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临床试验/NCT07071766
NCT07071766招募中不适用

Adaptation and Implementation of an Evidence-Based Parenting Intervention for Postpartum Women Receiving Medications for Opioid Use Disorder

University of Arkansas1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Program Utilization

研究概览

简要总结

Drug overdose is a leading cause of death among postpartum women and opioid-related mortality is 4 times higher in the postpartum period when compared to the third trimester of pregnancy. Medications for opioid use disorder (MOUD; e.g., methadone or buprenorphine) are the recommended standard of care for perinatal women with OUD. Studies indicate that 50-60% of perinatal women with OUD initiate medications during pregnancy; however, over half will prematurely discontinue treatment within the first six months of childbirth due to stressors experienced in the postpartum period. Common stressors that contribute to MOUD treatment discontinuation in this population are return to opioid use, mental health symptoms including depression, parenting-related stressors such as challenges in infant care and bonding, Neonatal Abstinence Syndrome (NAS), child welfare involvement, and feelings of guilt, shame, and stigma. Thus, there is an urgent need to develop effective, recovery-oriented support interventions that promote the initiation and continuity of MOUD treatment in the postpartum period. The current study utilizes community-engaged research methods to identify and prioritize the early parenting-related needs of postpartum women receiving MOUD to inform the adaptation and implementation of an evidence-based parenting intervention for this population receiving outpatient treatment for opioid use disorder.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

入选标准

  • 18 years or older
  • Understand and speak English
  • Able to give informed consent
  • Receiving medications for opioid use disorder in the outpatient clinical setting
  • Between 28 weeks gestation and up to 12 months postpartum

排除标准

  • Unwilling to consent
  • Before 28 weeks gestation and beyond 12 months postpartum at enrollment

研究组 & 干预措施

Baby & Me

Experimental

Baby & Me is a manualized parenting education program originally developed for the use in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) offices in Arkansas. The program is designed to promote child well-being, reduce parental stress, and prevent child abuse and neglect among WIC recipients who are in their third trimester of pregnancy or have a newborn up to one-month of age. The program is delivered individually to new parents and caregivers via monthly 30-minute sessions over seven months and aims to ensure that new parents and caregivers receive evidence-based parenting education relevant to safe sleep practices, responding to infant cries, maternal mood and self-care, home safety, and developmental milestones. The original Baby & Me curricula was adapted to be delivered in outpatient substance use treatment settings to newly postpartum women receiving medications for opioid use disorder (MOUD) for this study.

干预措施: Proud of Baby and Me (Behavioral)

结局指标

主要结局

Program Utilization

时间窗: Up to 12 months after delivery

% of eligible women who choose to enroll in Baby \& Me

Program Acceptability

时间窗: Up to 12 months after delivery

Self-report ratings of the acceptability of Proud of Baby \& Me

Client Satisfaction

时间窗: Up to 12 months after delivery

Self-reported scores on the Client Satisfaction Questionnaire

次要结局

  • Depressive Symptoms(Up to 12 months after delivery)
  • Parenting Confidence(Up to 12 months after delivery)
  • Parental Stress(Up to 12 months after delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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