Skip to main content

Table 2 Schedule of enrolment, interventions, and assessments

From: Internet-based behavioural activation to improve depressive symptoms and prevent child abuse in postnatal women (SmartMama): a protocol for a pragmatic randomized controlled trial

   Enrolment Allocation Post-allocation
TIMEPOINT   T0 0 12 weeks follow-up (T1) 24 weeks follow-up (T2)
 Eligibility screen   X    
 Informed consent   X    
 Allocation    X   
 Intervention group      
 Control group      
Co-primary outcomes
 EPDS Maternal depressive symptoms X   X X
 CTS-1 Psychological aggression toward children X   X X
Secondary outcomes
  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
 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 outcome scale for Digital Mental Health (IDMH) for users Acceptability, appropriateness, feasibility, overall satisfaction, and harms    X  
  1. 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