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Table 2 Secondary outcomes

From: An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the Insika Yomama cluster randomised controlled trial

 

Domain

Measure

Metric

Method of aggregation

Timepoint

1

Maternal depression

Edinburgh Postnatal Depression Scale (EPDS), total score

Mean difference

Mean and SD

End of pregnancy; 24 months postnatal

2

Maternal anxiety

Generalized Anxiety Disorder 7-item (GAD-7) scale, total score

Mean difference

Mean and SD

End of pregnancy, 24 months postnatal

3

Maternal antiretroviral treatment adherence

Viral Suppression (Yes/No)

Risk ratio

Frequency and percentage

End of pregnancy; 12 weeks, 12 months, 24 months postnatal

4

Exclusive breastfeeding

Exclusive breastfeeding at 6 months (Yes/No)

Risk ratio

Frequency and percentage

6 months postnatal

5

Adherence to infant immunisation schedule over the 24-month postnatal period

No. of immunisations recorded

Mean difference

Mean and SD

12 weeks, 12 months, 24 months postnatal

6

Infant diarrhoea

Any maternal report of diarrhoea over the previous 14 days.

Risk ratio

Frequency and percentage

12 weeks, 6 months, 12 months, 24 months postnatal

7

Cognitive and emotional stimulation within the home environment

Early Childhood Development section of Multiple Indicator Cluster Surveys (MICS6) Questionnaire for cognitive and emotional stimulation for children under five, total score

Mean difference

Mean and SD

12 months, 24 months postnatal

8

Infant behaviour

Parenting Stress Index, Short Form (PSI/SF: parent-child dysfunctional interaction subscale and difficult child subscale, total score

Mean difference

Mean and SD

12 months postnatal

 

Externalising subscale of Child Behaviour Checklist (CBCL), total score

Mean difference

Mean and SD

24 months postnatal

9

Child language development

Language subscale of the Bayley Scales of Infant and Toddler Development III (BSID-III), Composite score

Mean difference

Mean and SD

24 months postnatal

10

Child growth (infant height and weight at 24 months)

Road to Health Book, study Weight and height measurements

Mean difference

Mean and SD

24 months postnatal