Sharps 2016.

Study characteristics
Methods	Design: individual and cluster‐RCT. Mothers recruited to the study and nurse home visitors trained to deliver the intervention. Post‐test only survey of mothers in the study Unit of randomisation: urban participants randomised individually; rural participants randomised by cluster‐according to health care agency
Participants	Healthcare provider: home visitors (HV) (community health nurses, community health workers supervised by nurses) Other: pregnant women Location/Setting: 13 rural, midwest and 1 urban east coast health departments in the USA. Training for HV was in the primary care organisation. Intervention for women was delivered in their homes Sample size cluster: n = 13 (intervention group n = 7, control group n = 6) HV: n = 73 (number by trial arm unclear) women n = 239 (intervention group n = 124, control group n = 115) Number of withdrawals/dropouts Cluster: not provided HV: not provided women: n = 131 (intervention n = 73, control n = 58) Sex: not reported Inclusion criteria Home visitors: not reported Women: rural and urban, English‐speaking pregnant women aged 14 years or older, low income, less than 32 weeks gestation, experiencing perinatal IPV by a current or past partner, and enrolled in a perinatal home visiting programme of a participating agency. IPV assessed using Abuse Assessment Scale and Women’s Experience in Battering scale Exclusion criteria: not reported
Interventions	Intervention (n = 124 women) Home visitors: 8 hours of training (2 x 4‐hour training sessions); intervention arm received foundational IPV training session (first 4 hours) then another 4 hours on the Domestic Violence Enhanced Home Visitation Program (DOVE) intervention and study protocol, with role play and class‐based group discussion. Second session reviewed information specific to the research protocol, including screening and assessment instruments, delivering the brochure‐based DOVE intervention, developing safety plans, and appropriate documentation; also had safety protocol training on how to deal with an abuser during the home visit; annual booster training sessions provided Women: DOVE intervention; integrated into existing home visiting programmes. 3 x 15 ‐ 25‐minute DOVE IPV empowerment sessions during women’s pregnancy and 3 during postpartum; each session includes discussion on DOVE brochure addressing the cycle of violence, danger assessment, safety planning information and contact details for community resources/referral Control (n = 115 women) Home visitors: first 4‐hour training session on foundational IPV training only (trained on information about IPV, the importance of screening and intervening) Women: standard home visiting care, with discussion of IPV and supportive care only if indicated
Outcomes	Primary outcomes: IPV, measured using the Conflict Tactics Scale 2; at baseline, women were asked about violence in the past year, and at subsequent data collection time points, asked if these acts had occurred since the previous data collection time point Secondary outcomes: women’s mental health outcomes (actual), measured with the Edinburgh Postnatal Depression Scale (10‐item scale used to measure depressive symptoms in the perinatal period) Timing of outcome assessment: women’s outcomes measured at baseline and 1, 3, 6, 12, 18 and 24 months after delivery
Notes	Study start date: 2006 Study end date: 2014 Funding source: This study was supported by grant (number R01009093) from the National Institutes of Health/National Institute of Nursing Research (NIH/NINR). NIH/NINR had no role or made no contribution to the scientific design of the study, implementation, data collection, or analysis and made no contribution to this article Conflicts of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Randomization procedures varied by site. At the urban health department site, participants were randomized using computer‐generated number assignments in blocks" (p 1131) Comment: Information about rural randomisation not clearly provided Quote: "In the rural sites, there were 13 rural health agencies that participated. Cluster randomization was used to assign seven health agencies to deliver the DOVE intervention and six health agencies were designated as UC. Cluster randomization was necessary in the rural sites because each health agency was small enough that intervention drift was a plausible threat if women were the unit of randomization" (p 1131)
Allocation concealment (selection bias)	Unclear risk	Comment: No information on blinding of those carrying out the random allocation was provided Quote: "The data managers, database development team, and statistical analysis team members were blinded to group assignment" (p 1131)
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: incomplete information provided for urban participants Quote: rural participants ‐ "The data managers, database development team, and statistical analysis team members were blinded to group assignment" (p 1131)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: outcomes were self‐reported by women and hence the risk of bias from lack of masking of assessor was already determined to be low. However, researchers/assessors also appeared to be masked to allocation status Quote:"All data were collected by research nurses who were not associated with delivering the DOVE intervention. There were no changes to study outcome measures after the trial commenced" (p 1132)
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: greater than 20% attrition rate Quote: "239 women were randomized to DOVE (n = 124) or UC (n = 115) and completed the baseline assessment. A proportion (22.6%) of women did not have a chance to complete their 18‐ or 24‐month assessments" (p 1132)
Selective reporting (reporting bias)	Low risk	Comment: results for the primary outcomes mentioned in the Methods section were reported in the paper
Other bias	Low risk	Comment: the study appears to be free from other sources of bias