Gallegos 2008.
| Methods | Design: cluster‐RCT Conducted by the team who developed the intervention: no |
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| Participants | Description: universal Cut‐point for inclusion for indicated studies: N/A What risk was basis of inclusion for selected studies: N/A Diagnostic interview to exclude those with current or previous depression: not undertaken Baseline severity of depression: CDI: 9.4 (sub‐threshold) Mean age: 9.9 Age range: 9 to 11 Percentage male: 47.4% Setting: school State what psychiatric diagnoses were excluded: exclusion criteria not specified Suicide risk excluded: exclusion criteria not specified Parents with history of schizophrenia/bipolar disorder excluded: exclusion criteria not specified Country: Mexico |
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| Interventions | Broad category: CBT (for further information on intervention components, see Table 3) Manualised: yes Online: no Name of programme: AMISTAD (Mexican version of the FRIENDS for Life program) Number of sessions: 10 sessions plus 2 booster sessions Length of sessions: 60 to 75 minutes Intensity (total number of hours): up to 12.5 hours (including booster sessions) Duration of treatment period: 10 weeks (booster sessions at 1 month and 3 months post‐intervention) Group size: unclear Delivered by: non‐mental health experts Fidelity: assessed as adequate Type of comparison: NT |
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| Outcomes | Diagnosis: established from CDI of ≥ 19.0 Name of self‐report depression measure: CDI (Spanish version) Name of clinician report depression measure: N/A Name of anxiety measure: SAS (Spanish version) Name of general functioning measure: N/A Assessment points: post‐intervention and 6 months (medium‐term) |
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| Notes | Author contacted for methodological detail: no Author contacted for treatment manual: no Author contacted for outcome data: no |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Schools... were randomly assigned..." (p.62) Method of randomisation not specified, however |
| Allocation concealment (selection bias) | Unclear risk | No information specified |
| Blinding (performance bias and detection bias) Subjects | High risk | The nature of the trial suggests it is unlikely participants could have remained blind to the fact they were allocated to a no treatment control group. However, without access to the participant information sheets and PLS, level of blinding cannot be ascertained. |
| Blinding (performance bias and detection bias) Assessors | Unclear risk | No information specified |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Proportion of participants with incomplete post‐intervention self‐reported depression scores: 10.8% Means and SDs used in meta‐analysis based on what data: observed cases Intention‐to‐treat analyses: not undertaken |
| Selective reporting (reporting bias) | Low risk | As this trial was reported in a thesis, it is unlikely selective outcome reporting was present |
| Other bias | Unclear risk | No information specified |
| Implementation integrity | Unclear risk | Implementation integrity assessed: yes (for 17.00% of cases) Implementation integrity adequate: unclear Implementation integrity reported: N/A |