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Status:

RECRUITING

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

Lead Sponsor:

University of Pennsylvania

Conditions:

Opioid Use Disorder

Neonatal Abstinence Syndrome

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this study is to address the gap in maternal OUD treatment and infant neonatal opioid withdrawal syndrome care. The research team will develop a treatment model and a set of strategies ...

Detailed Description

The increasing prevalence of pregnant and postpartum women affected by Opioid Use Disorder (OUD) in the US is highlighted by the growing number of babies referred to the NICU for Neonatal Abstinence S...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 1 2026

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT06576323

    Start Date

    July 1 2024

    End Date

    June 1 2026

    Last Update

    July 18 2025

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, United States, 19104

    2

    Penn Center for Women's Behavioral Wellness

    Philadelphia, Pennsylvania, United States, 19104

    3

    Pennsylvania Hospital

    Philadelphia, Pennsylvania, United States, 19107