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

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165565
• Other study ID #: HSC-MS-15-0990
• Secondary ID: R34DA041465
• Status: Completed
• Phase: N/A
• Start date: July 5, 2017
• Est. completion date: January 3, 2020

Study information

• Verified date: November 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 3, 2020
• Est. primary completion date: January 3, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Entry	Number of participants having at least one treatment session at a licensed substance use facility or with a licensed counselor	8 weeks
Primary	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)	2 months
Primary	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)	6 months
Primary	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)	2 months
Primary	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)	6 months
Secondary	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)	2 months
Secondary	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)	6 months
Secondary	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)	2 months
Secondary	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)	6 months
Secondary	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.	2 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Drug use	Number of participant who test positive for drug use as assessed by urine drug screen	2 months
Secondary	Drug use	Number of participant who test positive for drug use as assessed by urine drug screen	6 months