Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Arkansas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

Understand and speak English

Able to give informed consent

Receiving medications for opioid use disorder in the outpatient clinical setting

Disqualifiers

Unwilling to consent

Before 28 weeks gestation and beyond 12 months postpartum at enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Baby & MeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Program Utilization

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

Time frame
Up to 12 months after delivery
2

Program Acceptability

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

Time frame
Up to 12 months after delivery
3

Client Satisfaction

Self-reported scores on the Client Satisfaction Questionnaire

Time frame
Up to 12 months after delivery

Secondary outcomes

1

Depressive Symptoms

Self-report scores of the Edinburg Postnatal Depression Scale

Time frame
Up to 12 months after delivery
2

Parental Stress

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

Time frame
Up to 12 months after delivery
3

Parenting Confidence

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

Time frame
Up to 12 months after delivery

Other outcomes

1

Drug Use and Cravings

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

Time frame
Up to 12 months after delivery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arkansas

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator