Clarke 2001.
| 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: CES‐D ≥ 24 What risk was basis of inclusion for selected studies: parental depression Diagnostic interview to exclude those with current or previous depression: those with current depression excluded. Those with past episodes of depression, however, were not excluded. Baseline severity of depression: CES‐D: 24.4 (mild) Mean age: 14.6 Age range: 13 to 18 Percentage male: 35.6% Setting: HMO 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: USA |
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| Interventions | Broad category: CBT (for further information on intervention components, see Table 3) Manualised: yes Online: no Name of programme: Coping with Stress Number of sessions: 15 sessions Length of sessions: 60 minutes Intensity (total number of hours): 15 hours Duration of treatment period: unclear Group size: 6 to 10 Delivered by: mental health experts Fidelity: assessed as adequate Type of comparison: TAU comprising freedom to continue with any pre‐existing treatment or to seek new assistance during the study period provided by the HMO and/or by outside healthcare providers |
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| Outcomes | Diagnosis: K‐SADS Name of self‐report depression measure: CES‐D Name of clinical report depression measure: modified 14‐item version of the HAM‐D Name of anxiety measure: N/A Name of general functioning measure: N/A Assessment points: post‐intervention and 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 | "... assignment was preprinted using a computer program..." (p.1129) |
| Allocation concealment (selection bias) | Low risk | "... sealed in sequentially numbered envelopes, which were opened in sequential order by the project coordinator..." (p.1129) |
| Blinding (performance bias and detection bias) Subjects | High risk | The nature of the trial suggests it is unlikely participants could have been blind to the fact they were allocated to treatment as usual. However, without access to the participant information sheets and PLS, level of blinding cannot be ascertained. |
| Blinding (performance bias and detection bias) Assessors | Low risk | "Assessors were unaware of the experimental condition of interviewed subjects" (p.1128) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Proportion of participants with incomplete post‐intervention self‐reported depression scores: 4.30% Means and SDs used in meta‐analysis based on what data: observed cases Intention‐to‐treat analyses: using random‐effects regression |
| 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: yes Implementation integrity adequate: yes Implementation integrity reported: yes |