Risk of bias for analysis 1.9 Distress/PTSD 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

Baker‐Henningham 2019

Low risk of bias

1a.1: PY; 1a.2: Y. Quote: "Schools were randomised to intervention or control group in the summer preceding the intervention selected child. year. Randomisation was conducted by an independent statistician who was blind to the identity of Schools were randomised to intervention or control group in the summer preceding the the schools." 1a.3: NI. Note: No useful information is reported to evaluate this element. 1b.1: PY; Note: schools and teachers were identified and rectruited before the randomization of clusters, children from the teacher's classes were randomly selected at a later stage (outcome of interest refers to teachers); 1b.2 NA; 1b.3 NA;

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 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: all 14 clusters, schools, that recruited participants were analyzed; 3.1b: Y. Note:there was 1 loss among teachers (out of 54), no reported loss among children . 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 differences in measurement between intervention and control 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. Research assistants that were involved in data collection were blind to allocation. 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.

Bell 2008

Low risk of bias

1a.1: Y;1.2: PY. Title mentions RCT design. Quote: "A school was then assigned an experimental school status on the basis of a random pick of all participating schools. A second pick was done of the remaining schools in the area for a control school." 1.3: NI. Note: No information provided about baseline characterists. 1b.1: Y. Quote: "CHAMPSA staff would explain the CHAMPSA program and chools were then requested to indicate if they wished to participate." Then, the schools were randomized for intervention or control group.Overall comment: Low risk.

Some concerns

2.1a: PY; 2.1b: PY. Due to the nature of the intervention, participants were most likely aware that they were in a trial and were aware of their assigned intevrention.Quote: "Active caregiver consent and student assent were obtained before study participation". 2.2: Y. School teachers, health educators and community caregivers were trained as facilitators for the program. 2.3: NI. Note: No information provided. 2.4: NA. 2.5: NA. 2.6: NI. Note: No explicit mention of the analyses used to estimate the effect pf assignment to intervention. 2.7: PN. Note: No evidence to suggest that this had a substantial impact on the results.

Low risk of bias

3.1a: NI. No information provided. 3.1b: Y. Quote: "Ninety‐four percent of families who begna the CHAMPSA HIV prevention intervention completed the netire program. Twenty children and 14 adults did not finish." 3.2: NA. 3.3: NA. 3.4: NA.

Some concerns

4.1: N. Note:The selected outcome method (Social Capital) is validated and established. 4.2: PN. Quote: "Measures were obtained before and once after participation in the intervention". No evidence to suggest differences in measurement between intervention and control. 4.3a: Y. The outcome assessors (caregiver) were aware that the trial was taking place. 4.3b: Y. The outcome assessors (caregiver) were aware of the intervention received by study participation. 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: PN. Note: The data were collected n additional sessions before and after the program session due the loe‐literacy levels of by reading aloud the items by adult participants. 5.2: PN. Note: no protocol available.No evidence to suggest outcome selection. All outcome mentioned in the methods and results were reported. 5.3: PN. No protocol available. No evdience 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 three domains (2, 4, 5), but not to be at high risk of bias for any domain.

Duan 2019

Some concerns

1.1: PY; 1.2: NI. Quote: "Randomization was conducted through computer random number generators." 1.3: PN. Quote: "no significant difference in the preassessment variables between the two groups"

Some concerns

2.1: PY; 2.2: PY. Note: Due to the nature of the intervention participants and personnel were most likely aware of 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. Data was analyzed for participants whose follow‐up data was available (73%) 2.7: PN. No evidence to suggest analysis in the wrong group or exclusion of participants that could have had a substantial impact on the results

Some concerns

3.1: PN. Note: Out of the 52 randomized participants, 14 (27%) were lost at follow‐up (1 week after intervention). At post‐intervention, the rate was of 21%. 3.2: PN. Note: No information to suggest that results were not biased by missing outcome data. 3.3: PY. Note: Missing data occurred for reasons that could be related to at least one of the assessed outcomes.The dropouts were balanced across comparison groups. Quote: "the dropout rate was 27% because the data were collected by means of online questionnaire and a few students forgot to complete the measures in time". 3.4: PN.

High risk of bias

4.1: N. Note: The selected outcome method (BIT) is established, validated for the local context, and assessed in its psychometric properties for this sample. 4.2: PY. Note: It appears that different data collection methods were used at post‐intervention for the control and intervention group. Quote: "At the end of the lesson, the intervention group was asked to fill out the postintervention test immediately, and the data of control group were obtained through online questionnaires within the same day." 4.3: NA. Note: Outcome assessors (participants) were most likely aware of intervention allocation. 4.4: NA. 4.5: NA.

Some concerns

5.1: NI. Note: Information provided is insufficient to make a judgment on this item as a specific method section for statistical procedures is missing. 5.2: NI. Note: Information provided is insufficient to make a judgment on this item as a specific method section for statistical procedures is missing. 5.3: NI. Note: Information provided is insufficient to make a judgment on this item as a specific method section for statistical procedures is missing.

High risk of bias

The study is judged to be at high risk of bias in one domain (4).

Hendriks 2019

Low risk of bias

1.1: Y; 1.2: PY. Note: Quote: "Participants were randomly assigned to either the intervention group (n = 87) or the wait‐list control group (n = 86), using the online program research randomizer (https://www.randomizer.org)."; "At the end of the session they received a sealed opaque envelope containing their given group number, which corresponded to one of the conditions. This procedure was performed by a different independent party to maximize allocation concealment." 1.3: PN. Quote: "No significant differences of socio‐demographics between groups were found, except for gender and ethnicity, with an overrepresentation of male participants from Javanese descent in the intervention group."

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 allocation. 2.3: PN. Note: No evidence to suggest issues to implement intervention. 2.4: NA. 2.5: NA. 2.6: Y. Quote: "Of the 173 randomized participants, 15 did not attend the baseline assessment due to work‐related scheduling conflicts. These absences were unrelated to the randomization itself and were the result of workflow processes, not individual volition. Due to these initial drop‐outs, a modified intention‐to‐treat (mITT) analysis was used" 2.7: NA.

Low risk of bias

3.1: PY. Quote: "In total, 158 participants completed the baseline assessment and started the intervention, 144 (91%) participants completed the post‐test at seven weeks, and 120 (76%) the three month follow‐up assessment." 3.2: NA. 3.3: NA. 3.4: NA.

Some concerns

4.1: PN. Quote: "Cronbach’s alpha in the present study was .89 at pretest, .92 at post‐test, and.94 at follow‐up." 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. The investigators in the trial 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.

Low risk of bias

5.1: PN. 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 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.