Table 3.
Outcomes and timing of assessments
| Study variable | Instrument | Outcome (range) |
|---|---|---|
| Maternal: measured at baseline and 3a-, 6-, and 12-month post-randomization | ||
| Maternal characteristicsb | Trial Baseline Questionnaire [54, 55] | Self-reported age, education level, gender and sexual orientation, marital status, race, immigrant status and ethnicity, clinical history with depression or anxiety (severity, chronicity, number of prior episodes, and age at first episode), occupational status, number of children, pregnancy intention, pregnancy history, delivery, and birth. |
| Depressive symptoms | Edinburgh Postnatal Depression Scale (EPDS) [44] | Mean continuous score of a 10-item scale (0–30) |
| Anxiety symptoms | Generalized Anxiety Disorder Scale (GAD-7) [45] | Mean continuous score of a 7-item scale (0–21) |
| Response and remission | Patient Health Questionnaire-9 (PHQ-9) [56] |
Response: PHQ < 10 Remission is defined as PHQ < 5 |
| Perceived support | Multidimensional Scale of Perceived Social Support [57] | Mean continuous score of a 12-item scale (1–84) |
| Disability assessment | World Health Organization Disability Assessment Schedule (WHODAS) [58] | Mean continuous score of a 12-item scale (0–48) |
| Quality of life assessment | EQ 5D-5 Level [59] | Mean continuous score of a 5-item scale (1–25) |
| Trauma symptoms | Abbreviated PTSD Checklist (PCL-6) [60] | Mean continuous score of a 6-item scale (1–30) |
| Patient-reported activation | Premium Abbreviated Activation Scale [41, 61] | Mean continuous score of a 5-item scale (0–20) |
| Patient satisfactionc | Client Satisfaction Questionnaire-8 (CSQ-8) [62] | Mean continuous score of an 8-item scale (1–32( |
| Therapeutic alliancec | Working Alliance Inventory-Short Revise (WAI-SR) [63] | Mean continuous score of a 12-item scale (1–60) |
| Health service utilization | Health Service Utilization Form | Total score of a 16-item scale (0–32) |
| Treatment preferenceb | Delivery of treatment and treatment provider preference | Score of 0 or 1 |
| COVID-19 exposure | 1-item question on COVID-19 exposure | Self-reported |
| Treatment: measured at every session during treatment, unless otherwise indicated | ||
| Dosage | Treatment log [64] | Frequency of sessions attended |
| Therapy qualityd | Quality of Healthy Activity Program (Q-HAP) [51] | Mean continuous score of treatment-specific BA skills (0–4) and general counseling skills (0–4) |
| Session depressive/anxiety | Session-by-session EPDS [44] and GAD-7 [45] scores | Mean continuous score of a 10-item scale (0–30) on EPDS and of a 7-item scale (0–21) on GAD-7 |
| Homework adherence | Treatment log [64] | Mean continuous score of a 1-item question (0–2) |
| Adverse or serious AEs | Anytime an adverse event (AE) or serious AE occurs | Any event that represents a series threat to the safety of the mother or her child |
| Health service utilization | Health Service Utilization Form [65] | Total score of a 16-item scale (0–32) |
| List of medications | List of medications | Self-reported list of medications |
| COVID-19 exposure | 1-item question on COVID-19 exposure | Self-reported |
| Child: measured at 9 to 15 months post-child birth unless otherwise indicated | ||
| Birth weight and length | Retrieved from hospital chart or self-reporte | Assessed at birth |
| Breastfeeding | Whether breastfeeding and if stopped age stopped [55]. | Total number of months (0–12) |
| Psychosocial stimulation | Home Observation Measurement Evaluation [66] | Total score of a 45-item checklist |
| Mental development | Bayley Mental Development Scales IV [67] | Mean continuous score of cognitive, receptive, and expressive language development |
aAssessment period will be extended to account for post-treatment outcomes when there are perinatal-related interruptions to treatment (e.g., giving birth, obstetrical complications, COVID-19)
bOnly at baseline
cMeasured at 3 months post-randomization only
dRandomly selected for supervision, rated by self, peers, expert supervisor
eSelf-report will be used when hospital charts are outside of the recruiting site