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N/A Completed N=415 Randomized Screening

Pilot Randomized Controlled Trial (RCT): Remote SBIRT Vs. In-Person SBIRT

Source: ClinicalTrials.gov NCT04630249 ↗
Enrolled (actual)
415
Serious AEs
1.5%
Results posted
Oct 2024
Primary outcomePrimary: Completion of SBIRT (Specific Aim 1) — 221; 63 Participants

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.

Outcome Measures

OutcomeResultp-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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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