Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment

NCT ID: NCT07071766

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-06-30

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.

Conditions

Substance Use Treatment; Perinatal Substance Use; Parenting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Baby & Me

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.

Group Type: EXPERIMENTAL

Proud of Baby and Me

Intervention Type: BEHAVIORAL

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.

Interventions

Proud of Baby and Me

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mollee K Steely Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Central Contacts

Mollee K Steely Smith, PhD

Role: CONTACT

mksteelysmith@uams.edu

501-526-8174

Facility Contacts

Mollee K Steely Smith, PhD

Role: primary

mksteelysmith@uams.edu

501-320-7271

Other Identifiers

287138

Identifier Type: -

Identifier Source: org_study_id