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

University of Pennsylvania · NCT06576323

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
50
US sites recruiting
3
Study start
July 1, 2024
Record last updated
July 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 to provide evidence-based OUD treatment to postpartum mothers in NICUs.

First, the investigators will conduct a needs assessment via in-depth qualitative interviews with NICU mothers and clinicians. Then, with the expertise of the advisory board, the the researchers will create a protocol for implementing maternal OUD treatment at the NICU bedside. The researchers will then implement the protocol in two partner NICUs and evaluate the acceptability and feasibility to patients, providers, and clinical, and administrative leaders.

The goal of this research study is to integrate maternal mental health and substance abuse treatment in pediatric settings and to refine, test, and examine the acceptability and feasibility of applying the adapted model.

Being studied: An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU

Conditions: Opioid Use Disorder; Neonatal Abstinence Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Hospital of the University of Pennsylvania

    Philadelphia, PA 19104

  • Penn Center for Women's Behavioral Wellness

    Philadelphia, PA 19104

    Site contact: Sara Kornfield, PhD · 215-746-1255 · sarakorn@pennmedicine.upenn.edu

  • Pennsylvania Hospital

    Philadelphia, PA 19107

Study contacts (from the official record)

  • Sara Kornfield, PhD · 215-746-1255 · sarakorn@pennmedicine.upenn.edu
  • Emma Farber, BA · 215-746-3338 · emma.farber@pennmedicine.upenn.edu
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An Intervention Mapping Approach to Closing the Gap in Maternal… (NCT06576323) | Bored Studies