Improving Maternal Mental Health & SUD Screening and Treatment

Last updated: November 13, 2025
Sponsor: Medical University of South Carolina
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Addictions

Stimulant Use Disorder

Treatment

Listening to Women & Pregnant and Postpartum People

Clinical Study ID

NCT05764213
00123833
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

The purpose of the study is to compare a text message-based mental health and substance use screening and referral to a treatment program, called Listening to Women and Pregnant and Postpartum People (LTWP), to standard of care in-person mental health and substance use screening to look at rates of treatment attendance and retention in treatment. Participation would involve completing online questionnaires. You may be eligible to participate if you are age 18-45 years, are pregnant and entering prenatal care in one of MUSC's OB clinics, and attended a prenatal appointment at an MUSC clinic.

Eligibility Criteria

Inclusion

Aim 1:

This study is a cluster RCT step wedge design so we are randomizing on the clinic level, not the individual level. The clinics are made up of 4 "wedges" (3 clinics/wedge). Pregnant women receiving prenatal care in these clinics will receive SBIRT as part of usual care. Clusters of clinics will be randomized to an LTWP start date where they will transition from SBIRT to LTWP for the purposes of screening and referral to treatment.

EHR Data Collection (PPP):

Inclusion:

  1. Age 18-45

  2. pregnant and entering prenatal care in one of MUSC's OB clinics

  3. attended a prenatal appointment at an MUSC clinic

Exclusion:

a.) primary language is not English or Spanish

Aim 2:

Study Assessments at baseline and 2, 5, 8, and 11 months postpartum (PPP):

Inclusion:

  1. Age 18-45 years

  2. pregnant

  3. attended an initial prenatal appointment at an MUSC OB clinic

Exclusion:

  1. Unable to complete study assessments

  2. primary language is not English or Spanish

Study Design

Total Participants: 10473
Treatment Group(s): 1
Primary Treatment: Listening to Women & Pregnant and Postpartum People
Phase:
Study Start date:
April 03, 2023
Estimated Completion Date:
October 01, 2027

Study Description

Aim 1: To determine differences in rates of treatment attendance and retention for Perinatal Mood and Anxiety Disorders (PMADs) and Perinatal Substance Use Disorders (PSUDs) between participants assigned to LTWP, compared to SBIRT.

Aim 2: To determine differences in Patient-Reported Outcomes (PROs) including depressive symptoms, quality of life, substance use, and maternal functioning and well-being measured at baseline and 2, 5, 8, and 11 months postpartum.

Connect with a study center

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.