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NCT Number: NCT07071766

Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location status: Recruiting

Location contact

Mollee K Steely Smith, PhD

CONTACT

[email protected]

501-320-7271

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Program Utilization

    Time frame: Up to 12 months after delivery

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

  2. Program Acceptability

    Time frame: Up to 12 months after delivery

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

  3. Client Satisfaction

    Time frame: Up to 12 months after delivery

    Self-reported scores on the Client Satisfaction Questionnaire

Secondary outcomes

  1. Depressive Symptoms

    Time frame: Up to 12 months after delivery

    Self-report scores of the Edinburg Postnatal Depression Scale

  2. Parental Stress

    Time frame: Up to 12 months after delivery

    Self-reported scores on the Parenting Stress Index - Short Form

  3. Parenting Confidence

    Time frame: Up to 12 months after delivery

    Self-reported scores of perceived parenting confidence on the Karitane Parenting Confidence Scale

Other outcomes

  1. Drug Use and Cravings

    Time frame: Up to 12 months after delivery

    Self-reported drug use and cravings using the NIDA Modified ASSIST

Study contacts

Contact information is provided by the study sponsor or research team.

Mollee K Steely Smith, PhD

CONTACT

[email protected]

501-526-8174

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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