Compas 2009.
| Methods | Design: cluster‐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: parental depression Diagnostic interview to exclude those with current or previous depression: those with current depression excluded. Those with past episodes of depression were not excluded (13% of intervention group and 23% of control group). Baseline severity of depression: YSR depression/anxiety subscale: 55.9 (moderately elevated) Mean age: 11.5 Age range: 9 to 15 Percentage male: 54.8% Setting: mental health clinics/practices, family and general medical practices State what psychiatric diagnoses were excluded: autism spectrum disorders, mental retardation, bipolar I, schizophrenia, conduct disorder, comorbid substance use/disorder, Suicide risk excluded: no Parents with history of schizophrenia/bipolar disorder excluded: those with parents diagnosed with bipolar I, schizophrenia, schizoaffective disorder, substance use/abuse excluded as were those whose parents were currently suicidal 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: not specified Number of sessions: 8 sessions plus 4 booster sessions Length of sessions: unclear. As sessions delivered during visits, assumption is 1 hour. Intensity (total number of hours): 12 hours (on assumption each session has a duration of 1 hour) Duration of treatment period: 8 weeks plus 1 booster session per month for an additional 4 months Group size: 4 families per group Delivered by: mental health experts Fidelity: assessed as adequate Type of comparison: other |
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| Outcomes | Diagnosis: K‐SADS‐PL Name of self‐report depression measure: CES‐D Name of clinician report depression measure: N/A Name of anxiety measure: YSR anxiety subscale 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: yes (not provided) Author contacted for outcome data: yes (not provided) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The order of randomization was determined by a random number generator..." (p.1012) |
| Allocation concealment (selection bias) | Low risk | "...the assignment order was kept in a series of sealed envelopes that were opened by research assistants who were blind to assignment until the envelopes were opened..." (p.1012) |
| 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 | Low risk | "Doctoral candidates in clinical psychology, who were blind to condition, conducted the structured diagnostic interviews..." (p.1011) |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Proportion of participants with incomplete post‐intervention self‐reported depression scores: 29.68% Means and SDs used in meta‐analysis based on what data: unclear Intention‐to‐treat analyses: using multivariate mixed‐effects models with maximum likelihood estimation |
| 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 |