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

NCT04783558 | Active Not Recruiting

• 1 other identifier: K01DA051780
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Abstinence Syndrome; Opioid-use Disorder

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• 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

Study Arms (2)

Adapted NAS tool Intervention

EXPERIMENTAL

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.

Behavioral: Mobile-based NAS Caregiving Tool

Treatment-as-Usual (TAU)

NO INTERVENTION

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.

Interventions

Mobile-based NAS Caregiving Tool BEHAVIORAL

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.).

Adapted NAS tool Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Washington State University

Spokane, Washington, 99210, United States

Location

Related Publications (1)

• 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.

  PMID: 33856360 DERIVED

MeSH Terms

Conditions

Neonatal Abstinence Syndrome; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Women will be randomized 1:1 to the intervention or TAU conditions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: March 5, 2021
• Study Start: July 15, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)