Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I) |
The depression module will be used to indicate presence of postpartum depression. |
3 months postpartum |
|
| Secondary |
Postpartum depression as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I) |
The depression module will be used to indicate presence of postpartum depression. |
12 months postpartum |
|
| Secondary |
Maternal knowledge of depression, postpartum depression and antidepressant use during pregnancy |
True/false knowledge questionnaire. |
baseline and 4 weeks |
|
| Secondary |
Decisional conflict as measured by the Decisional Conflict Scale (DCS) |
DCS consists of 16 items each rated 1-5 where scores = 25 represent delayed and ineffective decisions. |
throughout pregnancy (up to 9 months) |
|
| Secondary |
Maternal depression as measured by the Edinburgh Postnatal Depression Scale (EPDS) |
EPDS is a 10-item self-report scale. Each item is scored 0-3 with scores >12 being predictive of a diagnosis of depression. |
throughout pregnancy and up to 1 year postpartum (up to 21 months) |
|
| Secondary |
Maternal anxiety as measured by the Spielberger State-Trait Anxiety Inventory (STAI) |
STAI is a 40-item self-report scale with good discriminate validity in perinatal populations. Each item is scored 1-4 with scores >48 being predictive of an anxiety disorder diagnosis. |
throughout pregnancy and up to 1 year postpartum (up to 21 months) |
|
| Secondary |
Maternal quality of life as measured by the 12-item Short Form (SF-12) Health Survey |
SF-12 is a 12-item survey used to estimate the quality-adjusted life year (QALY) which incorporates both length of life and quality of life into a single measure. The measure includes a physical component summary and a mental component summary score. It is scored 0-100 with higher scores indicating better physical and mental health. |
throughout pregnancy and up to 1 year postpartum (up to 21 months) |
|
| Secondary |
Study website metrics to inform if patterns of PDA use are predictive of clinical outcomes |
Data generated by the website to inform how participants interact with the PDA: 1) proportion of participants who login to the PDA; 2) timing from enrollment to first login; 3) total number of PDA logins; 4) number of logins between each study time point; 5) proportion of participants who completed the PDA; 6) timing of enrollment to first completion of PDA; 7) number of logins required prior to first completion of PDA; 8) total number of PDA completions; 9) number of PDA completions between each study time point; 10) mean (SD) number of pages viewed per login; 11) whether or not each page was viewed; 12) whether or not each page was viewed between study time points; 13) whether or not each interactive tag was interacted with; 14) whether each interactive tag was interacted with between study time points |
throughout pregnancy (up to 9 months) |
|
| Secondary |
Health service utilization |
1) direct medical costs; 2) indirect medical costs; 3) productivity loss due to patient and family work absence |
throughout pregnancy and up to 1 year postpartum (up to 21 months) |
|
| Secondary |
Pregnancy complications and neonatal outcomes |
Self-reported pregnancy complications and neonatal infant characteristics |
1 month postpartum |
|
| Secondary |
Infant Outcomes as measured by the Infant Characteristics Questionnaire (ICQ) |
ICQ is a 27-item questionnaire with each item scored 1-7. Higher scores indicate higher parental perceptions of difficult infant temperament. |
3-12 months after birth |
|
| Secondary |
Child Development as measured by the Ages and Stages Questionnaire (ASQ-3) |
ASQ-3 is a 30-item instrument that screens for child development from 1 to 60 months. Items are scored as 0, 5 or 10 points. Higher scores indicate that the child is doing well. |
3-12 months after birth |
|
| Secondary |
Parenting stress measured by the Parenting Stress Index (PSI) short form |
The PSI-SF is a 36-item measure consisting of 3 subscales (parental distress, dysfunction in parent-child relations, difficult child). Each item is scored 1-5 with higher scores indicating higher levels of parenting stress. PSI reports subscales separately and also reports a total measure. |
1 month postpartum to 1 year postpartum |
|
| Secondary |
Partner relationship outcomes measured by the Dyadic Adjustment Scale (DAS) |
DAS is a self-report measure of relationship adjustment. An abbreviated version of this scale consisting of only the dyadic consensus subscale will be used. Each item is scored 0-5 with higher scores indicating a higher level of agreement amongst couples. |
throughout pregnancy and up to 1 year postpartum (up to 21 months) |
|
| Secondary |
Bipolar disorder as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I) |
The bipolar disorders module will be used. |
3 months and 12 months postpartum |
|
| Secondary |
Schizophrenia and other psychotic disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I) |
The schizophrenia and other psychotic disorders module will be used. |
3 months and 12 months postpartum |
|
| Secondary |
Anxiety disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I) |
The anxiety disorders module will be used. |
3 months and 12 months postpartum |
|
| Secondary |
Obsessive-compulsive and related disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I) |
The obsessive-compulsive and related disorders module will be used. |
3 months and 12 months postpartum |
|
| Secondary |
Feeding and eating disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I) |
The feeding and eating disorders module will be used. |
3 months and 12 months postpartum |
|
