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Table 2 Study outcome measures

From: Health Pregnancy, Healthy Baby: testing the added benefits of pregnancy ultrasound scan for child development in a randomised control trial

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

  1. SD standard deviation, WHO World Health Organization