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. 2016 Aug 9;2016(8):CD003380. doi: 10.1002/14651858.CD003380.pub4

Gillham 2007.

Methods Design: RCT
Conducted by the team who developed the intervention: yes
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: those with current depression excluded. Unclear whether those with past depression were also excluded, however.
Baseline severity of depression: CDI: 8.4 (subthreshold)
 
Mean age: 12.1
Age range: 11 to 14
Percentage male: 54.1%
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: USA
Interventions Broad category: CBT (for further information on intervention components, see Table 3)
Manualised: yes
Online: no
Name of programme: Penn Resiliency Program
Number of sessions: 12 sessions
Length of sessions: 90 minutes
Intensity (total number of hours): 18 hours
Duration of treatment period: 12 weeks
Group size: 6 to 14
Delivered by: all
Fidelity: assessed as satisfactory to good
Type of comparison: AP
Outcomes Diagnosis: established from CDI of ≥ 13.0 or from clinically significant symptoms on the CDRS‐R of ≥ 65.0
Name of self‐report depression measure: CDI
Name of clinician report depression measure: CDRS‐R
Name of anxiety measure: N/A
Name of general functioning measure: N/A
Assessment points: post‐intervention, 12 months (medium‐term) and 36 months (long‐term)
Notes Author contacted for methodological detail: no
Author contacted for treatment manual: no (manual freely available on request)
Author contacted for outcome data: no
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "... computer‐generated random numbers sequence" (p.10)
Allocation concealment (selection bias) Unclear risk No information specified
Blinding (performance bias and detection bias) 
 Subjects Low 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 Low risk "Interviewers and coders were not informed of participants'... assignments" (p.13)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Proportion of participants with incomplete post‐intervention self‐reported depression scores: 8.86%
Means and SDs used in meta‐analysis based on what data: observed cases
Intention‐to‐treat analyses: undertaken, but based on only those who completed baseline and at least one post‐intervention assessment
Selective reporting (reporting bias) High risk Protocol not available. However, CDRS‐R raw scores are not presented nor are the proportion of children with elevated, high, and clinically significant levels of depression.
Other bias High risk Trial conducted by those who developed the intervention
Implementation integrity Low risk Implementation integrity assessed: yes
Implementation integrity adequate: described as "adequate to good"
Implementation integrity reported: yes