Table 2.
Outcomes and description of measures.
| Study stage and outcome | Study design | Description of measures | |||
| Stage 1: NASa tool adaptation | |||||
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Tool adaptation | Semistructured interviews | Semistructured interviews with a panel of NAS care experts and mothers with NAS-affected newborns until we reach saturation (expected n=10) to document their perspectives and gather their recommendations on the care of newborns with NAS. | ||
| Stage 2: Usability, acceptability, and feasibility of the adapted NAS tool | |||||
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Usability | Survey | Participants will complete a 10-item SUSb, in which they are asked to answer questions about a mobile app (eg, “I think that I would need the support of a technical person to be able to use this app”) using a 5-point Likert scale, ranging from strongly disagree to strongly agree. The SUS is currently the industry standard for evaluation of a wide variety of products and services such as software, mobile devices, websites, and apps [30,31]. The SUS has been shown to successfully differentiate between usable and unusable systems, and it can be used in small samples with reliable results [30,31]. | ||
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Acceptability | Survey | Acceptability will be examined by the CSQ-8c to rate the overall satisfaction with the adapted NAS tool [29]. CSQ-8 is a validated questionnaire measuring satisfaction with health services (eg, “How would you rate the quality of care your received?”) that has been translated in more than 30 languages [29,32,33]. Possible total scores on CSQ-8 range from 8 to 32, with higher scores (>23) indicating greater satisfaction with health services. | ||
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Feasibility | Survey | To assess feasibility, a measure of utility will be assessed (eg, “To what extent do you expect to be able to incorporate the NAS caregiving tool in your daily activities during pregnancy and postpartum?”), tracking how many times participants referred to specific modules within the mobile tool and open-ended questions that ask participants to comment on feasibility of this tool along with overall impressions and comments. | ||
| Stage 3: Clinical trial comparing NAS tool with usual care | |||||
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Demographic characteristics | Randomized clinical trial | Demographics and baseline characteristics, such as age, education, marital status, time in the OATd program, number and age of living children, employment, and ASI-Litee, will be collected at the start of the study to describe the sample and to serve as control variables when comparing groups on the outcomes. | ||
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Maternal drug use and relapse | Randomized clinical trial | Maternal drug use and relapse will be assessed via ASI-Lite, a standardized semistructured clinical interview that offers clinical information and assesses severity profiles in the following domains: medical, employment, alcohol, drug, psychological, legal, and family and social [34]. It has been shown to have adequate to good internal consistency, good test-retest reliability, independence across the domain composite scores, and agreement with the longer version of the ASI-Lite [34]. | ||
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OAT continuation | Randomized clinical trial | OAT continuation will be assessed via a single question (“Are you currently receiving OAT (Yes or No)? Please explain”). | ||
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Length of newborn hospital stay and readmission | Randomized clinical trial | These will be determined by single questions: length of newborn hospital stay (“how many days did your newborn stay in the hospital”) and newborn hospital readmission (“has your newborn been readmitted to the hospital for any reason after discharge? If yes, how many times? Please list reasons for each readmission”). | ||
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Perinatal maternal-fetal attachment | Randomized clinical trial | Prenatal maternal-fetal attachment will be measured with the Maternal Antenatal Attachment Scale [35,36], a reliable and validated 19-item measure of maternal-fetal attachment that includes several response formats and assesses 2 dimensions: 1) quality of attachment (11 items) and 2) intensity of preoccupation (8 items). The total scores range from 19 to 95, with higher scores indicating a higher level of attachment to the fetus [35-39]. Maternal-newborn bonding will be measured via MPASf [40,41]. It consists of 19 items assessing 3 dimensions: pleasure in interaction with the infant (5 items), absence of hostility toward the infant (5 items), and quality of mother-infant attachment (9 items). Response categories range from 2-, 3-, 4-, to 5-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 α ranging from .75 to .79; test-retest reliability r=0.86; P<.001) [37,40,41]. | ||
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Maternal birth experience | Randomized clinical trial | The Birth Satisfaction Scale-Revised, a 10-item, Likert-type birth satisfaction questionnaire that measures experiences of childbearing, stress, quality of care, and women’s attributes, was psychometrically validated in the United States by our research team [42-44]. Its response categories range from 1=strongly disagree to 5=strongly agree, with higher scores indicating higher birth satisfaction. | ||
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Maternal Depression | Randomized clinical trial | Assess via the PHQ-9g, a psychometrically validated 9-item measure used to assess depression in a variety of populations [45-47]. The PHQ-9 asks participants to report on the degree they were bothered by 9 symptoms over the past 2 weeks (ie, “little interest or pleasure in doing things” and “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. | ||
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Maternal stress | Randomized clinical trial | PSIh 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 [48]. PSI has been shown to possess good psychometric properties and has been validated in numerous samples, including high-risk families [49]. 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. | ||
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Breastfeeding | Randomized clinical trial | Assessed via several questions “Are you currently breastfeeding? If yes, ‘How often do you breastfeed your baby?’, if no, ‘How long did you breastfeed your baby.’” | ||
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Frequency of NAS tool use | Randomized clinical trial | Throughout their third trimester and postpartum, we will also send participants a brief weekly web-based survey link asking about the previous week’s frequency of use of the adapted mobile NAS tool and which specific modules participants viewed most, if any, to track weekly frequency of use and preference of modules. | ||
aNAS: neonatal abstinence syndrome.
bSUS: Systems Usability Scale.
cCSQ-8: 8-item Client Satisfaction Questionnaire.
dOAT: opioid agonist therapy.
eASI-Lite: Addiction Severity Index-Lite.
fMPAS: Maternal Postpartum Attachment Scale.
gPHQ-9: 9-item Patient Health Questionnaire
hPSI: Parenting Stress Index short form.