Substance Use Disorder (SUD)SUPPORT-MOMNCT07104123
Substance Use in Pregnancy - Optimizing Retention in Treatment
A study testing Social drivers of health screening and Patients will undergo a program of contingency management in people with Substance Use Disorder (SUD) and Pregnancy, run by Washington University School of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Substance Use Disorder (SUD), Pregnancy, Postpartum
- What is being tested?
- Social drivers of health screening and Patients will undergo a program of contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Feb 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland
Baltimore, Maryland, 21201
Washington University
St Louis, Missouri, 63108
About this study
Official title: Substance Use in Pregnancy - Optimizing Retention in Treatment by Maximizing Opportunities for Management
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.
Read the 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.
- Being tested
- Social drivers of health screening, Patients will undergo a program of contingency management
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social drivers of health screeningOther
Patients will undergo a structured and protocoled screening for social drivers of health and be linked to support services
Patients will undergo a program of contingency managementBehavioural
Patients will enter into a 12 week program of contingency management
| Study group | Role | What they receive |
|---|---|---|
| Social drivers of health screening | Experimental | Not described Receives: Other: Social drivers of health screening |
| Contingency Management | Experimental | Not described Receives: Behavioral: Patients will undergo a program of contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Drivers: Enrollment
Percentage of eligible patients enrolled in the study
Measured: Enrollment Visit
Social Drivers: Screening
Percentage of visits for enrolled patients with social drivers of health screening
Measured: Through study completion, up to six months postpartum
Social Drivers: Documentation of Z-codes
Percentage of social driver screenings with z-codes documented
Measured: 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
Measured: 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
Measured: Weekly from enrollment up to 12 weeks
Contingency Management: Acceptability of Intervention Measure (AIM)
Weiner et al, Implement Sci, 2017
Measured: 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
Measured: 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
Measured: After 3 CM sessions (up to 3 weeks), end of intervention (up to 12 weeks)
Secondary outcomes (2)
Social Drivers: Frequency of Z-Codes
Frequency of of z-codes documented for each patient
Measured: End of intervention (up to 12 weeks postpartum)
Social Drivers: Percentage of Patients with Referrals
Percentage of patients with referrals to support services
Measured: End of intervention (up to 12 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start2 Feb 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jeannie C Kelly, MD, MS, Principal investigator, Washington University School of MedicineAna Baumann Walker, PhD, MA, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104123
- Sponsor's protocol ID
- R61DA062321
- Other IDs
- R61DA062321
- Acronym
- SUPPORT-MOM
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NICHD Data and Specimen Hub (DASH)
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use in Pregnancy - Optimizing Retention in Treatment by Maximizing Opportunities for Management
- ClinicalTrials.gov ID
- NCT07104123
- Acronym / sponsor ID
- SUPPORT-MOM / R61DA062321
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social drivers of health screening | Experimental | Other: Social drivers of health screening |
| Contingency Management | Experimental | Behavioral: Patients will undergo a program of contingency management |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social drivers of health screeningPatients will undergo a structured and protocoled screening for social drivers of health and be linked to support services | Other | Social drivers of health screening |
| Patients will undergo a program of contingency managementPatients will enter into a 12 week program of contingency management | Behavioural | Contingency Management |
Primary outcome
Social Drivers: Enrollment
Time frame: Enrollment Visit
Percentage of eligible patients enrolled in the study
Social Drivers: Screening
Time frame: Through study completion, up to six months postpartum
Percentage of visits for enrolled patients with social drivers of health screening
Social Drivers: Documentation of Z-codes
Time frame: Through study completion, up to six months postpartum
Percentage of social driver screenings with z-codes documented
Contingency Management: Intervention Fidelity (Number of Visits)
Time frame: Weekly from enrollment up to 12 weeks
Number 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)
Time frame: Weekly from enrollment up to 12 weeks
Percentage 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)
Time frame: 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)
Time frame: 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)
Time frame: After 3 CM sessions (up to 3 weeks), end of intervention (up to 12 weeks)
Weiner et al, Implement Sci, 2017
2 secondary outcomes
Social Drivers: Frequency of Z-Codes
Time frame: End of intervention (up to 12 weeks postpartum)
Social Drivers: Percentage of Patients with Referrals
Time frame: End of intervention (up to 12 weeks postpartum)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes. NICHD Data and Specimen Hub (DASH)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeannie C Kelly, MD, MS principal investigator
Washington University School of Medicine
Ana Baumann Walker, PhD, MA principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social drivers of health screening and Patients will undergo a program of contingency management in people with Substance Use Disorder (SUD) and Pregnancy, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Drivers: Enrollment (time frame: Enrollment Visit). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.