Substance Use in Pregnant People - Optimizing Retention in Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Social drivers of health screening

    Other intervention

    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 management

    Behavioral

    Patients will enter into a 12 week program of contingency management

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Social drivers of health screeningExperimental treatment 1 intervention
Group B: Contingency ManagementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Social Drivers: Enrollment

Percentage of eligible patients enrolled in the study

Time frame
Enrollment Visit
2

Social Drivers: Screening

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

Time frame
Through study completion, up to six months postpartum
3

Social Drivers: Documentation of Z-codes

Percentage of social driver screenings with z-codes documented

Time frame
Through study completion, up to six months postpartum
4

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

Time frame
Weekly from enrollment up to 12 weeks

Secondary outcomes

1

Social Drivers: Frequency of Z-Codes

Frequency of of z-codes documented for each patient

Time frame
End of intervention (up to 12 weeks postpartum)
2

Social Drivers: Percentage of Patients with Referrals

Percentage of patients with referrals to support services

Time frame
End of intervention (up to 12 weeks postpartum)

Other outcomes

Sponsors and contacts

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Washington University School of Medicine

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator