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临床试验/NCT07104123
NCT07104123已完成不适用

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

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Social Drivers: Enrollment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Social drivers of health screening

Experimental

干预措施: Social drivers of health screening (Other)

Contingency Management

Experimental

干预措施: Patients will undergo a program of contingency management (Behavioral)

结局指标

主要结局

Social Drivers: Enrollment

时间窗: Enrollment Visit

Percentage of eligible patients enrolled in the study

Social Drivers: Screening

时间窗: 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

时间窗: Through study completion, up to six months postpartum

Percentage of social driver screenings with z-codes documented

Contingency Management: Intervention Fidelity (Number of Visits)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

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

Weiner et al, Implement Sci, 2017

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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