Risk of bias for analysis 1.15 Socio‐ecological outcomes (connection to community professionals) ‐ secondary outcome.
| Study | Bias | |||||||||||
| Randomisation process | Deviations from intended interventions | Missing outcome data | Measurement of the outcome | Selection of the reported results | Overall | |||||||
| Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | |
| Rosenblum 2017 | Some concerns | Method used to generate random sequence is adequate, however unclear how they concealed allocation, as no details provided on who called the participant informing them of their allocation, and how that individual received allocation information: "Women were randomized using a computer‐generated algorithm (urn randomization stratified by baseline trauma exposure and depression to ensure balanced groups to either the multifamily group [treatment condition] or mailing group [control condition])." No significant differences reported between groups: "Women in both conditions were balanced on demographic, mental health and trauma variables" | Low risk of bias | Participants and people delivering the interventions would have likely been aware of their group allocation due to differences in the interventions No deviation from intended intervention specified, unlikely that the outcome would be impacted by lack of blinding Modified ITT excluding participants with missing outcome data | Some concerns | 36‐37% dropout (from total sample) No evidence that the results was not biased by the missing data, however no analysis method or sensitivity analysis to correct for bias Reasons for dropout are not reported, however dropout is equal between groups | Some concerns | Validated outcome measure used Same measurement and assessment time points used for all participants Measurement tool is self‐report, so participants are assessors and cannot be blinded The outcome assessment could be potentially influenced by the knowledge of the intervention received. It is unlikely that the reporting was influenced by the treatment received | Some concerns | No published protocol, however outcomes in methods section align with those in the results Insufficient detail on analysis intentions, there is likely more than one way in which the outcome measurement could have been analysed | Some concerns | Method used to generate random sequence is adequate, however unclear how they concealed allocation, as no details provided on who called the participant informing them of their allocation, and how that individual received allocation information: "Women were randomized using a computer‐generated algorithm (urn randomization stratified by baseline trauma exposure and depression to ensure balanced groups to either the multifamily group [treatment condition] or mailing group [control condition])."
No significant differences reported between groups: "Women in both conditions were balanced on demographic, mental health and trauma variables" Participants and people delivering the interventions would have likely been aware of their group allocation due to differences in the interventions No deviation from intended intervention specified, unlikely that the outcome would be impacted by lack of blinding Modified ITT excluding participants with missing outcome data 36‐37% dropout (from total sample) No evidence that the results was not biased by the missing data, however no analysis method or sensitivity analysis to correct for bias Reasons for dropout are not reported, however dropout is equal between groups Validated outcome measure used Same measurement and assessment time points used for all participants Measurement tool is self‐report, so participants are assessors and cannot be blinded The outcome assessment could be potentially influenced by the knowledge of the intervention received. It is unlikely that the reporting was influenced by the treatment received No published protocol, however outcomes in methods section align with those in the results Insufficient detail on analysis intentions, there is likely more than one way in which the outcome measurement could have been analysde |