Pilot Randomized Controlled Trial (RCT): Remote SBIRT Vs. In-Person SBIRT
NCT ID: NCT04630249
Last Updated: 2024-10-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
415 participants
INTERVENTIONAL
2020-12-15
2023-07-21
Brief Summary
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Specific Aim 2: Conduct a randomized controlled trial to examine the effectiveness of LTW, compared to TAU. Outcomes related to effectiveness include screening, screening positive, referred to and attendance to treatment at baseline, compared to TAU.
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Detailed Description
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Intervention: Listening to Women is a mobile phone-based program designed to enhance delivery of Screening, Brief Intervention, and Referral to Treatment (SBIRT), an evidence-based approach for mental health and substance use screening and treatment for perinatal women. This program was created as a result of key informant interviews with obstetric providers and pregnant and postpartum women with opioid use disorders. The program utilizes mobile phone text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, home-based telemedicine mental health and substance use disorder treatment services.
Design: Specific aim 1: A two arm pilot RCT (N=35) with 2:1 allocation will examine feasibility and preliminary efficacy of LTW, compared to TAU. Specific aim 2: A RCT (N=415) with 1:1 allocation will examine effectiveness of LTW, compared to TAU.
This study is part of the HEAL Initiative (https://heal.nih.gov/).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Listening to Women and Pregnant and Postpartum People
Participants are enrolled in text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, home-based telemedicine mental health and substance use disorder treatment services. The text screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
Listening to Women and Pregnant and Postpartum People
Participants are enrolled in text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, referral to telemedicine mental health and substance use disorder treatment services.
Usual Care
This group will receive in-person screening and referral to treatment by a nurse or physician per usual prenatal care. The in person screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.
No interventions assigned to this group
Interventions
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Listening to Women and Pregnant and Postpartum People
Participants are enrolled in text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, referral to telemedicine mental health and substance use disorder treatment services.
Eligibility Criteria
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Inclusion Criteria
18 Years
41 Years
FEMALE
No
Sponsors
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Medical University of South Carolina
OTHER
Responsible Party
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Constance Guille
Professor
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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00103742
Identifier Type: -
Identifier Source: org_study_id
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