NCT06576323 An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
| NCT ID | NCT06576323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-07-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Sara Kornfield, PhD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT06576323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06576323 currently recruiting?
Yes, NCT06576323 is actively recruiting participants. Contact the research team at sarakorn@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06576323 trial being conducted?
This trial is being conducted at Philadelphia, United States, Philadelphia, United States, Philadelphia, United States.
Who is sponsoring the NCT06576323 clinical trial?
NCT06576323 is sponsored by University of Pennsylvania. The principal investigator is Sara Kornfield, PhD at University of Pennsylvania. The trial plans to enroll 50 participants.