ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03165565
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Angela Stotts, The University of Texas Health Science Center, Houston

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 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).

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) Behavioral: Conventional Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Facilitating Treatment Entry and Family Planning in Substance-using NICU Mothers
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: MI and ACT
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)
Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).

Active Comparator: 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.
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.




Primary Outcome Measures :
  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 ]
  3. Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP) [ Time Frame: 6 months ]
  4. HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID) [ Time Frame: 2 months ]
  5. HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 2 months ]
  2. Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 6 months ]
  3. Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA) [ Time Frame: 2 months ]
  4. Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA) [ Time Frame: 6 months ]
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165565


Contacts
Contact: Angela Stotts, PhD (713) 500-7590 Angela.L.Stotts@uth.tmc.edu

Locations
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Angela Stotts, PhD    713-500-7590    Angela.L.Stotts@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Angela Stotts, PhD The University of Texas Health Science Center, Houston

Responsible Party: Angela Stotts, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03165565     History of Changes
Other Study ID Numbers: HSC-MS-15-0990
R34DA041465 ( U.S. NIH Grant/Contract )
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders