Palermo 2016.
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 6 months, 12 months (12‐month data not published) | |
| Participants | End of treatment: N = 258, 6 months = 257 Start of treatment: N = 273, 266 received treatment Sex: 205 F, 68 M Mean age: 14.71, SD = 1.62 Source: 15 interdisciplinary paediatric pain clinics at academic medical centres across the US and Canada Diagnosis: headache (7% of the sample), abdominal pain (11% of the sample), or musculoskeletal pain (42% of the sample), Multiple pain sites (40% of the sample) Mean years of pain: not reported | |
| Interventions | "Internet‐delivered family cognitive‐behavioural therapy (WebMAP)" "Internet‐delivered pain education" | |
| Outcomes |
Primary pain outcome: pain intensity (NRS 0 ‐11) over 7 days
Primary disability outcome: Child Activity and Limitations Interview Primary depression outcome: Bath Adolescent Pain Questionnaire‐Depression subscale Primary anxiety outcome: Bath Adolescent Pain Questionnaire‐General Anxiety subscale Primary satisfaction outcome: Treatment Evaluation Inventory‐Short Form Measures reported: daily pain intensity NRS (averaged over 7 days) Child Activity Limitations Interview Bath Adolescent Pain Questionnaire (social functioning, physical functioning, depression, general anxiety, pain‐specific anxiety, family functioning, development subscales) Adolescent Sleep Wake Scale Adult Responses to Children's Symptoms Helping for Health Inventory Treatment Evaluation Inventory‐Short Form website satisfaction treatment engagement treatment expectations |
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| Notes |
Funding source: research reported in this study was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number R01HD062538 (T.M.P. [principal investigator]) 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) | Low risk | "Randomization was implemented using a computer‐generated randomization schedule to derive a randomization assignment to 2 treatment conditions in blocks of 4 for each ID number." Comment: probably done |
| Allocation concealment (selection bias) | Low risk | "The randomization assignment was programmed into the Web‐MAP2 system. After pretreatment assessments, the group assignment was provided to each participant on the Web site with instructions on how to proceed during the treatment phase." Comment: probably done |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Participants were blinded to whether they were receiving an active or control treatment." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Assessments were completed online through our secure, password‐protected Web site independently by adolescents and parents (using separate login procedures) at baseline before randomization, after completion of the 8 to 10 week intervention (immediately after treatment) and at 2 longer‐term follow‐up periods (6 and 12 months). Because all study assessments were completed independently online, there was no possible examiner bias in outcome assessments." 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 |