Clinical trial NCT04783558: Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Official title: Effective Caregiving for Neonatal Abstinence Syndrome: Development of an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Abstinence Syndrome
Opioid-use Disorder
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-03-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pregnant women in the Treatment-as-Usual (TAU) condition will receive care as usual that involves continued enrollment in treatment and continued obstetric care. Participants will also be provided with a printed handout containing information on NAS and local resources. Pregnant women in the Adapted NAS tool Intervention 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. Women will be randomized 1:1 to the intervention or TAU conditions.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in maternal drug relapse
timeFrame: 4, 8, & 12 weeks postpartum
measure: Change in Opioid use treatment continuation
timeFrame: 4, 8, & 12 weeks postpartum
Secondary outcomes:
measure: Length of newborn hospital stay
timeFrame: 4, 8, & 12 weeks postpartum
measure: Newborn readmission
timeFrame: 4, 8, & 12 weeks postpartum
measure: maternal postpartum depression
timeFrame: 4, 8, & 12 weeks postpartum
measure: maternal postpartum stress
timeFrame: 4, 8, & 12 weeks postpartum
measure: maternal-infant bonding
timeFrame: 4, 8, & 12 weeks postpartum
measure: breastfeeding
timeFrame: 4, 8, & 12 weeks postpartum
measure: maternal satisfaction with her birth experience
timeFrame: 4, 8, & 12 weeks postpartum
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University
state: Washington
Study officials:
References:
citation: 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.