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An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full 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 the study
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.
What is being tested
- An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU (behavioral)
Sponsor: University of Pennsylvania · Participants: 50 · Started: Jul 1, 2024
Contact the study team
- Sara Kornfield, PhD · Phone: 215-746-1255
- Emma Farber, BA · Phone: 215-746-3338
Official record on ClinicalTrials.gov — NCT06576323
Locations in the U.S.
| Pennsylvania | Hospital of the University of Pennsylvania, Philadelphia Penn Center for Women's Behavioral Wellness, Philadelphia Pennsylvania Hospital, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.