Improving Maternal Mental Health & SUD Screening and Treatment

April 2, 2026 updated by: Constance Guille, Medical University of South Carolina

Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

10470

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Screening Brief Intervention & Referral to Treatment (SBIRT)
This group will receive in-person screening and referral to treatment assessment.
Experimental: Listening to Women & Pregnant & Postpartum People (LTWP)
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, and other drugs including prescription medication), and domestic violence.
Behavioral: Listening to Women & Pregnant and Postpartum People
Participants are enrolled in 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Treatment Attendance
Time Frame: Through participants baseline prenatal care appointment and pregnancy and the postpartum year for participants, approximately 21 months
Treatment attendance is defined as attending at least 1 or more visits with a mental health or substance use disorder treatment provider.
Through participants baseline prenatal care appointment and pregnancy and the postpartum year for participants, approximately 21 months
Change in Retention in Treatment
Time Frame: Through participants baseline prenatal care appointment and pregnancy and the postpartum year for participants, approximately 21 months
Retention in treatment for PMADs: defined as 6 or more psychotherapy visits and/or 4 or more medication management visits; and PSUDs: are defined as continuous pharmacological and/or behavioral treatment > 2 months.
Through participants baseline prenatal care appointment and pregnancy and the postpartum year for participants, approximately 21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Maternal Functioning and Wellbeing
Time Frame: Change from baseline maternal functioning to follow-up maternal functioning during the postpartum year, approximately over 21 months.

We will compare the change in maternal functioning measured by the Barkin Index of Maternal Functioning among those assigned to LTWP compared to SBIRT.

Each item is rated on a 7-point likert scale ranging from 0 = "strongly disagree" to 6 = "strongly agree". The total score ranges from 0 to 120. Higher levels of functioning are associated with higher total scores with 120 representing optimal functioning. Lower levels of functioning are associated with lower scores.
Change from baseline maternal functioning to follow-up maternal functioning during the postpartum year, approximately over 21 months.
Change in depressive symptoms
Time Frame: Change from baseline depression screening symptoms to follow-up depression screening symptoms during the postpartum year, approximately over 21 months.

We will compare the mean change in the Edinburgh Postnatal Depression Scale (EPDS) among those assigned to LTWP compared to SBIRT.

A score of 10 or more on the EPDS suggests clinically elevated depressive symptoms requiring further evaluation.

A higher score on the EPDS is a worse outcome.
Change from baseline depression screening symptoms to follow-up depression screening symptoms during the postpartum year, approximately over 21 months.
Change in Substance Use
Time Frame: Change from baseline substance use to follow-up substance use during the postpartum year, approximately over 21 months.

We will compare the change in substance use frequency and amount as measured by the ASSIST among those assigned to LTWP compared to SBIRT.

A score of 0-3 (0-4 for cannabis) has an indicated response for brief education, a score of 4-26 (5-26 for cannabis) has an indicated response for brief intervention, a score of 27+ has an indicated response for brief intervention (offer options that include treatment).
Change from baseline substance use to follow-up substance use during the postpartum year, approximately over 21 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Constance Guille, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00123833

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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