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Behavioral Intervention

Mobile Technology for Neonatal Abstinence Syndrome Care

N/A

Recruiting

Research Sponsored by Washington State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4, 8, & 12 weeks postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a mobile tool to help high-risk pregnant women learn about and care for newborns with Neonatal Abstinence Syndrome.

Who is the study for?

This trial is for English-speaking pregnant women in their third trimester who are currently receiving treatment for opioid use disorder. It's not suitable for those with frequent recent thoughts of self-harm or harming others.

What is being tested?

The study is testing a mobile tool designed to educate high-risk pregnant women on caring for newborns with Neonatal Abstinence Syndrome (NAS) to improve mother-newborn interactions.

What are the potential side effects?

Since the intervention involves educational content delivered via a mobile platform, there are no direct medical side effects associated with its use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4, 8, & 12 weeks postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4, 8, & 12 weeks postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 8, & 12 weeks postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Change in maternal drug relapse

Secondary study objectives

Length of newborn hospital stay

Newborn readmission

breastfeeding

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adapted NAS tool InterventionExperimental Treatment1 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.

Group II: Treatment-as-Usual (TAU)Active Control1 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.

0 / 1Eligibility criteria met