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Search / Trial NCT06576323

An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)

Launched by UNIVERSITY OF PENNSYLVANIA · Aug 26, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

The SUPPORT trial is studying how to improve care for mothers dealing with opioid use disorder (OUD) and their newborns who may be experiencing neonatal abstinence syndrome (NAS). The goal is to create a better treatment plan that can be used in neonatal intensive care units (NICUs). To do this, the research team will first talk to mothers and healthcare providers to understand their needs. They will then develop a treatment model that integrates care for both the mother’s substance use and the baby’s withdrawal symptoms, testing it at two partner NICUs to see how well it works and if it's accepted by patients and healthcare providers.

Eligible participants include mothers who have given birth to a baby in the NICU and have been diagnosed with opioid use disorder. Healthcare providers who care for these mothers and their newborns can also take part in interviews. Participants should be comfortable speaking English and have access to a computer or phone. The study aims to ensure that mothers receive the support they need for both their health and their baby’s health, making it easier for everyone involved to navigate this challenging situation. If you or someone you know fits these criteria, this trial could be an opportunity to contribute to important research that may help many families.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria for Interview Participants in Aim 1:
  • Participants should be healthcare providers working within UPHS, who generally treat perinatal women or any individuals with OUD; for the purposes of this study, provider refers to a Medical Doctor (MD) or Doctor of Osteopathy (DO), Advanced Practice Practitioner, Nurse, or Social Worker.
  • Participants should provide direct care to NICU patients and/or their mothers
  • Participants should be proficient in English language
  • Participants should have access to a computer with internet connectivity or phone
  • Inclusion Criteria for Mothers in Aim 1:
  • Participants should be biological mothers of children hospitalized in the UPHS NICU for NAS
  • Participants should be diagnosed with opioid use disorder
  • Inclusion Criteria for Clinicians in Aim 3:
  • See above for inclusion criteria for interview participants.
  • We will use this same criteria to recruit new participants for Aim 3 if the same stakeholder interviewees are unavailable at the time of Aim 3.
  • Inclusion Criteria for Mothers in Aim 3:
  • Participants should be biological mothers of a child hospitalized in either of the two UPHS NICU for NAS (either HUP or PAH)
  • Participants should be no more than 4 weeks postpartum
  • Participants should have an Opioid Use Disorder than is currently untreated with medication assisted treatment or buprenorphine
  • Exclusion Criteria for Interview Participants in Aim 1:
  • - None
  • Exclusion Criteria for Mothers in Aim 1:
  • - None
  • Exclusion Criteria for Clinicians in Aim 3:
  • - None
  • Exclusion Criteria for Mothers in Aim 3:
  • - Active suicidal ideation, or other severe psychopathology that must be addressed before effective MOUD can be prescribed

About University Of Pennsylvania

The University of Pennsylvania, a prestigious Ivy League institution located in Philadelphia, is renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive resources, interdisciplinary expertise, and cutting-edge facilities to conduct innovative studies across various therapeutic areas. With a focus on translating scientific discoveries into clinical applications, the University of Pennsylvania fosters collaborations among leading researchers, clinicians, and industry partners, ensuring rigorous trial design and adherence to ethical standards. Through its dedication to excellence in research and education, the university plays a pivotal role in shaping the future of medicine.

Locations

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Sara Kornfield, PhD

Principal Investigator

University of Pennsylvania

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported