Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment

Not Applicable

Not yet recruiting

• Conditions: Substance Use Treatment; Perinatal Substance Use; Parenting

• Registration Number: NCT07071766
• Lead Sponsor: University of Arkansas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-08
• Study First Posted: 2025-07-17
• Last Update Submitted: 2025-08-14
• Last Update Posted: 2025-08-15
• Study Start: 2025-10-01
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Program Utilization	Up to 12 months after delivery	% of eligible women who choose to enroll in Baby \& Me
Program Acceptability	Up to 12 months after delivery	Self-report ratings of the acceptability of Proud of Baby \& Me
Client Satisfaction	Up to 12 months after delivery	Self-reported scores on the Client Satisfaction Questionnaire

Secondary Outcome Measures

Name	Time	Method
Depressive Symptoms	Up to 12 months after delivery	Self-report scores of the Edinburg Postnatal Depression Scale
Parenting Confidence	Up to 12 months after delivery	Self-reported scores of perceived parenting confidence on the Karitane Parenting Confidence Scale
Parental Stress	Up to 12 months after delivery	Self-reported scores on the Parenting Stress Index - Short Form

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States