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. 2021 Apr 20;21:314. doi: 10.1186/s12884-021-03767-9

Table 2.

Schedule of enrolment, interventions, and assessments

Enrolment Allocation Post-allocation
TIMEPOINT T0 0 12 weeks follow-up (T1) 24 weeks follow-up (T2)
ENROLMENT:
 Eligibility screen X
 Informed consent X
 Allocation X
INTERVENTIONS:
 Intervention group
 Control group
ASSESSMENTS: Aim
Co-primary outcomes
 EPDS Maternal depressive symptoms X X X
 CTS-1 Psychological aggression toward children X X X
Secondary outcomes
Maternal
  PHQ-9 Depresssive symptoms X X X
  PSI-SF Parent stress X X X
  MIBS-J Mother-to-infant bonding X X X
  EQ-5D-5L Quality of life X X X
  Use of inpatient and outpatient medical care in the past 3 months Medical cost X X X
Paediatric
 Height, body weight Physical development X X X
 Type of nutrition (breast milk, formula, both, baby food) Nutritional status X X X
 Attendance of well-baby visits at 1, 3, 6–7, 9–10 months) Health check-up status X X X
 Immunization record (Hib, pneumococcus, DPT-IPV, rotavirus, BCG) Immunization status X X X
 Use of inpatient and outpatient medical care for injuries, foreign body ingestion, burn, and drowning in the 3 months Medical cost for injuries X X X
Implementation
 Implementation outcome scale for Digital Mental Health (IDMH) for users Acceptability, appropriateness, feasibility, overall satisfaction, and harms X

EPDS Edinburgh Postnatal Depression Scale, CTS-1 Conflict Tactics Scale, PHQ-9 Patient Heatlh Questionnaire-9, PSI-SF Parent stress index-short form Japanese version, MIBS-J Mother-to-Infant Bonding Scale Japanese version, EQ-5D-5L EuroQol-5 dimension-5 level