Rapoff 2014.
Methods | RCT. 2 arms. Assessed at pretreatment and post‐treatment | |
Participants | End of treatment: N = 22 Start of treatment: N = 35 Sex: 25 F, 10 M Mean age: 10.2 (SD 1.75) Source: paediatric headache clinics at 1 university and 2 children's hospitals Diagnosis: headache Mean years of pain: unknown | |
Interventions | "Headstrong programme" "Education" |
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Outcomes |
Primary pain outcome: none
Primary disability outcome: Pediatric Migraine Disability Assessment Primary depression outcome: none Primary anxiety outcome: none Primary satisfaction outcome: none Measures reported: headache diaries including frequency, intensity/severity, and duration Pediatric Migraine Disability Assessment Pediatric Quality of Life Inventory |
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Notes |
Funding source: National Institutes of Health (National Institute of Neurological Disorders and Stroke), R01‐NS046641 (PI: Michael Rapoff) Declarations of interest: authors have no conflicts of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Participants were stratified by age (7–9 and 10–12) and randomly assigned following baseline to one of the two groups (education control or Headstrong)." Comment: probably done; description of randomisation not provided |
Allocation concealment (selection bias) | Unclear risk | No description found in text Comment: probably not done |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No description found in text Comment: probably not done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Measures completed at home and mailed back |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition completely reported; significant differences between completers and non‐completers were not reported |
Selective reporting (reporting bias) | Low risk | Data were fully reported |