Stallard 2012a.
Methods | Design: cluster‐RCT Conducted by the team who developed the intervention: no |
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Participants | Description: targeted Cut‐point for inclusion for indicated studies: MFQ ≥ 2.0 over 2 assessments approx. 2 weeks apart What risk was basis of inclusion for selected studies: N/A Diagnostic interview to exclude those with current or previous depression: diagnostic interview not used to exclude those with current depression. Those with past episodes of depression not excluded. Baseline severity of depression: SMFQ: 10.6 (subthreshold) Mean age: not specified Age range: 8 to 11 Percentage male: 34.9% Setting: school State what psychiatric diagnoses were excluded: none Suicide risk excluded: no Parents with history of schizophrenia/bipolar disorder excluded: no Country: UK |
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Interventions | Broad category: CBT with elements of IPT (for further information on intervention components, see Table 3) Manualised: yes Online: no Name of programme: RAP Number of sessions: 9 sessions and 2 booster sessions Length of sessions: 50 to 60 minutes Intensity (total number of hours): up to 9 hours (not including booster sessions) Duration of treatment period: unclear Group size: unclear Delivered by: students with at least an undergraduate degree in a relevant discipline Fidelity: assessed as adequate Type of comparison: TAU comprising usual personal health and social education classes provided by the school |
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Outcomes | Diagnosis: SMFQ ≥ 5.0 Name of self‐report depression measure: SMFQ Name of clinical report depression measure: N/A Name of anxiety measure: RCADS Name of general functioning measure: N/A Assessment points: 12 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) | Low risk | "...we allocated year groups on a 1:1:1 ratio. We balanced the trial arms for key characteristics by calculating an imbalance statistic for a large random sample of possible allocation sequences" (no pagination specified). |
Allocation concealment (selection bias) | Low risk | "A statistician with no other involvement in the study randomly selected one sequence from a subset..." (no pagination specified) |
Blinding (performance bias and detection bias) Subjects | Unclear risk | The nature of the trial suggests it is likely participants could have remained blind to the fact they were allocated to a placebo 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 | Outcomes self‐reported but there is no detail about blinding. Assessor blinding therefore not applicable. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Proportion of participants with incomplete post‐intervention self‐reported depression scores: 21.1% Means and SDs used in meta‐analysis based on what data: observed cases Intention‐to‐treat analyses: multiple imputation |
Selective reporting (reporting bias) | Low risk | Trial protocol (i.e. Stallard 2010) would suggest that all intended outcomes were assessed |
Other bias | Low risk | Trial not conducted by those who developed the intervention |
Implementation integrity | Low risk | Implementation integrity assessed: yes (5% of sessions) Implementation integrity adequate: 89.00% of sessions covered core tasks, with at least 75% of the core tasks covered in the remaining 11% of sessions Implementation integrity reported: yes |