Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women

Opioid-use Disorder Clinical Trial

Official title:

Effective Caregiving for Neonatal Abstinence Syndrome: Development of an Instructional Mobile Technology Platform for High-Risk Pregnant Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04783558
• Other study ID #: K01DA051780
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Washington State University
• Contact: Ekaterina Burduli, PhD
• Phone: 5093247321
• Email: eburduli[@]wsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Most newborns experiencing Neonatal Abstinence Syndrome (NAS) require non-pharmacologic care, which entails, most importantly, maternal involvement with her newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies while they are pregnant, yet, an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, in part because no interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. In this project, the investigators propose to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled analog trial.

Description:

Due to an alarming rise in opioid use among the general population that is mirrored in pregnant women, Neonatal Abstinence Syndrome (NAS) rates have increased in the US from 2004 to 2014. Most newborns experiencing NAS require non-pharmacologic care, which entails, most importantly, maternal involvement with her newborn. Facilitating postpartum maternal-newborn involvement is critical in preventing further adverse maternal-newborn outcomes. To achieve positive maternal-newborn involvement, mothers need to learn effective caregiving NAS strategies while they are pregnant. Surprisingly, current obstetrical practice standards for high risk pregnant women do not address this pressing need, in part because no interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. To address this critical gap, the investigators propose to adapt an existing mobile NAS tool for clinician training and decision support, for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled analog trial. First, the investigators will conduct semi-structured interviews with a panel of neonatology experts, NAS care providers, and mothers with NAS-affected babies to gather their recommendations on management of NAS and explore their perspectives on the care of these newborns. Findings will guide the adaptation of the existing mobile NAS tool for high-risk pregnant women. The investigators will then test the usability, acceptability, and feasibility of the adapted mobile tool via surveys with 10 pregnant women receiving opioid agonist therapy (OAT) at Spokane Regional Health District's Opioid Treatment Program and Evergreen Recovery Center. Finally, the investigators will randomize 30 high-risk pregnant women seen at these facilities to either receive the adapted mobile NAS caregiving tool or usual care. The investigators will compare these mothers on maternal drug relapse and OAT continuation, maternal-newborn bonding, length of newborn hospital stays, readmission rates, breastfeeding initiation and duration, and postpartum depression and anxiety at 4, 8, and 12 weeks postpartum. Findings will serve as pilot data for a subsequent large R01 randomized controlled analog trial testing the efficacy of the adapted NAS caregiving tool in reducing poor outcomes for NAS-affected newborns and their mothers.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Pregnant woman in the third trimester currently in OAT treatment for opioid use disorder
• 18 years of age or older
• Ability to speak and understand English.

Exclusion Criteria:

• Recurring (e.g. daily or almost daily) thoughts of harming themselves or others in the past 2 weeks.

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Opioid-Related Disorders
• Opioid-use Disorder
• Syndrome

Intervention

Behavioral:
• Mobile-based NAS Caregiving Tool
The information and skills training in the adapted NAS caregiving tool will be largely based on elements of Eat Sleep Console. Therefore, the NAS mobile tool intervention will incorporate non-intrusive caregiving skills and strategies that encompass providing a low stimulating environment (e.g., dimmed light and low noise), swaddling, continuous comfort and contact with caregiver, skin-to-skin contact, frequent breastfeeding/feeding, as well as novel components identified in the key informant interviews (e.g., preparing for stigma during delivery, CPS involvement, etc.).

Locations

Country	Name	City	State
United States	Washington State University	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Washington State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maternal drug relapse	Change will be assessed via the Addiction Severity Index-Lite (ASI-LITE), a standardized semi-structured clinical interview that offers clinical information and assesses severity profiles in the following domains: medical, employment, alcohol, drug, psychological, legal, and family/social.	4, 8, & 12 weeks postpartum
Primary	Change in Opioid use treatment continuation	Change in OAT continuation will be assessed via a direct question: "Are you currently receiving OAT (Y/N)? Please explain".	4, 8, & 12 weeks postpartum
Secondary	Length of newborn hospital stay	Length of newborn hospital stay will be assessed via a direct question: "how many days did your newborn stay in the hospital"	4, 8, & 12 weeks postpartum
Secondary	Newborn readmission	Newborn hospital readmission will be assessed via direct questions at 3 time points: "has your newborn been readmitted to the hospital in the past 4 weeks for any reason? If yes, how many times in the past 4 weeks? Please list reasons for each readmission in the past 4 weeks"	4, 8, & 12 weeks postpartum
Secondary	maternal postpartum depression	Maternal postpartum depression will be assessed via the PHQ-9, a psychometrically validated 9-item measure used to assess depression in a variety of populations. The PHQ-9 asks participants to report on the degree they were bothered by 9 symptoms over the past 2 weeks (i.e., "little interest or pleasure in doing things", "feeling down, depressed, or hopeless"), with response categories ranging from 0=not at all, to 3= nearly every day, and higher scores indicating greater levels of depression symptomology.	4, 8, & 12 weeks postpartum
Secondary	maternal postpartum stress	Stress will be assessed via the Parenting Stress Index short form (PSI), which measures parental stress associated with the perception of having a difficult child or a dysfunctional parent-child relationship and consists of 36 items that are rated on a 5-point Likert scale (from 1-Strongly Agree to 5-Strongly Disagree) with higher scores indicative of less total stress. PSI has been shown to possess good psychometric properties and has been validated in numerous samples, including high-risk families. It includes Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child subscales, all of which will be considered individually. The Child and Parent domains can and will be combined to form a total stress scale score.	4, 8, & 12 weeks postpartum
Secondary	maternal-infant bonding	Maternal-newborn bonding will be measured via the Maternal Postpartum Attachment Scale (MPAS.) It consists of 19 items assessing three dimensions: pleasure in interaction with the infant (5 items), absence of hostility towards the infant (5 items) and quality of mother-infant attachment (9 items). Response categories range from two-, three-, four- and five-point scales, for different items. The total score ranges from 19 to 95, with higher scores indicating higher maternal postpartum attachment to the baby. The MPAS has been found to have an acceptable level of reliability (Cronbach's alpha ranging from 0.75 to 0.79; test-retest reliability r= 0.86, p<.001).	4, 8, & 12 weeks postpartum
Secondary	breastfeeding	Breastfeeding will be assessed via the following questions: "Are you currently breastfeeding? If yes, "How often do you breastfeed your baby?", if no, "How long did you breastfeed your baby"	4, 8, & 12 weeks postpartum
Secondary	maternal satisfaction with her birth experience	To assess maternal satisfaction with her birth, the Birth Satisfaction Scale-Revised (BSS-R) will be used. The BSS-R is a 10-item, Likert-type, birth satisfaction questionnaire that measures experiences of childbearing, stress, quality of care, and women's attributes, and was psychometrically validated in the US. Its response categories range from 1 = Strongly Disagree, to 5 = Strongly Agree, with higher scores indicating higher birth satisfaction.	4, 8, & 12 weeks postpartum