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. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

Risk of bias for analysis 3.11 Depressive symptoms at 0‐1 months.

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
Acarturk 2022 Low risk of bias 1.1: Y. Quote: "Participants were randomly assigned either to the Self‐Help Plus arm or to ECAU only, in a 1:1 ratio." 1.2: Y. Quote "The randomization schedule was generated by Castor Electronic Data Capture (EDC). (..) Research team members involved in
recruitment were able to access the web‐based software to randomize each newly enrolled participant, but were not able to access the randomization list, and were not aware of the block size."
1.3: N. Note: No significant differences at baseline.		 Low risk of bias 2.1: PY; 2.2: PY. Note: Due to the nature of the intervention participants and the interventionists were most likely aware of the allocation.
2.3: PN. Note: No evidence to suggest issues to implement intervention.
2.4: NA.
2.5: NA.
2.6: Y. Quote: "We followed an intent‐to‐treat approach for analysis of primary and secondary outcomes"
2.7: NA.		 Low risk of bias 3.1: PY. Quote: " The distribution of participants lost to follow‐up was similar between the study groups (15.53% vs. 14.06%)"
3.2: NA.
3.3: NA.
3.4: NA.		 Some concerns 4.1: N. Note: The selected outcome method (PHQ‐9) is widely validated and established.
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control.
4.3: PY. Note: Outcome assessors (participants) were most likely aware of intervention allocation.
4.4: PY; 4.5: PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: PY. Note: no evidence to suggest otherwise, methods and results do not show discrepancies.
5.2: PN. Note: No evidence to suggest outcome selection. All outcomes mentioned in the methods are reported.
5.3: PN. Note: No evidence to suggest analyses selection. All analyses mentioned in the methods were reported.		 Some concerns The study is judged to raise some concerns in one domain (4), but not to be at high risk of bias for any domain.
Asnani 2021 Low risk of bias 1.1: Y; 1.2: Y. Note: Quote: "A random numbers
table, computer generated by an independent staff statistician, was kept centrally. Once baseline
measurements were completed, the study coordinator telephoned the central site for the
next assignment based on the random number table and informed the subject of her allocation
group. Th"
1.3: PN. Note: Baseline characteristics were overall comparable across groups, significant differences were reported for 2 variables (compatible with chances)		 Low risk of bias 2.1: PY; 2.2: PY. Note: Due to the nature of the intervention participants and personnel were most likely aware of their assigned intervention
2.3: PN. Note: No evidence to suggest issues to implement intervention. Some changes were made to the protocol before recruitment. These are reported in the manuscript.
2.4: NA.
2.5: NA.
2.6: Y. Quote: "Analyses were performed based on intention to treat principles"
2.7: NA.		 Low risk of bias 3.1: Y. Note: Data was availalble for all 64 randomized participants, there were no losses at the 6 months follow‐up.
3.2: NA.
3.3: NA.
3.4: NA.		 Some concerns 4.1: PN. Note: The selected outcome method (CES‐D) is widely validated and established and demonstrated good inter‐item reliability in the study (0.9)
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control.
4.3: PY. Note: Outcome assessors (participants) were most likely aware of intervention allocation. Staff involved in data collection was blinded to the allocation.
4.4: PY; 4.5: PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: PY. Note: No evidence to suggest otherwise, methods and results do not show discrepancies.
5.2: PN. Note: No evidence to suggest outcome selection. All outcomes mentioned in the methods are reported. Authors mention that the CES‐D was not initially planned to be an outcome of interest in the study, this was added in a second moment, but still before the beginning of recruitment.
5.3: PN. Note: No evidence to suggest analyses selection. All analyses mentioned in the methods were reported.		 Some concerns The study is judged to raise some concerns in one domain (4), but not to be at high risk of bias for any domain.
Baumgartner 2021 Low risk of bias 1a.1: PY; 1a.2: PY. Researchers performed stratified constrained randomization. This was carried out through software. Quote: "Constrained randomization was implemented using the cvcrand Stata package by the US‐based team". 1a.3: NI. No useful information is reported to evaluate this element. 1b.1: PN. It appears the randomization was conducted prior to the recruitment of participants: 1b.2: PN. It is unlikely that the selection of individual participants was affected by knowledge of the intervention assigned to the cluster. 1b.3: PN. There were some baseline imbalances that were compatible with chance, there is no evidence to indicate differential identification or recruitment of individual participants. Some concerns 2.1 a: NI; 2.1b: PY; 2.2: PY. No information was provided on whether participants knew that they were in a trial, due to the nature of the intervention they (as those delivering the intervention) were most likely aware of intervention allocation. 2.3: PY. The low literacy of the lay providers could have impacted implementation fidelity. Quote: "This strategy supported the potential sustainability of the intervention but came with literacy challenges for delivering the iMBC content with full fidelity". 2.4: PN. No evidence to suggest deviations from the intended intervention would have influenced the outcomes. 2.5: NA. 2.6: PY. Data were analysed for most randomized participants. 2.7: NA. Low risk of bias 3.1a: PY. All included clusters were analyzed. 3.1b: PY. Data were available for nearly all participants within the cluster. Quote: "303 (81%), 313 (83.7%), and 266 (71.1%) participants were followed up at the mini‐survey, imme‐ diate post‐intervention survey (follow‐up 1), and the 8‐month post‐ intervention survey (follow‐up 2) time points, respectively ". 3.2: NA. 3.3: NA. 3.4: NA. Some concerns 4.1: N. The outcome measure is well established and reported good psychometric properties in this sample. 4.2: PN. No evidence to suggest differences in measurement between intervention and control. 4.3A: NI; 4.3b: PY. No information provided on whether participants knew that they were in a trial, participants (outcome assessors) were most likely aware of the group allocation due to the nature of the intervention. 4.4: PY; 4.5: PN. Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did. Low risk of bias 5.1: PY. No evidence to suggest otherwise, methods and results do not show discrepancies. 5.2: PN. No evidence to suggest outcomes selection. All outcomes mentioned in the methods and results were reported. 5.3: PN. No evidence to suggest analyses selection. All outcomes mentioned in the methods and results were reported. Some concerns The study is judged to raise some concerns in two domains (2 and 4), but not to be at high risk of bias for any domain.
Chaharrahifard 2021 Low risk of bias 1.1: Y. Note: Title mentions RCT design; Quote: "the samples were randomly assigned to two groups of received counseling (intervention) and non‐received counseling (control) by four‐sized randomized blocks."
1.2: Y. Quote: "The details of blocks were contained in asset of sealed.
1.3: N. Quote: "There was not significant difference between the demographic characteristics in the control and intervention group."		 Some concerns 2.1: PY; 2.2: PY. Note: Due to the nature of the intervention, participants and the interventionists were most likely aware of the allocation.
2.3: PN. No evidence to suggest issues to implement intervention.
2.4: NA
2.5: NA
2.5: NI. Note: No explicit mention of the analysis used to estimate the effect of assignment to intervention.
2.6: N. Note: There was not a substantial impact of the failure to analyse participants in the group to which they were randomized.		 Low risk of bias 3.1: PY. Note: Drop‐out rate: 21%.
3.2: NA
3.3: NA
3.4: NA		 Some concerns 4.1: N. Note: The selected outcome method (EPDS) is widely validated and established.
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control.
4.3: PY. Note: Outcome assessors (participants) were most likely aware of intervention allocation.
4.4: PY; 4.5: PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: PY. Note: No evidence to suggest otherwise, methods and results do not show discrepancies.
5.2: PN. Note: No evidence to suggest outcome selection. All outcomes mentioned in the methods and results were reported.
5.3: PN. Note: No evidence to suggest analyses selection. All outcomes mentioned in the methods and results were reported.		 Some concerns The study is judged to raise some concerns in two domains (2 and 4), but not to be at high risk of bias for any domain.
Chang 2015 Low risk of bias 1.1: Y; 1.2: PY. Note: Title mentions RCT design. Quote: "The evaluation was a cluster randomized trial conducted in Jamaica, Antigua, and St Lucia with public health center as the unit of randomization."
1.3: N. Note: Quote: "There were no significant differences between groups in enrollment characteristics"		 High risk of bias 2.1a: NI; 2.1b: PY; 2.2: PY. Note: No information provided on wheter participants knew that they were in a trial, due to the nature of the intervention they (as those delivering the intervention) were most likely aware of intervention allocation.
2.3: PY. Note: Quote: "Clinics were often noisy and crowded, and some mothers would have had
difficulty hearing and seeing the films. It also made it difficult for the health workers to interact
with the mothers during the
demonstration."
2.4: NA.
2.5: NA.
2.6: Y. Quote: "Analyses were by intention to treat"
2.7: NA.		 Low risk of bias 3.1a: NI. No information on wheter data was available for all clusters. 
3.1b: PY.
3.2: PY. Quote: "Loss did not differ by group (16% of children were lost to follow‐up in the control and 14% were lost to follow‐up in the intevrention)"
3.3: NA.
3.4: NA.		 Some concerns 4.1: N. Note: The selected outcome measure (center for Epidemiologic Studies‐depression Scale) is widely validated and established.
4.2: PN. Note: No evidence to suggest differences in measurements between intevrention and control.
4.3a: PY; 4.3b: PY. Note: Interviewers and testers were blind to center assignment but participants (mothers) probably knew that they were in a trial and participants were most likely aware of the group allocation due to the nature of the intervention. Self‐assessment scale.
4.4: PY; 4.5: PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcome, but there is no reason to believe that it did		 Low risk of bias 5.1: PY. Note: no evidence to suggest otherwise, methods and results do not show discrepancies.
5.2: PN. Note: No evidence to suggest outcome selection. All outcomes mentioned in the methods are reported.
5.3: PN. Note: No evidence to suggest analyses selection. All analyses mentioned in the methods were reported.		 High risk of bias The study is judged to be at high risk of bias in one domain (2).
Chew 2018 Low risk of bias 1a.1: Y; 1a.2: PY. Note: Title mentions RCT design. 
Quote: "In assigning the HCs to the VEMOFIT group (VG) or attention‐control groups (AG), randomisation will be carried out after stratification by cluster size and geographical areas of the 10 HCs."
Quote: "A member of the Data Management Services team at the University Medical center, Ultrecht will carry out the randomisation."
1.3: NI. Note: No useful information is reported to evaluate this element
1b.1: PY. Seems that participants were recruited after randomization.		 Low risk of bias 2.1a: PY. 2.1b: PN. Quote: "We use a modified informed consent procedure to ensure that patients are unware of the two different intervention programmes".
2.2.: Y. Nurses were trained to deliver the intervention.
2.3: PN. Note: No evidence to suggest deviations from the intended intervention that arose because of the trial context.
2.4: NA.
2.5: NA.
2.6: Y. Note: The analysis was carried out on an intention to treat basis.
2.7: NA.		 Low risk of bias 3.1a: PY. All 10 clusters that recruited participants were analyzed. 
3.1b: PN. 92 from intervention group (n = 145) and 79 from control group (n = 150) did not receive allocated intervention. In addition to the 33 people lost to follow up at 12 months, 5 additional missing data were noted with regard to PHQ‐9.
3.2: PN. No evidence that the result was not biased by missing data.
3.3: PN; 3.4: NA. Note: Missingness in the outcome do not depend on its true value.		 Low risk of bias 4.1: N. Note: The selected outcome method (Malay Brief Illness Perception Quetsionnaire, MBIPQ) is validated and established.
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control
4.3a: PY.Outcome assessors (participants) were most likeley aware that a trial was taking a place.
4.3b: PN. Quote: "We use a modified informed consent procedure to ensure that patients are unware of the two different intervention programmes"
4.4: NA.
4.5: NA.		 Low risk of bias 5.1: PY. Note: Protocol is available.
5.2: PN. Note: No evidence to suggest outcome selection. Almost all outcomes mentioned in the methods and protocol were reported (It is not reported "heath‐care utilization hospital" that is a secondary outcome).
5.3: PN. Note: No evidence to suggest analyses selection. All outcomes mentioned in the methdis and protocol were reported.		 Low risk of bias The study is judged to be at low risk of bias for all domains.
Escolar 2014 Some concerns 1.1: Y; 1.2: NI. Quote: "The respondents were then randomly assigned to either the experimental or control group" No information provided about allocation concealment.
1.3: PN. Note: No significant differences at baseline.		 Some concerns 2.1: PY; 2.2: PY. Note: Due to the nature of the intervention participants and the interventionists were most likely aware of the allocation.
2.3: NI. Note: No information provided.
2.4: NA.
2.5: NA.
2.6: NI. Note: No infomation provided.
2.7: N. Note: No drop‐out.		 Low risk of bias 3.1: Y. Note: No missing data.
3.2: NA.
3.3: NA.
3.4: NA.		 Some concerns 4.1: N. Note: The selected outcome method (PHQ‐9) is widely validated and established.
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control.
4.3: Y. Note: Only self‐reported measure.
4.4: PY; 4.5: PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: PY. Note: No protocol available. No evidence to suggest otherwise, methods and results do not show discrepancies.
5.2: PN. Note: No evidence to suggest outcome selection. All outcomes mentioned in the methods are reported.
5.3: PN. Note: No evidence to suggest analyses selection. All analyses mentioned in the methods were reported.		 Some concerns The study is judged to raise some concerns in three domains (1, 2, 4), but not to be at high risk of bias for any domain.
Ferreira‐Vorkapic 2018 Low risk of bias 1.1: Y; 1.2: Y. Quote: "(...) volunteers were randomly allocated to one of the three experimental groups. A separate examiner coordinated the group distribution (and all statistical analysis was performed by an expert from another
state), using the random allocation method."
1.3: N. Quote: "the baseline data showing no significant differences between the groups, except for education years, where the relaxation group showed a higher
level of education"		 Some concerns 2.1: PY; 2.2: PY. Note: Due to the nature of the intervention participants and personnel were most likely aware of their assigned intervention
2.3: PN. Note: No evidence to suggest issues to implement intervention
2.4: NA.
2.5: NA.
2.6: NI. Note: No explicit mention of the analysis used to estimate the effect of assignment to intervention
2.7: NA. Note: There was not a substantial impact of the failure to analyse participants in the group to which they were randomized		 Low risk of bias 3.1: Y. Note: Drop‐out: 0
3.2: NA.
3.3: NA.
3.4: NA.		 Some concerns 4.1: N. Note: The selected outcome method (BAI) is widely validated and established across multiple languages.ility in the study (0.9)
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control.
4.3: PY. Note: Outcome assessors (participants) were most likely aware of intervention allocation.
4.4: PY; 4.5: PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: PY. Note: No evidence to suggest otherwise, methods and results do not show discrepancies.
5.2: PN. Note: No evidence to suggest outcome selection. All outcomes mentioned in the methods and results were reported.
5.3: PN. Note: No evidence to suggest analyses selection. All analyses mentioned in the methods were reported.		 Some concerns The study is judged to raise some concerns in two domains (2 and 4), but not to be at high risk of bias for any domain.
Gao 2015 Low risk of bias 1.1: Y. Quote: "The randomization sequence was generated using a computerized random number generator and the allocation was kept in sealed opaque consecutively numbered envelopes."
1.2.: Y. Quote: "This simple randomization scheme was independently prepared by a research assistant who was not involved in determining eligibility, providing care, or assessing outcome."
1.3: N. Quote: "There were no significant differences between the two groups in their demographic, obstetric and related characteristics (...) There were also no significant differences between the two groups in their baseline measures"		 Low risk of bias 2.1: PY; 2.2: PY. Note: Due to the nature of the intervention, participants and the interventionists were most likely aware of the allocation.
2.3: PN. Note: No evidence to suggest issues to implement intervention.
2.4: NA
2.5: BA
2.6: Y. Note: Intention to treat analysis done.
2.7: NA		 Low risk of bias 3.1: PY. Note: Drop‐out: 14 of 180.
3.2: NA
3.3: NA
3.4: NA		 Some concerns 4.1: N. Note: The selected outcome method (EPDS) is widely validated in Chinese mothers and established.
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control.
4.3: PY. Note: Outcome assessors (participants) were most likely aware of intervention allocation.
4.4.: PY; 4.5: PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: PY. Note: No evidence to suggest otherwise, methods and results do not show discrepancies.
5.2: PN. Note: No evidence to suggest outcome selection. All outcomes mentioned in the methods and results were reported.
5.3: PN. Note: No evidence to suggest analyses selection. All outcomes mentioned in the methods and results were reported.		 Some concerns The study is judged to raise some concerns in one domain (4), but not to be at high risk of bias for any domain.
Hinton 2021 Low risk of bias 1a.1: PY. 1a.2: Y. Quote: "Randomizationwas at the level of clusters, defined as geographic areas (ie, communes) served by commune health stations which have a population
range of ≈5000‐15,000 people. Randomization was conducted
by one of the study investigators residing in the United States through
the flip of a coin."
1a.3: NI. No useful information is reported to evaluate this element
1b.1: N. Note: particpants were recruited after randomization;
1b.2: PN. Note: there is no evidence to suggest that selection of individual participants was affected by knoweldge of the intervention assigned to the cluster;
1b.3:N. Note: no significant differences at baseline were identified.		 Low risk of bias 2.1a: NI; 2.1b: PY; 2.2: Y. Note: No information provided on whether participants knew that they were in a trial, due to the nature of the intervention they (as those delivering the intervention) were most likely aware of intervention allocation.
2.3: PN. Note: No evidence to suggest deviations from the intended intervention that arose because of the trial context
2.4: NA.
2.5: NA.
2.6: Y. Note: Data was analysed on an intention‐to‐treat basis.
2.7: NA.		 Low risk of bias 3.1a PY. Note: no evidence to suggest failure in analyzing any clyster;
3.1b: PY. Note: data was avaiable for 85% of participants at follow‐up.
3.2: NA.
3.3: NA; 3.4: NA.		 Some concerns 4.1: PN. The outcome measure (CES‐D) is widely established and used across contexts.
4.2: PN. Note: no evidence to suggest that.
4.3a: NI; 4.3b: PY. Note: No information provided on whether participants knew that they were in a trial, participants were most likely aware of the group allocation due to the nature of the intervention.
4.4: PY; 4.5: PN. Note: Knowledge of the assigned interventio could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: Y. Note: A pre‐determined statistical plan is avaiable and in line with procedures reported in the final manuscript
5.2: PN. Note:No evidence to suggest outcome selection. All outcomes mentioned in the protocol, methods and results were reported.
5.3: PN. Note: No evidence to suggest analyses selection. All analyses mentioned in the protocol, methods and results were reported.		 Some concerns The study is judged to raise some concerns in one domain (4), but not to be at high risk of bias for any domain.
Lachman 2017 Low risk of bias 1.1: Y; 1.2:Y. Quote: "An external researcher not directly involved in the study conducted the randomization procedures remotely in Oxford, United
Kingdom. Participants were randomly assigned on a 1:1 ratio to an intervention or wait‐list control group after baseline data collection
using a concealed computerized program, SealedEnvelope™."; "Our implementing partner, Clowns Without Borders South Africa, notified participants of their
allocation status via telephone."
1.3:PN.		 Low risk of bias 2.1:Y; 2.2:Y. Quote: "Although program implementers and participants were aware of their allocation status, researchers
conducting self‐report interviews and observational assessments were blind to allocation."
2.3: PN. Note: No evidence to suggest issues to implement intervention
2.4:NA.
2.5:NA.
2.6:Y. Quote: "Data analyses were conducted with an intention‐to‐treat design"
2.7:NA.		 Low risk of bias 3.1:Y. Note: 3 out of the 68 participants randomized were lost at follow‐up (2.9%).
3.2:NA.
3.3:NA.
3.4:NA.		 Some concerns 4.1:PN. Note: The selected outcome method is widely validated and established, appropriate for the local context, and assessed in its psychometric properties for this sample.
4.2:PN. Note: No evidence to suggest differences in measurement between intervention and control.
4.3:Y. Note: Outcome assessors (participants) were most likely aware of intervention allocation. The research assistants administering the questionnaires were blinded.
4.4: PY; 4.5:PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did		 Some concerns 5.1:PY. Note: No evidence to suggest otherwise, the protocol and manuscript do not show discrepancies.
5.2: PY. Note: A few of the secondary outcomes mentioned in the protocol (e.g. ASSIST, Grover‐Counter Scale of Cognitive Development) were not reported in this manuscript.
5.3: PN. Note: No evidence to suggest analyses selection. All analyses mentioned in the protocol and methods were reported in the results.		 Some concerns The study is judged to raise some concerns in two domains (4 and 5), but not to be at high risk of bias for any domain.
Lachman 2020 Low risk of bias 1a.1: Y; 1a.2: Y. Quote: "Cluster randomisation was conducted at village level prior to baseline assessments, to reduce the likelihood of contamination between arms. An external researcher used concealed computer‐generated codes to randomly allocate eight villages into three treatment arms and a control arm "; "The implementing partner notified the participating families of their allocation status after baseline data collection."
1a.3: NI. No useful information is reported to evaluate this element.
1b.1: PN. Note: randomization was conducted prior to the recruitment of participants
1b.2: PN. Note: groups were comparable at baseline, see Table 1.		 Low risk of bias 2.1a: NI; 2.1b: PY; 2.2: PY. Note: No information provided on whether participants knew that they were in a trial, due to the nature of the intervention they (as those delivering the intervention) were aware of intervention allocation.
2.3: PN. Note: No evidence to indicate deviations from protocol.
2.4: NA.
2.5: NA.
2.6: Y. Note: Data was analysed on an intention‐to‐treat basis.
2.7: NA.		 Low risk of bias 3.1a.: Y. Note: all included clusters were analyzed; 3.1b: PY. Note: data were available for nearly all participants within the cluster. Quote:"Study retention was considerably higher than anticipated with 94.8% adults (n=235/248), 87.5% children (n=154/176) and 87.8% in their early childhood (n=122/139) assessments completed at post‐treatment, with no differences between arms "
3.2: NA.
3.3: NA.
3.4: NA.		 Some concerns 4.1: PN. Note: The outcome measure is widely established and validated for use across different contexts.
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control.
4.3a: NI; 4.3b: PY. Note: No information provided on whether participants knew that they were in a trial, participants (outcome assessors) were most likely aware of the group allocation due to the nature of the intervention.
4.4: PY; 4.5: PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: PY. Note: No evidence to suggest otherwise, methods and results do not show discrepancies.
5.2: PN. Note: No evidence to suggest outcomes selection. All outcomes mentioned in the methods and results were reported.
5.3: PN. Note: No evidence to suggest analyses selection. All outcomes mentioned in the methods and results were reported.		 Some concerns The study is judged to raise some concerns in one domain (4), but not to be at high risk of bias for any domain.
Luoto 2020 Low risk of bias 1a.1: PY; 1a.2: PY. Quote: "Using a random
number generator in Stata, two authors (JEL and ILG) randomly assigned villages in a 1:1:1 ratio to one of three study groups, stratified by sub‐county"
1a.3: NI. No useful information is reported to evaluate this element.
1b.1: Y. Note: from protocol it is clear that recruitment of both adults and children as well as baseline assessments, took place before randomization to study arms		 Low risk of bias 2.1 a: NI; 2.1b:PY; 2.2: PY. Note: No information provided on whether participants knew that they were in a trial, due to the nature of the intervention they (as those delivering the intervention) were most likely aware of intervention allocation. Quote: "Due to the nature of the intervention, masking of
participants and community health volunteers who
delivered the intervention was not possible"
2.3: PN. Note: No evidence to suggest deviations from the intended intervention that arose because of the trial context.
2.4: NA.
2.5: NA.
2.6: Y. Note: Data was analysed on an intention‐to‐treat basis.
2.7: NA.		 Low risk of bias 3.1a PY. Note: all 60 clusters that recruited participants were analyzed;
3.1b: PY. Note: 92 participants out of 1152 were lost at followup (8%).
3.2: NA.
3.3: NA; 3.4: NA.		 Some concerns 4.1: PN. The outcome measure (CES‐D) is widely established and used across contexts.
4.2: PN. Note: No evidence to suggest that measurement or ascertainment of the outcome differed between intervention groups.
4.3a: NI; 4.3b: PY. Note: No information provided on whether participants knew that they were in a trial, participants (outcome assessors) were most likely aware of the group allocation due to the nature of the intervention. Efforts were made to keep the data collection teams as masked to group status as possible.
4.4: PY; 4.5: PN. Note: Knowledge of the assigned interventio could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: PY. Note:No evidence to suggest otherwise, protocol and paper do not show discrepancies.
5.2: PN. Note:No evidence to suggest outcome selection. All outcomes mentioned in the protocol, methods and results were reported.
5.3: PN. Note: No evidence to suggest analyses selection. All analyses mentioned in the protocol, methods and results were reported.		 Some concerns The study is judged to raise some concerns in one domain (4), but not to be at high risk of bias for any domain.
Rodriguez 2021 Low risk of bias 1.1: Y. Note: Title mentions RCT design. Quote: "Students who completed the web‐based baseline assessment measures were randomly assigned to a brief, 4‐week internet‐based mindfulness intervention (MIND), or to the intervention plus peer counselor support (MIND+)."
1.2: Y. Quote: "The randomization sequence was sourced through random.org [49], an automated, web‐based randomization service that generates randomness using atmospheric noise. Using random.org, two 25‐person blocks were used to randomize the participants into 2 equally‐sized groups."
1.3: PN. Note: No significant differences at baseline.		 Some concerns 2.1: PY; 2.2: PY. Note: Due to the nature of the intervention, participants and the interventionists were most likely aware of the allocation.
2.3: PN. Note: No evidence to suggest issues to implement intervention.
2.4: NA
2.5: NA
2.6: NI. Note: No explicit mention of the analysis used to estimate the effect of assignment to intervention.
2.7: N. Note: There was not a substantial impact of the failure to analyze participants in the group to which they were randomized.		 High risk of bias 3.1: PN. Note: Drop‐out: 31 of 54.
3.2: PN. Note: Proportions of lost to follow‐up between control and intervention are not comparable (n= 20 and n= 11).
3.3: NI; 3.4: NI. Note: No information about documented reasons that withdrawal are related to the outcome.		 Some concerns 4.1: N. Note: The selected outcome method (PHQ‐9) is widely validated and established.
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control.
4.3: PY. Note: Outcome assessors (participants) were most likely aware of intervention allocation.
4.4: PY; 4.5: PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: PY. Note: No evidence to suggest otherwise, methods and results do not show discrepancies.
5.2: PN. Note: No evidence to suggest outcome selection.
5.3: PN. Note: No evidence to suggest analyses selection.		 High risk of bias The study is judged to be at high risk of bias in one domain (3).
Sangraula 2020 Low risk of bias 1a.1: PY. 1a.2: PY. Quote: "A randomization procedure was used, in which names of the two VDCs were written on cards and placed into a hat. The District Public Health Officer (DPHO) was to draw one card from the hat which would be allocated as the intervention arm VDC and the VDC in the remaining card would be allocated to the control arm. Program staff, including community psychosocial workers (CPSWs) and research assistants (RAs) were only assigned to either VDC after the random drawing to reduce risk of unblinding.
1a.3: PN. There is no evidencde to suggest problems in the randomization process
1b.1: PN. it appears the randomization was conducted prior to the recruitment of participants.
1b.2: PN. It is unlikely that the selection of inidividual participants was affected by knowledge of the intervention assigned to the cluster.
1b.3: PN. there is no evidence to indicate imbalances in baseline values to indicate differentail identification or recruitment of individual participants.		 Low risk of bias 2.1 a:NI. 2.1b: PN. 2.2: PN. Quote: "CPSWs, RAs, trial participants, and local mhGAP trained health workers were blinded to the allocation of the study conditions. The VDCs of the two arms were separated by another VDC which worked as a buffer and physical barrier against contamination between the two arms. CPSWs in both arms were instructed not to disclose the treatment that any participants received except with their clinical supervisors. The trial statistician was blinded to treatment arm during analysis. "
2.3: NA.
2.4: NA.
2.5: NA.
2.6: PY. Data was analysed for most participants randomized.		 Low risk of bias 3.1a: Y. all included clusters were analyzed;
3.1b: PY. data were available for nearly all participants within the cluster
3.2: NA.
3.3: NA.
3.4: NA.		 Low risk of bias 4.1: PN. The outcome measure (PHQ‐9) is widely established and used across contexts, included the one of the trial
4.2: PN. No evidence to suggest that measurement or ascertainment of the outcome differed between intervention groups.
4.3a:NI. 4.3b: PN. No information provided on whether participants knew that they were in a trial, participants (outcome assessors) were blinded		 Low risk of bias 5.1: PY. No evidence to suggest otherwise, protocol and paper do not show discrepancies.
5.2: PN. No evidence to suggest outcome selection. All outcomes mentioned in the protocol, methods and results were reported.
5.3: PN. No evidence to suggest analyses selection. All analyses mentioned in the protocol, methods and results were reported.		 Low risk of bias The study is judged to be at low risk of bias for all domains.
Song 2019 Low risk of bias 1.1: Y; 1.2: PY. Note: Block randomization, computer‐generated random list. Using opaque and sealed envelopes for group allocation code keeping. This was done by a person not involved in data collection.
1.3: N. Quote: "No considerable differences were observed between the intervention and control groups in terms of demographic characteristics, baseline outcome and mediating variables."		 Low risk of bias 2.1: Y; 2.2: PY. Note: Due to the nature of the intervention participants were most likely aware of their allocation.
2.3: PN. Note: No evidence to suggest issues in recruitment and engagement nor failures to implement intervention
2.4: NA.
2.5: NA.
2.6: Y. Note: An ITT analysis was conducted.
2.7: NA.		 Low risk of bias 3.1: PY. Note: Data at end line was missing, due to withdrawal or loss to follow‐up, for 29 participants (circa 24%).
3.2: NA.
3.3: NA.
3.4: NA.		 Some concerns 4.1: PN. Quote: "GDS is easy to administer and is a valid tool for assessing depressive symptoms in individuals with mild cognitive impairment"; The Cronbach’s alpha in this study was 0.784.
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control.
4.3: PY. Note: Outcome assessors (participants) were most likely aware of intervention allocation. Researchers involved in data collection were blinded to group allocation.
4.4: PY; 4.5: PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: PY. Note: no evidence to suggest otherwise, methods and results do not show discrepancies.
5.2: PN. Note: No evidence to suggest outcome selection. All outcomes mentioned in the methods are reported.
5.3: PN. Note: No evidence to suggest analyses selection. All analyses mentioned in the methods were reported.		 Some concerns The study is judged to raise some concerns in one domain (4), but not to be at high risk of bias for any domain.
Ward 2020 Low risk of bias 1.1: PY; 1.2: PY. Quote: "Randomization was conducted after data collection by an off‐site statistician with no other contact with the trial"."
1.3: PN. Baseline characteristics were overall comparable across groups as demonstrated by Table 1.		 High risk of bias 2.1: PY; 2.2: PY. Due to the nature of the intervention participants and personnel were moslt likely aware of their assigned intervention.
2.3: PY. There is some evidence to suggest possible contamination between the intervention and control group. Quote: "In addition, in the dense living environments of informal settlements, it is possible that there was contamination between intervention and control groups."
2.4: PY. Contamination could have affected the outcomes.
2.5: PY. Contamination is more liekly to affect the participants in the control group.
2.6: PY. No explicit mention of the analysis used to estimate the effect of assignment to intervention, but data was analyzed for almost all randomized participants. Quote: "For caregiver self‐report, the follow‐up rate was 97.0% at t1 and 91.9% at t".
2.7: NA.		 Low risk of bias 3.1: PY. Data was availalble for almost all randomized participants. Quote: "For caregiver self‐report, the follow‐up rate was 97.0% at t1 and 91.9% at t"
3.2: NA.
3.3: NA.
3.4: NA.		 Some concerns 4.1: PN. The selected outcome method is widely validated and established across contexts and demonstrated good psychometric properties in the study
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control.
4.3: PY. Outcome assessors (participants) were most likely aware of intervention allocation.
4.4: PY. Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did
4.5: PN.		 Low risk of bias 5.1: PY. No evidence to suggest otherwise, methods and results do not show discrepancies..
5.2: PN. No evidence to suggest outcome selection..
5.3: PN. No evidence to suggest analyses selection. All analyses mentioned in the methods were reported..		 High risk of bias The study is judged to be at high risk of bias in one domain (2).
Yeomans 2010 Low risk of bias 1.1: Y; 1.2: NI.Note: Title mentions RCT design. No further information.
1.3: N. Quote: "There were no significant baseline differences between the three treatment groups across age, gender, ethnicity, symptoms, education level, traumatic events experienced, or on prior exposure to trauma discourse"		 Some concerns 2.1: Y; 2.2: PY. Quote: "Participants (...) were informed of random allocation procedures". Due to the nature of the intervention, the interventionists were most likely aware of the allocation.
2.3: PN. Note: No evidence to suggest issues to implement intervention
2.4: NA.
2.5: NA.
2.6: NI. Note: No explicit mention of the analysis used to estimate the effect of assignment to intervention
2.7: NA. Note: There was not a substantial impact of the failure to analyse participants in the group to which they were randomized		 Low risk of bias 3.1: Y. Note: Lost to follow‐up: 7 of 120
3.2: NA.
3.3: NA.
3.4: NA.		 Some concerns 4.1: N. Note: The selected outcome method (HSCL‐25) is widely validated and established across multiple languages.
4.2: PN. Note: No evidence to suggest differences in measurement between intervention and control.
4.3: PY. Note: Outcome assessors (participants) were most likely aware of intervention allocation.
4.4: PY; 4.5: PN. Note: Knowledge of the assigned intervention could influence participant‐reported outcomes, but there is no reason to believe that it did.		 Low risk of bias 5.1: PY. Note: No evidence to suggest otherwise, methods and results do not show discrepancies.
5.2: PN. Note: No evidence to suggest outcome selection. All outcomes mentioned in the methods and results were reported.
5.3: PN. Note: No evidence to suggest analyses selection. All analyses mentioned in the methods were reported.		 Some concerns The study is judged to raise some concerns in two domains (2 and 4), but not to be at high risk of bias for any domain.