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

July 15, 2025 updated by: University of Pennsylvania

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Syndrome after birth. Despite recent advances in integrating mental health and substance abuse treatment into adult healthcare settings, no current treatment options exist to integrate maternal OUD treatment and referrals into the pediatric care setting making it unlikely that mothers will be able to access care. In order to preserve the dyadic bond, improve maternal functioning, and provide a more stable environment for the infant after discharge from the NICU, the researchers now embark on a study utilizing steps from intervention mapping to identify facilitators and barriers to integrated maternal OUD treatment and referral in the NICU, adapt existing evidence-based models of co-located OUD care to the NICU setting, and test the feasibility and acceptability of the new model. In Aim 1, the researchers will collect qualitative data via in-depth interviews with 32 NICU providers, social workers, administrators, and parents to determine barriers and facilitators to offering bedside buprenorphine induction and treatment. In Aim 2, the researchers will convene an advisory board to review data collected in Aim 1 and to develop a plan for implementing buprenorphine initiation into the study's unique setting to address the issue- the provision of adult focused OUD care in a pediatric care setting. Aim 2 does not constitute Human Subjects research. The primary outcome of Aim 2 will be a suite of implementation strategies to pilot test in Aim 3. Aim 3 is a pilot case series implementation trial where the researchers will test the adapted intervention to determine feasibility and acceptability to both providers and patients. As this is a case series the investigators propose to recruit 10 participants from each of the two partner NICUs for a total enrollment of N= 20 in Aim 3. A formal sample size calculation was not performed as there is no data on which to a base a formal sample size calculation. For pilot studies with an expected medium standardized effect size, a case number of N= 15 per group has been recommended for pilot studies preceding a possible main study with a power of 90%. The investigators plan to recruit 20 participants to account for possible attrition. The researchers are not necessarily powered to detect an effect. Participants will not be randomized to condition; all NICU mothers meeting inclusion criteria during the study timeline for Aim 3 will be invited to participate in Aim 3. The outcomes of acceptability and feasibility will be measured through questionnaires, interviews, and treatment initiation and retention statistics.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Pennsylvania Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Case Series
In Aim 3, all recruited participants will receive the intervention.
Behavioral: An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU
We will use implementation mapping to develop a suite of implementation strategies to deliver evidence-based MOUD prescription to mothers attending the bedside of their infants hospitalized in the NICU. The intervention itself is buprenorphine induction and treatment, however the model for delivery is not yet developed, consistent with the need for results from Aim 1 to inform the approach used to develop the implementation model in Aim 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Interview for NICU Providers
Time Frame: Time 1 (baseline)
In-depth qualitative interview focused on providers' attitudes and knowledge about barriers and facilitators of buprenorphine induction for mothers in the NICU. This interview will be guided by the Consolidated Framework for Implementation Research to query about barriers and facilitators of MOUD provision in the NICU, with the primary goal of identifying contextual determinants of co-located care.
Time 1 (baseline)
Qualitative Interview for Parents
Time Frame: Time 1 (baseline)
In-dept qualitative interview focused on mothers' attitudes about receiving MOUD in the NICU while caring for their hospitalized infant. This interview will be guided by the Consolidated Framework for Implementation Research to query about what would make this more attractive, feasible, and engagement more likely.
Time 1 (baseline)
Feasibility of Intervention Measure
Time Frame: Up to 9 months
A 4-item,psychometrically-validated measure that indexes the extent to which stakeholders perceive an implementation strategy is feasible.
Up to 9 months
Acceptability of Intervention Measure
Time Frame: Up to 9 months
A 4-item,psychometrically-validated measure that indexes the extent to which stakeholders perceive an implementation strategy is acceptable.
Up to 9 months
Recruitment and Retention Statistics
Time Frame: Up to 1 year.
The proportion of mothers of babies in the NICU who agree to receive MOUD in the NICU (Time 2; T2), who remain in care for the duration of their baby's stay (Time 3; T3), and length of time they remain in outpatient treatment after treatment (Time 4; T4).
Up to 1 year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics survey
Time Frame: Time 1 (baseline)
Brief questionnaire about provider and parent demographic (e.g., age, gender) and professional characteristics (e.g., provider role, years of experience, level of training), and work setting
Time 1 (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Sara Kornfield, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21DA058815 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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