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

Not Applicable

Completed

Brief 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.

Detailed Description: 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/).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Listening to Women	Listening to Women	This group will receive text-message based SBIRT with phone based assessment and referral to treatment. The SBIRT is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.

Primary Outcome Measures

Name	Time	Method
Screened Positive (Specific Aim 1)	Baseline	We will compare the proportion of those screening positive that are referred to treatment among those assigned to LTWP, compared to TAU.
Completion of SBIRT (Specific Aim 1)	Baseline	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.
Referred to Treatment (Specific Aim 1)	Baseline	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.
Treatment Attendance (Specific Aim 1)	Baseline	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)

Secondary Outcome Measures

Name	Time	Method
Screened Positive (Specific Aim 2)	Baseline	Among those that completed a screen, proportion of participants that screened positive.
Referred to Treatment (Specific Aim 2)	Baseline	Among those that completed a screen, proportion of participants that were referred to treatment.
Treatment Attendance (Specific Aim 2)	Baseline	Among those that completed a screen, proportion of participants that attended a mental health or substance use treatment appointment.