Variable (Measure) | Timing of measures | ||||
---|---|---|---|---|---|
 | Baseline | 6 to 8 weeks post-randomization (pregnancy) | 3 months postpartum | 6 months postpartum | 12 months postpartum |
PHASE I | Â | Â | |||
Demographics (education, income, maternal age at recruitment, ethnicity) (Items from Maternity Experiences Survey, bMES [120]) | X | Â | Â | Â | Â |
Obstetric and medical history (parity, chronic and pregnancy complications, type of delivery, weight - pre-pregnancy, delivery, 6 weeks postpartum) (Items from MES) | X | Â | X | Â | Â |
Mental health history (history of depression, anxiety, stress; age of onset of previous episodes of mental health problems) (Items from MES) | X | Â | Â | Â | Â |
Pharmacologic therapy for depression/anxiety (past; current) (Items from Canadian Community Health Survey, CCHS) | X | X | X | X | X |
Social support (Interpersonal Support Evaluation List, ISEL [121]) | X | X | X | X | X |
Prenatal depression, anxiety, stress symptoms (Depression, Anxiety, and Stress Scale, DASS-21 [107] - presence (percent above cut-off point) and severity (mean score, standard deviation) | X | X | Â | Â | Â |
Postnatal depression, anxiety, stress symptoms (Depression, Anxiety, and Stress Scale, DASS-21 [107] - presence (percent above cut-off point) and severity (mean score, standard deviation) | X | X | X | X | X |
aPsychosocial assessment (Antenatal Risk Questionnaire-Revised, ANRQ-R; includes substance use and violence) [1, 31] | X | X | X | X | X |
Depression (Edinburgh Postnatal Depression Scale, EPDS) [111] | X | X | X | X | X |
aANRQ-R acceptability | X | Â | Â | Â | Â |
Mastery (Pearlin’s Mastery Scale) [122] | X | X | X | X | X |
Self-efficacy (Generalized Self-Efficacy Scale) [123] | X | X | X | X | X |
Self-esteem [124] | X | X | X | X | X |
Resilience (Connor-Davidson Resilience Scale) [91] | X | X | X | X | X |
X | X | X | X | X | |
Parenting competence (Parenting Sense of Competence Scale, PSCS; subscales Efficacy, Interest, Satisfaction) [127] | Â | Â | X | X | X |
Parenting stress (Parental Stress Scale) [128] | Â | Â | X | X | X |
Relationship quality and adjustment (Dyadic Adjustment Scale, DAS-7) [7, 129] | X | X | X | X | X |
Coping (Brief Cope) [130] | X | X | X | X | X |
Maternal-infant attachment (Condon and Corkindale) [131] | Â | Â | X | X | X |
Infant behavior (Infant Behavior Questionnaire) [132] | Â | Â | X | X | X |
Infant development (Ages and Stages Questionnaire, 3rd edition, ASQ-3; The Baby Pediatric Symptom Checklist for Social/Emotional Screening) [91, 133] | Â | Â | X | X | X |
Birth weight (medical record) | Â | Â | X | Â | Â |
Gestational age (medical record) | Â | Â | X | Â | Â |
5-minute Apgar score (medical record) | Â | Â | X | Â | Â |
Other factors related to infant outcomes: feeding method (medical record and parent-report); neonatal/infant health (medical record and parent-report) (Parent report items from the All Our Babies birth cohort studyc) | Â | Â | X | X | X |
Patient diaries [134] (For economic analysis - including health service use, medication use, productivity loss, personal cost) | X | X | X | X | X |
Quality of life (For economic analysis - SF-36,SF-6D to calculate QALY) [135] | X | X | X | X | X |
Efficiency of intervention (percent of women with psychosocial assessment, referral, and care in IG versus CG; self-report and medical record) | Â | Â | X | X | X |
Utility of intervention (one question asked at the end of each cognitive behavior therapy (CBT) homework exercise: This exercise was useful to me with four response options of I strongly agree, I somewhat agree, I somewhat disagree, I strongly agree; one question asked at the end of each CBT module: The information in this module was useful to me with same response options) | Â | X | Â | Â | Â |
Usability of intervention (one question asked at the end of each CBT homework exercise: This exercise was clear and easy to understand with response options; 2 questions asked at the end of each module: 1) The information in this module was clear and easy to understand; 2) It was easy to work through the module (for example, it was easy for me to get from one part to the other, easy to find what I needed) with same response options) | Â | X | Â | Â | Â |
Acceptability: Tablet-based psychosocial assessment (one question at end of completing ANRQ-R: I would recommend a tablet-based approach to asking about emotional health to a pregnant friend with four response options of I strongly agree, I somewhat agree, I somewhat disagree, I strongly agree) | X | Â | Â | Â | Â |
Acceptability: CBT (one question at end of each CBT module: I would recommend this module to a pregnant friend who was struggling with stress, depression, or anxiety with 4 response options of I strongly agree, I somewhat agree, I somewhat disagree, I strongly agree) | Â | X | Â | Â | Â |
Overall assessment (two open-ended questions at the end of every CBT module: 1) The thing I liked most about this module was….; 2) The thing I liked least about this module was….) |  | X |  |  |  |
Log of interactions with participants (completed by research nurse) | X | X | X | Â | Â |
PHASE 2 | Â | Â | |||
Efficiency (Providers’ views of the efficiency of the process of clinic-based online psychosocial assessment) |  |  | X |  |  |
Utility (Women’s views of how useful the modules in were in meeting their needs) |  |  |  |  |  |
Usability (Women’s views of how easy/difficult the modules were to navigate) |  |  | X |  |  |
Feasibility (providers’ views of feasibility of conducting integrated intervention in their setting; women’s views of the feasibility of doing the modules; Google Analytics for example, percent of women accessing CBT within 2 weeks postassessment; percent of women accessing each CBT module within 1 to 2 weeks; percent completion of all six CBT modules; percent completion of CBT modules within 8 weeks) |  |  | X |  |  |
Acceptability (women’s and providers’ views of acceptability/ability to promote disclosure) |  |  | X |  |  |
Mechanisms (women’s views of why and how the intervention did/did not improve outcomes; how the intervention benefitted/did not benefit them) |  |  | X |  |  |