Outcome | Instrument | Measure | Description | Method of aggregation | Timepoint |
---|---|---|---|---|---|
Primary outcome | |||||
Child development at 6 months | Bayley Scales of Infant and Toddler Development, Third edition (Bayley III) | The total score from each developmental domain | Bayley III are an individually administered assessment of a child’s attainment of developmental milestones across five domains (i.e. cognitive, language, motor, social–emotional and adaptive skills) [47]. They have been recognised internationally as the most comprehensive tool to assess children from as young as 1 month old and have been validated in South Africa [48] | Individual scores to be compared between intervention and control groups using linear or logistic regression models dependent on the distribution of the data | End point |
Home Screening Questionnaire (HSQ) | HSQ score | The HSQ is a 30-item parent-report tool used to identify features of the home environments related to childhood development [49]. The HSQ has been validated and used for research purposes in a number of countries, including South Africa [50] | Individual scores to be compared between intervention and control groups using linear or logistic regression models dependent on the distribution of the data | End point | |
Secondary outcomes | |||||
Mother/father–infant interaction at 6 months | Mother/father interaction rating scale | Interaction score | Rated from a 5-min videotape of mother/father and infant “talking and playing with each other”, with the infant in a high chair, the mother sitting on a chair at the same height opposite the infant and an attractive stack toy for them to share. We will use an adapted coding scheme developed by Richter et al. to code engagement (eye contact, joint attention), emotional tone, emotional regulation (maternal/paternal comforting for distress), maternal/paternal responsiveness and maternal/paternal scaffolding [51] | Individual scores to be compared between intervention and control groups using linear or logistic regression models dependent on the distribution of the data | End point |
Infant growth at 6 weeks and 6 months | Weight and length | Weight (g) Length (cm) Weight-for-age z-score (WAZ) Length-for-age z-score (LAZ) Weight-for-length z-score (WLZ) | Infant growth will be measured using standard procedures for infant weight and length, and converted to z-scores using the 2006 WHO Growth Standards (WAZ, LAZ and WLZ) | Differences in mean weight and length of infants will be compared between intervention and control groups | Intermediate and end point |
Breastfeeding practices at 6 weeks and 6 months | Maternal self-report questionnaire | Breastfeeding initiation and duration | Information on breastfeeding practices will be collected by trained interviewers using a semi-structured questionnaire | Categorical data will be presented as numbers and percentages. Changes in breastfeeding practices will be compared between intervention and control groups | Intermediate and end point |
Maternal and paternal postnatal depression and anxiety during pregnancy, at 6 weeks and at 6 months | Edinburgh Postnatal Depression Scale (EPDS) | EPDS score | The EPDS is a screening tool for antenatal and postnatal depressive symptoms among women. The EPDS has been validated for use antenatally and postnatally in a number of settings, including South Africa [52, 53] | Proportion of mothers/partners showing signs indicative of depression will be compared during pregnancy, at 6 weeks and at 6 months. Data will be summarised by mean, SD and range at each time point | Baseline, intermediate and end point |
Immunisation status and clinic attendance at 6 weeks and 6 months | Road to Health Booklet (child health record) or maternal/paternal self-report | Clinic attendance at routine child services (immunisation, growth monitoring, developmental screening, vitamin A, deworming). Other health contacts (e.g. sick child care) | Categorical data will be presented as numbers and percentages with comparisons in proportions made at 6 weeks and 6 months | Intermediate and end point | |
Partner involvement during pregnancy, at 6 weeks and at 6 months | Maternal/paternal self-report | Partner involvement in child care | Information on partner involvement in child care will be collected by trained interviewers using a semi-structured questionnaire | Categorical data will be presented as numbers and percentages with comparisons in proportions made at 6 weeks and 6 months | Baseline, intermediate and end point |