Palermo 2009.
Methods | RCT. 2 arms. Assessed at pretreatment and post‐treatment | |
Participants | End of treatment: N = 44 Start of treatment: N = 48 Sex: 35 F, 13 M Mean age: 14.8 (SD 2.0) Source: medical centre in the Pacific Northwest USA Diagnosis: headache (25% of the sample), abdominal pain (50% of the sample), or musculoskeletal pain (25% of the sample) Mean years of pain: 30 months | |
Interventions | "Internet‐delivered family cognitive‐behavioural therapy" "Wait‐list control group" | |
Outcomes |
Primary pain outcome: clinical reduction in headache frequency (headache analysis) and mean pain intensity (mixed chronic pain conditions analysis)
Primary disability outcome: Child Activity and Limitations Interview Primary depression outcome: Revised Child Anxiety and Depression Scale Primary anxiety outcome: none Primary satisfaction outcome: treatment acceptability and satisfaction Measures reported: daily pain intensity NRS (averaged over 7 days) usual pain intensity over the past month NRS Child Activity Limitations Interview Revised Child Anxiety and Depression Scale Protect subscale from Adult Responses to Children's Symptoms treatment acceptability and satisfaction |
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Notes |
Funding source: National Institutes of Health/National Institute of Child Health and Human Development (Grant HD050674; PI: Palermo) and by a grant from the Doernbecher Foundation 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 | "A fixed allocation randomisation scheme was used. Specifically, we used blocked randomisation with blocks of 10 to assign participants to the two treatment conditions during the course of randomisation. An online random number generator was used to produce the blocked randomisation. Group assignments were identified by ID number in sealed envelopes. Following completion of all pre‐treatment assessments, a research coordinator opened the sealed envelope to reveal the group assignment." Comment: probably done |
Allocation concealment (selection bias) | Low risk | "A fixed allocation randomisation scheme was used. Specifically, we used blocked randomisation with blocks of 10 to assign participants to the two treatment conditions during the course of randomisation. An online random number generator was used to produce the blocked randomisation. Group assignments were identified by ID number in sealed envelopes. Following completion of all pre‐treatment assessments, a research coordinator opened the sealed envelope to reveal the group assignment." Comment: probably 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 submitted online or 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 |