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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA041465 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI and ACT | Experimental | Participants will receive behavioral therapy including Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT). |
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| Conventional Care | Active Comparator | Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) | Behavioral | Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT). |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Stotts, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| 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. |
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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 |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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