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Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07071766
Enrollment
10
Registered
2025-07-17
Start date
2026-09-01
Completion date
2027-06-30
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenting, Perinatal Substance Use, Substance Use Treatment

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.

Interventions

BEHAVIORALProud 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.

Sponsors

University of Arkansas
Lead SponsorOTHER
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Program UtilizationUp to 12 months after delivery% of eligible women who choose to enroll in Baby \& Me
Program AcceptabilityUp to 12 months after deliverySelf-report ratings of the acceptability of Proud of Baby \& Me
Client SatisfactionUp to 12 months after deliverySelf-reported scores on the Client Satisfaction Questionnaire

Secondary

MeasureTime frameDescription
Depressive SymptomsUp to 12 months after deliverySelf-report scores of the Edinburg Postnatal Depression Scale
Parental StressUp to 12 months after deliverySelf-reported scores on the Parenting Stress Index - Short Form
Parenting ConfidenceUp to 12 months after deliverySelf-reported scores of perceived parenting confidence on the Karitane Parenting Confidence Scale

Countries

United States

Contacts

CONTACTMollee K Steely Smith, PhD
mksteelysmith@uams.edu501-526-8174
PRINCIPAL_INVESTIGATORMollee K Steely Smith, PhD

University of Arkansas

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026