| 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 |
| Cicchetti 2006 |
Some concerns |
Method used to generate random sequence and to conceal allocation are not described: "Following completion of baseline assessments, the mothers and infants recruited for the maltreatment sample were randomly assigned to one of three groups"
No significant differences reported between groups: "The groups did not differ on child gender, maternal age, maternal minority race/ethnicity, current receipt of TANF, total family income, or marital status. However, the average Hollingshead level of education differed between groups, with mothers in the NC group reporting higher level education than mothers in the IPP and CS groups. However, the three maltreatment groups did not differ from each other. Finally, the groups differed on the number of children to whom the mothers had given birth, with mothers in the NC group reporting fewer children than the mothers in each of the maltreatment groups, but the IPP, PPI, and CS groups did not differ from each other" |
High risk of bias |
Participants and people delivering the interventions would have likely been aware of their group allocation due to differences in the interventions
Some deviation from intended intervention: "Mothers assigned to intervention groups who declined to participate in the intervention were added to the control group"
Modified ITT excluding participants with missing outcome data |
Low risk of bias |
8‐33% dropout (from total sample). Unbalanced dropout, large dropout in CS group, only moderate dropout in other conditions and control comparison group
Evidence that the results was not biased by the missing data: "Treatment decliners did not differ from those who engaged in intervention on any demographic variables or baseline measures...Families who were retained versus lost to follow‐up were compared on baseline measures to determine variables that might relate to differential attrition. The groups did not differ on major family demographic variables...The retained and non‐assessed families also did not differ in terms of baseline measures of maternal representations of her own mother in childhood, the experience of maltreatment in her own childhood, parenting attitudes, stress associated with parenting, and social support" |
Low risk of bias |
Subscale of a validated outcome measure used
Same measurement and assessment time points used for all participants
Outcome assessors were blinded to treatment condition: "Children’s attachment at pre‐intervention was coded by two independent, reliably trained raters, who were unaware of children’s maltreatment statuses or intervention group assignments...[at follow‐up] Neither of the coders was aware of children’s maltreatment statuses, treatment conditions, or attachment classifications at previous assessments" |
Some concerns |
No published protocol, no data analysis plan reported in Cicchetti 2006 or Stronach 2013
All reported results correspond to intended outcome measurements |
High risk of bias |
Overall high risk of bias due to no information on the randomization process, deviations from the intended interventions, and insufficient information on the analysis intentions |
| Cicchetti 2006 |
Some concerns |
Method used to generate random sequence and to conceal allocation are not described: "Following completion of baseline assessments, the mothers and infants recruited for the maltreatment sample were randomly assigned to one of three groups"
No significant differences reported between groups: "The groups did not differ on child gender, maternal age, maternal minority race/ethnicity, current receipt of TANF, total family income, or marital status. However, the average Hollingshead level of education differed between groups, with mothers in the NC group reporting higher level education than mothers in the IPP and CS groups. However, the three maltreatment groups did not differ from each other. Finally, the groups differed on the number of children to whom the mothers had given birth, with mothers in the NC group reporting fewer children than the mothers in each of the maltreatment groups, but the IPP, PPI, and CS groups did not differ from each other" |
High risk of bias |
Participants and people delivering the interventions would have likely been aware of their group allocation due to differences in the interventions
Some deviation from intended intervention: "Mothers assigned to intervention groups who declined to participate in the intervention were added to the control group"
Modified ITT excluding participants with missing outcome data |
Low risk of bias |
8‐33% dropout (from total sample). Unbalanced dropout, large dropout in CS group, only moderate dropout in other conditions and control comparison group
Evidence that the results was not biased by the missing data: "Treatment decliners did not differ from those who engaged in intervention on any demographic variables or baseline measures...Families who were retained versus lost to follow‐up were compared on baseline measures to determine variables that might relate to differential attrition. The groups did not differ on major family demographic variables...The retained and non‐assessed families also did not differ in terms of baseline measures of maternal representations of her own mother in childhood, the experience of maltreatment in her own childhood, parenting attitudes, stress associated with parenting, and social support" |
Low risk of bias |
Subscale of a validated outcome measure used
Same measurement and assessment time points used for all participants
Outcome assessors were blinded to treatment condition: "Children’s attachment at pre‐intervention was coded by two independent, reliably trained raters, who were unaware of children’s maltreatment statuses or intervention group assignments...[at follow‐up] Neither of the coders was aware of children’s maltreatment statuses, treatment conditions, or attachment classifications at previous assessments" |
Some concerns |
No published protocol, no data analysis plan reported in Cicchetti 2006 or Stronach 2013
All reported results correspond to intended outcome measurements |
High risk of bias |
Overall high risk of bias due to no information on the randomization process, deviations from the intended interventions, and insufficient information on the analysis intentions |
