Risk of bias for analysis 2.12 Psychological interventions vs inactive control, Outcome 4: Parent relationship quality, at post‐intervention.
| 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 | |
| Ammerman 2016 | Some concerns | Method used to generate random sequence is adequate, authors do not specify how the list was created (i.e., computer generated by independent statistician): "Randomization schedule was stratified by race and home visiting model...the randomization schedule was prepared prior to the start of the study and assignments were placed in separate envelopes that were opened sequentially."
Methods used to conceal allocation not fully described. Although envelopes were opened sequentially, no indication that the envelopes were sealed or opaque, so assignment of envelopes without appropriate safegaurds. No significant differences reported between groups |
Low risk of bias | Psychological intervention, likely both participants and intervention providers would be aware of intevention assignment "because some 'home visitors' had mothers in both IH‐CBT and HV conditions, there is a risk of contamination...unlikely that this was a significant concern given the robustness of the superiority of IH‐CBT...none of the home visitors were taught CBT strategies and it is improbable that they would acquire such skills simply by having mothers in treatment" pg 370 Ammerman 2013 No evidence of depatures from usual care, as part of usual care participants were permitted to access treatment outside of the trial, aligning with standard practice. Modified ITT in which participants with missing outcome data were excluded | Low risk of bias | Unpublished data from authors for the trauma exposed subsample shows moderate dropout for intervention group. IH‐CBT: 14% dropout, Home visiting: 5% dropout Low attrition. Comparing effects in ITT data and subgroup data based on modified ITT exluding those with missing data, analysis shows very little difference in M and SD. "dropout was unrelated to initial MDD severity, recurrent vs. single episode MDD, or psychiatric comorbidity (p < .05)." | Some concerns | Validated measure used Each group had same assessments. The ISEL is a self‐report outcome, the participant is the assessor so 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 recieved | Low risk of bias | No published protocol. Analysis plan provided in report. Reported results correspond to intended outcome measures Reported results crrespond to intended analyses | Some concerns | Overall some concerns due to no information about allocation concealment and the potential bias in the measurement of outcome (self‐report) |