Pilot Randomized Controlled Trial (RCT): Remote SBIRT Vs. In-Person SBIRT
Pilot RCT of Remote Mental Health and Substance Use Screening, Brief Intervention and Referral to Treatment (SBIRT), Compared to In-Person SBIRT for Peripartum Women
Sponsor study identifier
interventional
415
1 country
1
Study Start
December 15, 2020
Actual (reported)Primary Completion
July 21, 2023
Actual (reported)Study Completion
July 21, 2023
Actual (reported)Specific Aim 1: Conduct a pilot, small-scale randomized controlled trial to examine feasibility and preliminary efficacy of LTW, compared to TAU. Outcomes related to feasibility include percentage of eligible patients recruited, study attrition, study retention, and mental health and substance use treatment appointment attendance. Outcomes related to preliminary efficacy will include participation in screening, referral and treatment at baseline, compared to TAU. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 21, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2, 2020
Actual (reported)November 16, 2020
Actual (reported)December 15, 2020
Actual (reported)July 21, 2023
Actual (reported)July 21, 2023
Actual (reported)October 18, 2024
Actual (reported)Completion of SBIRT (Specific Aim 1)
We will compare the proportion of participants that complete a screen for mental health and substance use among those assigned to LTWP, compared to TAU.
Baseline
Screened Positive (Specific Aim 1)
We will compare the proportion of those screening positive that are referred to treatment among those assigned to LTWP, compared to TAU.
Baseline
Referred to Treatment (Specific Aim 1)
We will compare the proportion of participants referred to treatment that had at least one mental health and/or substance use disorder treatment appointment among those assigned to LTWP, compared to TAU.
Baseline
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Limited data capture of primary outcomes in EHR, particularly for treatment attendance. Treatment may have occurred in other settings not captured by EHR. It is possible that participants in TAU were screened and referred but findings were not recorded in the EHR. The study took place within a single health system and findings may not be generalizable. It is unknown whether the screening completion rates within LTWP would differ in settings where staff do not enroll patients into LTWP.
415 participants (actual enrollment reported by the registry).
First Submitted
November 2, 2020
First Posted
November 16, 2020
Study Start
December 15, 2020
Actual (reported)Childbirth Education Pilot Study
Treatment Attendance (Specific Aim 1)
Treatment attendance (defined as attending at least 1 or more visits with a mental health and/or substance use disorder (SUD) treatment provider during pregnancy and the postpartum year)
Baseline
Screened Positive (Specific Aim 2)
Baseline
Referred to Treatment (Specific Aim 2)
Baseline
Treatment Attendance (Specific Aim 2)
Baseline
Primary Completion
July 21, 2023
Actual (reported)Study Completion
July 21, 2023
Actual (reported)Last Updated
October 18, 2024
Results First Posted
October 18, 2024
Record last verified: 2024-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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