NCT04783558|Active Not Recruiting
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Sponsor study identifier
NIH
interventional
30
1 country
1
Study Start
July 25, 2024
Actual (reported)Primary Completion
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 22, 2021
Actual (reported)March 5, 2021
Actual (reported)July 25, 2024
Actual (reported)November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Length of newborn hospital stay
4, 8, & 12 weeks postpartum
Newborn readmission
4, 8, & 12 weeks postpartum
maternal postpartum depression
4, 8, & 12 weeks postpartum
maternal postpartum stress
4, 8, & 12 weeks postpartum
maternal-infant bonding
4, 8, & 12 weeks postpartum
Pregnant women in this condition will receive the adapted mobile-based NAS instructional tool and TAU. Women in this condition will go through the NAS instructional tool at least once during pregnancy, with their choice of going through the modules gradually while waiting at the OAT clinic to receive their dose, or by scheduling a time to review the modules. Participants will have free online access to the tool throughout their third trimester as well as through 12-weeks postpartum so they can access the modules at any time, and as many times as desired, including after giving birth.
Pregnant women in this condition will receive care as usual that involves continued enrollment in OAT and continued obstetric care. We will also provide them with a printed handout containing information on NAS and local resources. Participants in the TAU condition will not receive iPads with accompanying modules, however the handout constitutes more information than they normally receive.
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.).
Washington State University
Spokane, Washington, 99210, United States
Burduli E, Jones HE, Brooks O, Barbosa-Leiker C, Johnson RK, Roll J, McPherson SM. Development and Implementation of a Mobile Tool for High-Risk Pregnant Women to Deliver Effective Caregiving for Neonatal Abstinence Syndrome: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Apr 15;10(4):e27382. doi: 10.2196/27382.
First Submitted
January 22, 2021
Contact the study team to confirm eligibility.
First Posted
March 5, 2021
Study Start
July 25, 2024
Actual (reported)Primary Completion
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 13, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
No individual level participant data will be shared with others.
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