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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• 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.

Locations
United States
Washington
Washington State University
RECRUITING
Spokane
Contact Information
Primary
Ekaterina Burduli, PhD
eburduli@wsu.edu
5093247321
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 30
Treatments
Experimental: Adapted NAS tool Intervention
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.
No_intervention: Treatment-as-Usual (TAU)
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Washington State University

This content was sourced from clinicaltrials.gov