Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576323
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care SUPPORT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPPORT
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
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
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 studys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None