N/A
N=415
Pilot Randomized Controlled Trial (RCT): Remote SBIRT Vs. In-Person SBIRT
Pregnancy · Substance Use · Depression · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT04630249 ↗Enrolled (actual)
415
Serious AEs
1.5%
Results posted
Oct 2024
Primary outcome: Primary: Completion of SBIRT (Specific Aim 1) — 221; 63 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Listening to Women and Pregnant and Postpartum People (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion of SBIRT (Specific Aim 1) |
221; 63 | — |
| PRIMARY Screened Positive (Specific Aim 1) |
121; 11 | — |
| PRIMARY Referred to Treatment (Specific Aim 1) |
31; 2 | — |
| PRIMARY Treatment Attendance (Specific Aim 1) |
20; 1 | — |
| SECONDARY Screened Positive (Specific Aim 2) |
121; 11 | — |
| SECONDARY Referred to Treatment (Specific Aim 2) |
31; 2 | — |
| SECONDARY Treatment Attendance (Specific Aim 2) |
20; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- age 18-41; 2) currently pregnant or postpartum; 3) if pregnant, receiving prenatal care; 4) English fluency; 5) owner of a cell phone with short message service (SMS) text-message based capability; 6) access to Wireless Fidelity (WIFI) and a device to allow audio and video teleconferencing; 7) able to provide informed consent.
Exclusion Criteria: None
Data sourced from ClinicalTrials.gov (NCT04630249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.