Fleming 2012.
| Methods | Design: RCT Conducted by the team who developed the intervention: yes |
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| Participants | Description: targeted Cut‐point for inclusion for indicated studies: N/A What risk was basis of inclusion for selected studies: students excluded, or at risk of being excluded, from mainstream education due to behavioural problems Diagnostic interview to exclude those with current or previous depression: not undertaken, although those with “extreme depression” were excluded (p.531). Unclear whether those with past episodes of depression were also excluded Baseline severity of depression: CDRS‐R: 39.6 (moderate) Mean age: 14.9 Age range: 13 to 16 Percentage male: 56.0% Setting: schools (alternative education) State what psychiatric diagnoses were excluded: "Only those judged not to be safe using the computerized program were excluded" (p.531) Suicide risk excluded: yes Parents with history of schizophrenia/bipolar disorder excluded: no Country: New Zealand |
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| Interventions | Broad category: CBT (for further information on intervention components, see Table 3) Manualised: N/A Online: yes Name of programme: SPARX Number of sessions: 7 modules Length of sessions: 30 minutes Intensity (total number of hours): 3.5 hours Duration of treatment period: 5 weeks Group size: unclear Delivered by: online Fidelity: online, therefore standardised Type of comparison: WL |
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| Outcomes | Diagnosis: N/A Name of self‐report depression measure: RADS‐2 Name of clinician report depression measure: CDRS‐R Name of anxiety measure: SAS Name of general functioning measure: PQ‐LES‐Q Assessment points: post‐intervention |
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| Notes | Author contacted for methodological detail: no Author contacted for treatment manual: no Author contacted for outcome data: yes (provided) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization was carried out in a 1:1 ratio using a computer generated randomization sequence. Allocation was stratified by study site and arranged in permuted blocks" (p.533) |
| Allocation concealment (selection bias) | Low risk | "Allocation concealment was ensured by allocating each participant a unique study number..." (p.533) |
| Blinding (performance bias and detection bias) Subjects | High risk | "It was not possible to blind participants to their treatment allocation" (p.533) |
| Blinding (performance bias and detection bias) Assessors | High risk | "The researcher was unblinded after the baseline assessment" (p.533) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Proportion of participants with incomplete post‐intervention self‐reported depression scores: 6.30%; 0% (for depression diagnosis) Means and SDs used in meta‐analysis based on what data: observed cases (defined as those who completed at least one SPARX module and completed the 5 week post‐treatment assessment Intention‐to‐treat analyses: ITT analyses were undertaken, however, the sample was not large enough to form the primary outcome |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |
| Other bias | High risk | Trial conducted by those who developed the intervention |
| Implementation integrity | Low risk | Implementation integrity assessed: N/A (standardised) Implementation integrity adequate: N/A Implementation integrity reported: N/A |