Neonatal Abstinence SyndromeNCT04783558
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
A study testing Mobile-based NAS Caregiving Tool in people with Neonatal Abstinence Syndrome and Opioid-use Disorder, run by Washington State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Abstinence Syndrome, Opioid-use Disorder
- What is being tested?
- Mobile-based NAS Caregiving Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to 13 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Recurring (e.g. daily or almost daily) thoughts of harming themselves or others in the past 2 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University
Spokane, Washington, 99210
About this study
Official title: Effective Caregiving for Neonatal Abstinence Syndrome: Development of an Instructional Mobile Technology Platform for High-Risk Pregnant Women
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.
Read the 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.
- Conditions
- Neonatal Abstinence Syndrome, Opioid-use Disorder
- Being tested
- Mobile-based NAS Caregiving Tool
- Medical subject headings
- Neonatal Abstinence Syndrome, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-based NAS Caregiving ToolBehavioural
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.).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 4, 8, & 12 weeks postpartum
Secondary outcomes (7)
Length of newborn hospital stay
Length of newborn hospital stay will be assessed via a direct question: "how many days did your newborn stay in the hospital"
Measured: 4, 8, & 12 weeks postpartum
Newborn readmission
Newborn hospital readmission will be assessed via direct questions at 3 time points: "has your newborn been readmitted to the hospital in the past 4 weeks for any reason? If yes, how many times in the past 4 weeks? Please list reasons for each readmission in the past 4 weeks"
Measured: 4, 8, & 12 weeks postpartum
maternal postpartum depression
Maternal postpartum depression will be assessed via the PHQ-9, a psychometrically validated 9-item measure used to assess depression in a variety of populations. The PHQ-9 asks participants to report on the degree they were bothered by 9 symptoms over the past 2 weeks (i.e., "little interest or pleasure in doing things", "feeling down, depressed, or hopeless"), with response categories ranging from 0=not at all, to 3= nearly every day, and higher scores indicating greater levels of depression symptomology.
Measured: 4, 8, & 12 weeks postpartum
maternal postpartum stress
Stress will be assessed via the Parenting Stress Index short form (PSI), which measures parental stress associated with the perception of having a difficult child or a dysfunctional parent-child relationship and consists of 36 items that are rated on a 5-point Likert scale (from 1-Strongly Agree to 5-Strongly Disagree) with higher scores indicative of less total stress. PSI has been shown to possess good psychometric properties and has been validated in numerous samples, including high-risk families. It includes Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child subscales, all of which will be considered individually. The Child and Parent domains can and will be combined to form a total stress scale score.
Measured: 4, 8, & 12 weeks postpartum
maternal-infant bonding
Maternal-newborn bonding will be measured via the Maternal Postpartum Attachment Scale (MPAS.) It consists of 19 items assessing three dimensions: pleasure in interaction with the infant (5 items), absence of hostility towards the infant (5 items) and quality of mother-infant attachment (9 items). Response categories range from two-, three-, four- and five-point scales, for different items. The total score ranges from 19 to 95, with higher scores indicating higher maternal postpartum attachment to the baby. The MPAS has been found to have an acceptable level of reliability (Cronbach's alpha ranging from 0.75 to 0.79; test-retest reliability r= 0.86, p<.001).
Measured: 4, 8, & 12 weeks postpartum
breastfeeding
Breastfeeding will be assessed via the following questions: "Are you currently breastfeeding? If yes, "How often do you breastfeed your baby?", if no, "How long did you breastfeed your baby"
Measured: 4, 8, & 12 weeks postpartum
maternal satisfaction with her birth experience
To assess maternal satisfaction with her birth, the Birth Satisfaction Scale-Revised (BSS-R) will be used. The BSS-R is a 10-item, Likert-type, birth satisfaction questionnaire that measures experiences of childbearing, stress, quality of care, and women's attributes, and was psychometrically validated in the US. Its response categories range from 1 = Strongly Disagree, to 5 = Strongly Agree, with higher scores indicating higher birth satisfaction.
Measured: 4, 8, & 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start25 Jul 2024
- Primary completion13 Nov 2026 (estimated)
- Study completion13 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Ekaterina Burduli, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783558
- Sponsor's protocol ID
- K01DA051780
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2021
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual level participant data will be shared with others.
Publications
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.
PubMed 33856360
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Caregiving for Neonatal Abstinence Syndrome: Development of an Instructional Mobile Technology Platform for High-Risk Pregnant Women
- ClinicalTrials.gov ID
- NCT04783558
- Acronym / sponsor ID
- K01DA051780
- Conditions
- Neonatal Abstinence Syndrome, Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 13 Nov 2026 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adapted NAS tool Intervention | Experimental | Behavioral: Mobile-based NAS Caregiving ToolPregnant 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. |
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Recurring (e.g. daily or almost daily) thoughts of harming themselves or others in the past 2 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile-based NAS Caregiving ToolThe 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.). | Behavioural | Adapted NAS tool Intervention |
Primary outcome
Change in maternal drug relapse
Time frame: 4, 8, & 12 weeks postpartum
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.
Change in Opioid use treatment continuation
Time frame: 4, 8, & 12 weeks postpartum
Change in OAT continuation will be assessed via a direct question: "Are you currently receiving OAT (Y/N)? Please explain".
7 secondary outcomes
Length of newborn hospital stay
Time frame: 4, 8, & 12 weeks postpartum
Newborn readmission
Time frame: 4, 8, & 12 weeks postpartum
maternal postpartum depression
Time frame: 4, 8, & 12 weeks postpartum
maternal postpartum stress
Time frame: 4, 8, & 12 weeks postpartum
maternal-infant bonding
Time frame: 4, 8, & 12 weeks postpartum
breastfeeding
Time frame: 4, 8, & 12 weeks postpartum
maternal satisfaction with her birth experience
Time frame: 4, 8, & 12 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 33856360Burduli 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.
- Individual participant dataSharing planned: No. No individual level participant data will be shared with others.
Related trials for Neonatal Abstinence Syndrome
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Recruiting
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
NAS
Recruiting
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Opioid Use Disorder, Neonatal Abstinence Syndrome
Active, not recruiting
Neurostimulation to Improve NOWS Outcomes
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
RecruitingObservational study
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile-based NAS Caregiving Tool in people with Neonatal Abstinence Syndrome and Opioid-use Disorder, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maternal drug relapse (time frame: 4, 8, & 12 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04783558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.