urine drug screen
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Stotts, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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