Substance Use in Pregnant People - Optimizing Retention in Treatment

NCT07104123 | Recruiting

• 1 other identifier: R61DA062321
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Social Drivers: Enrollment

  Percentage of eligible patients enrolled in the study

  Enrollment Visit

• Social Drivers: Screening

  Percentage of visits for enrolled patients with social drivers of health screening

  Through study completion, up to six months postpartum

• Social Drivers: Documentation of Z-codes

  Percentage of social driver screenings with z-codes documented

  Through study completion, up to six months postpartum

• Contingency Management: Intervention Fidelity (Number of Visits)

  Number of CM sessions with fidelity to intervention, defined as meeting all six criteria on weekly CM visit checklist

  Weekly from enrollment up to 12 weeks

• Contingency Management: Intervention Fidelity (Percentage of Visits)

  Percentage of CM sessions with fidelity to intervention, defined as meeting all six criteria on weekly CM visit checklist

  Weekly from enrollment up to 12 weeks

• Contingency Management: Acceptability of Intervention Measure (AIM)

  Weiner et al, Implement Sci, 2017

  After 3 CM sessions (up to 3 weeks), end of intervention (up to 12 weeks)

• Contingency Management: Intervention Appropriateness Measure (IAM)

  Weiner et al, Implement Sci, 2017

  After 3 CM sessions (up to 3 weeks), end of intervention (up to 12 weeks)

• Contingency Management: Feasibility of Intervention Measure (FIM)

  Weiner et al, Implement Sci, 2017

  After 3 CM sessions (up to 3 weeks), end of intervention (up to 12 weeks)

Secondary Outcomes (2)

• Social Drivers: Frequency of Z-Codes

  End of intervention (up to 12 weeks postpartum)

• Social Drivers: Percentage of Patients with Referrals

  End of intervention (up to 12 weeks postpartum)

Study Arms (2)

Social drivers of health screening

EXPERIMENTAL

Other: Social drivers of health screening

Contingency Management

EXPERIMENTAL

Behavioral: Patients will undergo a program of contingency management

Interventions

Social drivers of health screening OTHER

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

Social drivers of health screening

Patients will undergo a program of contingency management BEHAVIORAL

Patients will enter into a 12 week program of contingency management

Contingency Management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

NOT YET RECRUITING

Washington University

St Louis, Missouri, 63108, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jeannie C Kelly, MD, MS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Ana Baumann Walker, PhD, MA

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa M Mills, BS

CONTACT

314-273-2279; melissa.mills@wustl.edu

Jeannie C Kelly, MD, MS

CONTACT

jckelly@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Start Date: 9/1/2025 End Date: 8/31/2028
• Access Criteria: Authorized users will access the data through the NICHD Data and Specimen Hub (DASH) repository and the NIH HEAL Initiative Data Platform

Locations

US (2)