Kiely 2010.

Methods	A complex RCT with several arms and 4 different interventions targeting women with risk factors (depression, smoking, passive smoking and IPV). Women may have had more than 1 risk factor and may have been randomised to receive more than 1 intervention. Women at risk of IPV were randomised into intervention and control arms.
Participants	Setting: 6 community prenatal clinics serving mainly African‐American women in Washington DC. July 2001‐2003. Inclusion criteria: women from minority groups (mainly African‐American) aged at least 18 years, 28 weeks pregnant or less, English speaking and resident in the study area. Exclusion criteria: women who were identified as suicidal at baseline or follow‐up were excluded.
Interventions	Experimental intervention: cognitive behavioural intervention focusing on 4 risk factors (smoking, passive smoking, depression and DV). Women received an intervention specifically focusing on their individual risk factors (most women had more than one risk factor and would receive more than 1 intervention component. 336 women reported DV and 169 were randomised to the DV intervention group. The intervention was delivered as part of routine prenatal visits by psychologists or social workers. The intervention was based on empowerment theory and emphasised safety planning and behaviours and a list of phone numbers for community resources was provided. The intervention took place over several sessions lasting about 30 minutes and women received a small incentive for attending sessions. There were 2 postpartum booster sessions to reinforce messages. 51% of women in the intervention group received 4 or more sessions and a quarter attended none. Comparison group: 167 of the women reporting DV received standard care according to protocols at each clinic.
Outcomes	DV was identified by Abuse Assessment Screen at baseline. Follow‐up sessions used Conflict Tactics Scale to identify women at risk. Episodes of DV during pregnancy and in the early postpartum period (minor and severe and sexual violence). Low and very low birthweight, gestational age at delivery, preterm and very preterm birth.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation scheme with site and risk specific permuted block randomisation with investigators and staff blinded to block size.
Allocation concealment (selection bias)	Low risk	Allocation by external data co‐ordinating centre by telephone.
Incomplete outcome data (attrition bias) All outcomes	High risk	More than 1000 women were recruited to this trial and randomised. Randomisation was stratified according to baseline risk and only those women with DV risk were randomised for the DV intervention. (In this review we have reported findings for those women identified at risk of DV and randomised to receive or not receive the DV intervention; If we carried out analysis using all women randomised any intervention effect would be diluted considerably). 336 with DV risk had baseline data but there were considerable amounts of missing data at follow‐up, although there were some outcome data for at least 1 of the follow‐up interviews for 306 women and outcome data for babies were available for 306 women. It was reported that women were analysed by randomisation group whether or not they received the planned intervention.
Selective reporting (reporting bias)	Unclear risk	Most women had more than 1 risk factor and were likely to receive different interventions – the interventions may have had some synergistic or interactive effect. But results are reported only by single risk factors – i.e. this paper only focuses on women reporting DV at baseline.
Other bias	Unclear risk	Intervention and control group characteristics appeared similar at baseline. It was no clear how many woman received multiple interventions or whether women in the control group received other interventions to address risk factors other than DV.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Women and staff delivering intervention would be aware of group assignment. Telephone interviewers were reported to be blind to allocation but it was not clear whether this was successful (women may have revealed their allocation during interviews).
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Women and staff delivering intervention would be aware of group assignment. Telephone interviewers were reported to be blind to allocation but it was not clear whether this was successful (women may have revealed their allocation during interviews).