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

Study Overview
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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).

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

Conditions
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Substance Use Disorders

Intervention / Treatment
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* Behavioral: Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT)
* Behavioral: Conventional Care


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MI and ACT<br>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)<br>* Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).<br>|
| Active Comparator: Conventional Care<br>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<br>* Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Entry | Number of participants having at least one treatment session at a licensed substance use facility or with a licensed counselor | 8 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Drug use | Number of participant who test positive for drug use as assessed by urine drug screen | 2 months | 
| Drug use | Number of participant who test positive for drug use as assessed by urine drug screen | 6 months |