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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Proud of Baby and Me
BehavioralThe 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
Trial outcomes
Primary outcomes
Program Utilization
% of eligible women who choose to enroll in Baby \& Me
Program Acceptability
Self-report ratings of the acceptability of Proud of Baby \& Me
Client Satisfaction
Self-reported scores on the Client Satisfaction Questionnaire
Secondary outcomes
Depressive Symptoms
Self-report scores of the Edinburg Postnatal Depression Scale
Parental Stress
Self-reported scores on the Parenting Stress Index - Short Form
Parenting Confidence
Self-reported scores of perceived parenting confidence on the Karitane Parenting Confidence Scale
Other outcomes
Drug Use and Cravings
Self-reported drug use and cravings using the NIDA Modified ASSIST
Sponsors and contacts
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University of Arkansas
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator