Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proud of Baby and Me.
- Who it may be relevant to
- Registry conditions: Substance Use Treatment, Perinatal Substance Use, Parenting. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adaptation and Implementation of an Evidence-Based Parenting Intervention for Postpartum Women Receiving Medications for Opioid Use Disorder
Overview
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
- Behavioral Proud 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.
Primary outcome measures
- Program Utilization [Time frame: Up to 12 months after delivery]
- Program Acceptability [Time frame: Up to 12 months after delivery]
- Client Satisfaction [Time frame: Up to 12 months after delivery]
Secondary outcome measures (3)
- Depressive Symptoms [Time frame: Up to 12 months after delivery]
- Parental Stress [Time frame: Up to 12 months after delivery]
- Parenting Confidence [Time frame: Up to 12 months after delivery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Arkansas for Medical Sciences — Little Rock
Identifiers
NCT: NCT07071766 · 287138