Law 2015.
| Methods | RCT. 2 arms. Assessed at pretreatment, 1 month post‐treatment, 3 months | |
| Participants | End of treatment: N = 59; 3‐month follow‐up N = 49 Start of treatment: N = 83 Sex: 68 F, 15 M Mean age: 14.5, SD = 1.7, (range 11‐17) Source: multidisciplinary paediatric headache clinic Diagnosis: migraine, tension‐type headache, other headache disorder Duration (mean): not reported | |
| Interventions | "Internet CBT (WebMAP) + specialized headache treatment" "Specialized headache treatment" |
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| Outcomes |
Primary pain outcome: clinical reduction in headache frequency (headache analysis)
Primary disability outcome: Child Activity Limitations Interview‐21 Primary depression outcome: Children's Depression Inventory Primary anxiety outcome: Revised Children's Manifest Anxiety Scale, 2nd edition Primary satisfaction outcome: Treatment Evaluation Inventory‐Short Form Measures reported: Treatment Evaluation Inventory‐Short Form headache frequency headache Pain Intensity Child Activity Limitations Interview‐21 Revised Children's Manifest Anxiety Scale, 2nd edition Children's Depression Inventory Adult Responses to Children's Symptoms total sleep time sleep onset sleep efficiency |
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| Notes |
Funding source: this research was supported by Grant K24HD060068 from the National Institutes of Health/National Institute of Child Health and Human Development (PI: Palermo) Declarations of interest: none stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Blocked randomization with blocks of 10 was used to assign participants to one of the two treatment conditions. An online number generator was used to produce the blocked randomization. Participants were allocated in a 1:1 ratio." Comment: probably done |
| Allocation concealment (selection bias) | Low risk | "Group assignments were identified by ID number in an excel spreadsheet that was password protected and accessible only to a research coordinator who was blinded to participant recruitment, screening, and informed consent. Following completion of all pre‐treatment assessments, the research coordinator accessed the excel spreadsheet to reveal the group assignment. This information was then programmed into the Web‐MAP system, which generated a message on the website to each study participant revealing the instructions for their treatment assignment." Comment: probably done |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Because of the nature of the intervention, it was not possible to blind participants or research staff to group status." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "A research coordinator who was blinded to group status conducted all assessment procedures that occurred in the clinic." Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition is fully reported and authors report that there were no differences between completers and non‐completers |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |