Substance Use in Pregnant People - Optimizing Retention in Treatment

NCT ID: NCT07104123

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-08-31

Brief Summary

Substance use during pregnancy is a leading cause of maternal morbidity and mortality in the United States, with 55-80% of postpartum patients disengaging from substance use disorder (SUD) treatment within one year of delivery. Structural and social determinants of health, including housing instability, transportation barriers, and limited childcare access, further exacerbate disparities in treatment retention.

This pilot study, conducted in two specialized prenatal care clinics, evaluates the feasibility and acceptability of two integrated strategies to promote sustained engagement in recovery-oriented services during the perinatal and postpartum periods. Aim 1 implements a standardized social needs screening and referral protocol to connect patients with community-based supports. Aim 2 pilots a contingency management intervention to incentivize recovery-supportive behaviors.

Findings will inform the design of a larger multi-site randomized controlled trial to evaluate the impact of these interventions on treatment retention, overdose prevention, and maternal-infant health outcomes.

Detailed Description

Substance use during pregnancy remains a significant public health concern and is among the leading causes of maternal morbidity and mortality in the United States. Despite the availability of evidence-based interventions-including pharmacotherapy and behavioral counseling-treatment discontinuation in the postpartum period remains prevalent. Data from prior studies indicate that between 55% and 80% of postpartum patients disengage from substance use disorder (SUD) treatment within the first year following delivery. Disparities in treatment retention are further exacerbated by structural and social determinants of health, such as housing instability, transportation barriers, and limited access to childcare.

This pilot study is conducted in two specialized prenatal care clinics for individuals with SUD. The primary objective is to evaluate the feasibility and acceptability of two integrated, patient-centered strategies designed to promote sustained engagement in recovery-oriented services during the perinatal and postpartum periods.

Aim 1: Implementation of a Standardized Social Needs Screening and Referral Protocol This aim assesses the feasibility of deploying a structured, clinic-based protocol to systematically identify and address unmet social needs among pregnant patients with SUD. The protocol includes referral pathways to community-based services, including but not limited to perinatal home visiting programs, doulas, housing assistance, and transportation resources. Approximately 20 patients receiving care in the CARE clinic are enrolled to evaluate the clarity, usability, and clinical integration of the screening and referral process.

Aim 2: Pilot Testing of a Contingency Management Intervention This aim pilots a contingency management framework to incentivize engagement in recovery-supportive behaviors, such as attending scheduled appointments, adhering to treatment plans, and participating in supportive health activities. Contingency management demonstrates efficacy in other populations but has not been sufficiently adapted for use in perinatal SUD treatment settings. Approximately 20 patients are enrolled in this arm to assess the feasibility, fidelity, and preliminary acceptability of the intervention.

Both components of the study are designed to enhance long-term maternal recovery outcomes by delivering tailored, real-world supports that extend beyond delivery into the vulnerable postpartum period. Insights gained from this pilot study inform the development of a larger, multi-site randomized controlled trial to rigorously evaluate the impact of the interventions on treatment retention, overdose risk reduction, and maternal-infant health outcomes.

Conditions

Substance Use Disorder (SUD); Pregnancy; Postpartum; Contingency Management

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Social drivers of health screening

Group Type: EXPERIMENTAL

Social drivers of health screening

Intervention Type: OTHER

Patients will undergo a structured and protocoled screening for social drivers of health and be linked to support services

Contingency Management

Group Type: EXPERIMENTAL

Patients will undergo a program of contingency management

Intervention Type: BEHAVIORAL

Patients will enter into a 12 week program of contingency management

Interventions

Social drivers of health screening

Patients will undergo a structured and protocoled screening for social drivers of health and be linked to support services

Intervention Type: OTHER

Patients will undergo a program of contingency management

Patients will enter into a 12 week program of contingency management

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Confirmed viable intrauterine pregnancy at any gestational age, or within three years postpartum

SUD as defined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or clinician documentation

Exclusion Criteria

Decline follow-up care at study site

Require immediate hospitalization for unstable medical or psychiatric conditions making them clinically unsuitable to participate in a research study

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeannie C Kelly, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Ana Baumann Walker, PhD, MA

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Central Contacts

Jeannie C Kelly, MD, MS

Role: CONTACT

jckelly@wustl.edu

314-747-6788

Melissa M Mills, BS

Role: CONTACT

melissa.mills@wustl.edu

314 273 2279

Other Identifiers

R61DA062321-01

Identifier Type: NIH

Identifier Source: org_study_id

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