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Substance Use in Pregnancy - Optimizing Retention in Treatment

Substance Use in Pregnancy - Optimizing Retention in Treatment by Maximizing Opportunities for Management

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07104123
Acronym
SUPPORT-MOM
Enrollment
36
Registered
2025-08-05
Start date
2026-02-02
Completion date
2026-08-31
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

BEHAVIORALPatients will undergo a program of contingency management

Patients will enter into a 12 week program of contingency management

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Social Drivers: EnrollmentEnrollment VisitPercentage of eligible patients enrolled in the study
Social Drivers: ScreeningThrough study completion, up to six months postpartumPercentage of visits for enrolled patients with social drivers of health screening
Social Drivers: Documentation of Z-codesThrough study completion, up to six months postpartumPercentage of social driver screenings with z-codes documented
Contingency Management: Intervention Fidelity (Number of Visits)Weekly from enrollment up to 12 weeksNumber of CM sessions with fidelity to intervention, defined as meeting all six criteria on weekly CM visit checklist
Contingency Management: Intervention Fidelity (Percentage of Visits)Weekly from enrollment up to 12 weeksPercentage of CM sessions with fidelity to intervention, defined as meeting all six criteria on weekly CM visit checklist
Contingency Management: Acceptability of Intervention Measure (AIM)After 3 CM sessions (up to 3 weeks), end of intervention (up to 12 weeks)Weiner et al, Implement Sci, 2017
Contingency Management: Intervention Appropriateness Measure (IAM)After 3 CM sessions (up to 3 weeks), end of intervention (up to 12 weeks)Weiner et al, Implement Sci, 2017
Contingency Management: Feasibility of Intervention Measure (FIM)After 3 CM sessions (up to 3 weeks), end of intervention (up to 12 weeks)Weiner et al, Implement Sci, 2017

Secondary

MeasureTime frameDescription
Social Drivers: Frequency of Z-CodesEnd of intervention (up to 12 weeks postpartum)Frequency of of z-codes documented for each patient
Social Drivers: Percentage of Patients with ReferralsEnd of intervention (up to 12 weeks postpartum)Percentage of patients with referrals to support services

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJeannie C Kelly, MD, MS

Washington University School of Medicine

PRINCIPAL_INVESTIGATORAna Baumann Walker, PhD, MA

Washington University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026