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.
Participants: 450 adult, pregnant or postpartum women 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/).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
415
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.
Medical University of South Carolina
Charleston, South Carolina, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
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)
Time frame: Baseline
Screened Positive (Specific Aim 2)
Among those that completed a screen, proportion of participants that screened positive.
Time frame: Baseline
Referred to Treatment (Specific Aim 2)
Among those that completed a screen, proportion of participants that were referred to treatment.
Time frame: Baseline
Treatment Attendance (Specific Aim 2)
Among those that completed a screen, proportion of participants that attended a mental health or substance use treatment appointment.
Time frame: Baseline
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