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Behavioral Intervention

Mobile Technology for Neonatal Abstinence Syndrome Care

N/A
Waitlist Available
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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Change in maternal drug relapse
Secondary outcome measures
Length of newborn hospital stay
Newborn readmission
breastfeeding
+4 more

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.

Find a Location

Who is running the clinical trial?

Washington State UniversityLead Sponsor
102 Previous Clinical Trials
56,770 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,488 Previous Clinical Trials
2,622,622 Total Patients Enrolled
13 Trials studying Neonatal Abstinence Syndrome
1,268 Patients Enrolled for Neonatal Abstinence Syndrome

Media Library

Mobile-based NAS Caregiving Tool (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04783558 — N/A
Neonatal Abstinence Syndrome Research Study Groups: Treatment-as-Usual (TAU), Adapted NAS tool Intervention
Neonatal Abstinence Syndrome Clinical Trial 2023: Mobile-based NAS Caregiving Tool Highlights & Side Effects. Trial Name: NCT04783558 — N/A
Mobile-based NAS Caregiving Tool (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04783558 — N/A
~20 spots leftby May 2025