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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 belowSelect...
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
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 moreTrial 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.
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Who is running the clinical trial?
Washington State UniversityLead Sponsor
101 Previous Clinical Trials
56,684 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,603 Total Patients Enrolled
13 Trials studying Neonatal Abstinence Syndrome
1,268 Patients Enrolled for Neonatal Abstinence Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You have had frequent thoughts of hurting yourself or others in the last two weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment-as-Usual (TAU)
- Group 2: Adapted NAS tool Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the target outcome of this medical experiment?
"The key outcome of this research, which will be surveyed over the course of 4, 8 and 12 weeks after birth is the alteration in maternal substance abuse. Subsidiary objectives include mother-child bonding (as determined by the Maternal Postpartum Attachment Scale), breastfeeding habits and newborn readmission to hospital."
Answered by AI
Does this research study allow those aged 55 and over to participate?
"This medical study seeks to include participants aged 18 and younger than 99 years old."
Answered by AI
Does the protocol for this experiment still accept new participants?
"According to information on clinicaltrials.gov, this particular medical study is no longer recruiting patients as the most recent update was issued on March 2nd 2021. The initial posting of this trial took place September 1st 2022 and at present there are 1680 other active trials seeking participants."
Answered by AI
Do I qualify to engage in this clinical experiment?
"This clinical trial is recruiting 30 patients, aged 18-99 years old and struggling with passive addiction. In order to participate, individuals must meet the minimum age requirement of 18 or older."
Answered by AI
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