Group well child care for mothers with opioid use disorder and their infants
Well Child Care Intervention for Infants of Mothers in Treatment for Opioid Use Disorder
This study is testing a group approach to well child care for mothers in treatment for opioid use disorder and their babies to see if it helps improve their health and healthcare outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05488379 on ClinicalTrials.gov |
What this trial studies
This project aims to implement and evaluate a group model of well child care specifically designed for mothers undergoing treatment for opioid use disorder and their infants. A total of 108 mother-infant dyads will be randomized into either group well child care or individual well child care, with follow-ups conducted over an 18-month period. The study will collect both qualitative and quantitative data at multiple time points to assess the effectiveness of the group care model in improving health and healthcare-related outcomes for opioid-exposed infants. The trial will take place at a single site, with participants receiving care within the Nemours/Thomas Jefferson University system.
Who should consider this trial
Good fit: Ideal candidates are pregnant women at least 28 weeks along or less than 2 weeks postpartum who are receiving treatment for opioid use disorder and plan to parent their infant.
Not a fit: Patients who do not speak English or plan to move outside the Philadelphia area within the next two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the health and well-being of infants exposed to opioids by providing tailored group care for their mothers.
How similar studies have performed: While similar group care models have shown promise in other contexts, this specific approach for mothers with opioid use disorder is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * at least 28 weeks pregnant or less than 2 weeks postpartum * receiving treatment for opioid use disorder * ability to read and speak English * plans to parent infant after delivery * intent to seek pediatric care within Nemours/Thomas Jefferson University system * intent to remain in the Philadelphia area for the next 2 years Exclusion Criteria: * inability to speak English * plans to move outside of the Philadelphia area in the next 2 years * plans to not parent infant after delivery * plans to seek pediatric care outside of the Nemours/Thomas Jefferson University System Following a live birth, participants will remain eligible to continue in the study unless the mother or infant experiences the following: gestational age at time of delivery less than or equal to 32 weeks or illness or clinical complication warranting prolonged hospitalization after delivery.
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Vanessa Short, PhD — Thomas Jefferson University
- Study coordinator: Hannah Steiger, PhD
- Email: Hannah.Steiger@jefferson.edu
- Phone: 267-949-6592
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.