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

Risk of bias for analysis 4.3 Psychological functioning and impairment 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
Amador Buenabad 2020 Low risk of bias 1a.1: Y; 1b.2: Y. Note: Title mentions cluster RCT design. 
Quote: "The sample was randomized at the school level (...). All the randomization processes used the lottery method. As for the experimental conditions, schools, participants, teaching staf, statisticians, supervisors, and evaluators were blinded throughout the study until the pre‐test
was completed. In order to avoid communication between participants, each school was in
a diferent area in the south of the city.
1.3: PN. Note: Not significant differences at baseline
1b.1: PN. the participants were recruited after school‐randomization. Quote: ". Once schools agreed to engage in the research
project, teachers, caregivers and children were invited to information meetings. At these meetings, written informed consent was obtained from all adult participants and parents of all nonadult participants. Written informed assent was obtained from the children (...). Participants were assessed in February and June 2016,
before and after the intervention."
1b.2: PN there is no evidence to suggest that selection was affected by knowledge of the intervention assigned to the cluster; 1b.3: PN. Some baseline imbalances are presents but compatible with chance		 Some concerns 2.1a: PY. Quote: "written informed consent was obtained from all adult participants and parents of all nonadult participants. Written informed assent was obtained from the children"
2.1b: PY. Quote: "As for the experimental conditions, schools, participants, teaching staf, statisticians, supervisors, and evaluators were blinded throughout the study until the pre‐test
was completed"
2.2: PY. People delivering the intervention (teachers) were trained for doing that. They were most likely aware of their assigned intervention.
2.3: PN. Note: No evidence to suggest deviations from the intended intervention taht arose because of the trial context.
2.4: NA.
2.5: NA.
2.6: NI. Note: No information provided.
2.7: PN. Note: There is no reason to believe that it did.		 Low risk of bias 3.1a: PY. 3.1b: PY. Dropout: 2 for Huellitas intervention, 0 for control group.
3.2: NA.
3.3: NA; 3.4: NA.		 Some concerns 4.1: N. Quote: "The reliability for the present sample was.83"
4.2: PN. Note: no evidence to suggest differences in measurement between intervention and control groups.
4.3a: Y. Outcome assessors (participants) were most likeley aware that a trial was taking a place.
4.3b: PY. Due to the nature of intervention, ouctome assessors (research assistants + participants) are most likely aware of the intervention 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: PN. Note: Protocol is available.
No evidence to suggest otherwise, protocol and manuscript do not show discrepancies.
5.2: PN. Note: No evidence to suggest outcome selection. All outcomes mentioned in the methods and protocol were reported
5.3: PN. Note: No evidence to suggest analyses selection. All outcomes mentioned in the methods and protocol 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.
Berger 2018 Low risk of bias 1a.1: Y; 1a.2: PY. Quote: "The principal of this school randomply chose (by tossing a coin) to implement the ESPS (experimental group) in only one of the two classes in each of the 4th‐6th grades, while the other classes participated in Social Studies (SS, control group)."
1.3: N. Quote: "No significant differences were found at baseline (prior to the intervention) between the intervention and control group for any of the outcome measures"
1b.1: Y. Quote: "The ESPS program was presented to all the principals from the primary schools in the Meru district. (...). Since we had limited funds, we randomly chose (by tossic dice) one school for the study."		 Some concerns 2.1a: PY; 2.1b: PY. Quote: "All the parents or guardians whose children were assigned to the ESPS consented to their children's participation in the study and expressed support for the program"
2.2: Y. The teachers were trained in a workshop by the first author for the experimental exercises"
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: NI. Note: Not enough information provided to give a judgemnet on this item.
2.7: PN. Note: No evidence to suggest that failure to analyzed participants in randomized groups could a substantial impact on the results.		 Low risk of bias 3.1a:PY. No evidence to suggest cluster loss.
3.2: NA.
3.3: NA.
3.4: NA.		 Some concerns 4.1: N. Note: The selected outcome method (Spence Anxiety scale for children‐SCAS) is validated and established. Quote: "Cronbach alpha in current sample was 0.74)"
4.2: PN. No evidence to suggest that measurement or ascertainment of the outcome differed between intervention groups.
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. Note: No protocol available.
5.2: PN. Note: No evdience 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.