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

Jaycox 1994.

Methods Design: cluster‐RCT
Conducted by the team who developed the intervention: yes
Participants Description: targeted
Cut‐point for inclusion for indicated studies: ≥ 0.50 on a composite score based on the z score of the CDI and the Child’s Perception Questionnaire of parental conflict. Those scoring below this composite score, however, were included in the trial subject to availability and space in the groups.
What risk was basis of inclusion for selected studies: child’s perception of parental conflict
Diagnostic interview to exclude those with current or previous depression: not undertaken. Unclear whether those with current and/or past episodes of depression were excluded.
Baseline severity of depression: CDI: 9.5 (sub‐threshold)
 
Mean age: 11.4
Age range: 10 to 13
Percentage male: 53.8%
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 Prevention Program (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: 10 to 12
Delivered by: students
Fidelity: not assessed
Type of comparison: WL
Outcomes Diagnosis: established from CDI of ≥ 15
Name of self‐report depression measure: CDI, RADS and a composite measure
Name of clinical report depression measure: N/A
Name of anxiety measure: N/A
Name of general functioning measure: N/A
Assessment points: post‐intervention and 12 weeks (short‐term)
Notes Author contacted for methodological detail: yes (provided)
Author contacted for treatment manual: yes (not provided)
Author contacted for outcome data: no
There were 8 clusters and we assumed 4 in each
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Correspondence with study authors revealed that the randomisation sequence was generated by pulling envelopes were picked out of a hat
Allocation concealment (selection bias) Low risk Correspondence with study authors revealed that the person generating the allocation sequence could not see what was written in each envelope
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 wait‐list 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 All outcomes self‐reported. 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: 15.38%
Means and SDs used in meta‐analysis based on what data: observed cases
Intention‐to‐treat analyses: unclear if undertaken
Selective reporting (reporting bias) High risk Protocol not available. However, the trial commenced with 3 separate intervention groups that were subsequently combined in a post‐hoc manner as there were no differences between them in terms of main outcomes at post‐test.
Other bias High risk Trial conducted by those who developed the intervention
Implementation integrity Unclear risk Implementation integrity assessed: unclear if assessed
Implementation integrity adequate: N/A
Implementation integrity reported: N/A