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Completed

NCT Number: NCT03165565

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

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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

Primary outcomes

  1. Treatment Entry

    Time frame: 8 weeks

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

  2. Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)

    Time frame: 2 months

    Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)

  3. Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)

    Time frame: 6 months

    Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)

  4. HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)

    Time frame: 2 months

    HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)

  5. HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)

    Time frame: 6 months

    HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)

Secondary outcomes

  1. Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: 2 months

    Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)

  2. Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: 6 months

    Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)

  3. Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)

    Time frame: 2 months

    Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)

  4. Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)

    Time frame: 6 months

    Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)

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

    Time frame: 2 months

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

    Time frame: 6 months

    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.

  7. Number of participants whose infant had routine follow-up pediatric appointments

    Time frame: 6 months

    Medical records will be used, with participant consent, to assess the number of participants whose infant had routine follow-up pediatric appointments.

  8. Number of participants whose infant had acute care visits

    Time frame: 6 months

    Medical records will be used, with participant consent, to assess the number of participants whose infant had acute care visits.

  9. Number of participants whose infant had emergency department visits

    Time frame: 6 months

    Medical records will be used, with participant consent, to assess the number of participants whose infant had emergency department visits.

  10. Number of participants whose infant was re-hospitalized

    Time frame: 6 months

    Medical records will be used, with participant consent, to assess the number of participants whose infant was re-hospitalized.

  11. Number of participants who lost custody of the infant

    Time frame: 6 months

    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.

  12. Number of participants for which any additional abuse or neglect complaints were filed after baseline

    Time frame: 6 months

    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.

  13. Drug use

    Time frame: 2 months

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

  14. Drug use

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Facilitating Treatment Entry and Family Planning in Substance-using NICU Mothers

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 24, 2017
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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