Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment

NCT07071766 | Recruiting

• 1 other identifier: 287138
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Perinatal Substance Use; Parenting; Substance Use Treatment

Outcome Measures

Primary Outcomes (3)

• Program Utilization

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

  Up to 12 months after delivery

• Program Acceptability

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

  Up to 12 months after delivery

• Client Satisfaction

  Self-reported scores on the Client Satisfaction Questionnaire

  Up to 12 months after delivery

Secondary Outcomes (3)

• Depressive Symptoms

  Up to 12 months after delivery

• Parental Stress

  Up to 12 months after delivery

• Parenting Confidence

  Up to 12 months after delivery

Other Outcomes (1)

• Drug Use and Cravings

  Up to 12 months after delivery

Study Arms (1)

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.

Behavioral: Proud of Baby and Me

Interventions

Proud of Baby and Me 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.

Baby & Me

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Study Officials

• Mollee K Steely Smith, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mollee K Steely Smith, PhD

CONTACT

501-526-8174; mksteelysmith@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)